Normal Newborn

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NNF CPG guidelines: Care of Normal Newbon
Technical Report · November 2023
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Care of the Normal Newborn
Care of the Normal Newborn - National Neonatology Forum of India
NNF/2023/CPG/2023.2.0
©National Neonatology Forum of India 2023
Some rights reserved. This work is licensed under Attribution-NonCommercial-ShareAlike 4.0 International. To view a copy of this
license, visit http://creativecommons.org/licenses/by-nc-sa/4.0/ This license requires that you must give credit to the creator. It allows
you to distribute, remix, adapt, and build upon the material in any medium or format, for noncommercial purposes only. If you modify
or adapt the material, you must license the modified material under identical terms.
Suggested citation: Care of the normal newborn. 25 November 2023. New Delhi: National Neonatology Forum of India; 2023 (NNF/
2023/CPG/ 2023.2.0). License: CC BY-NC-SA 4.0
Disclaimers: Due care has been taken to verify the accuracy of all the information in these Clinical Practice Guidelines. However, the
contributors, editors, or National Neonatology Forum are not responsible for errors or omissions or any consequences from the
application of information provided in this book and give no guarantee concerning the completeness or accuracy of the contents.
Application of the information in a situation different from that described in guidelines remains the professional responsibility of the
concerned physicians. The guidelines do not endorse any particular brand of equipment or drug. The contributors, editors, and NNF
have no affiliation with any of the companies.
The contributors and editors have made great efforts to ensure that all information is according to currently accepted
recommendations. However, given the rapidity with which such information changes, the reader is urged to check the latest updates.
Updates as and when they occur, shall be posted on the website of NNF and published in the issues of the official journal of NNF, the
Journal of Neonatology.
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National Neonatology Forum of India
About us: National Neonatology Forum (NNF), established in 1980, is the professional association of neonatologists of India. It
currently has more than 9000 members (https://www.nnfi.org/about-us). NNF has been instrumental in bringing up neonatology and
neonatal care services in India to the forefront. It is actively involved in advocacy, policy-making, capacity-building, and improving
quality of care. One of its important mandates is to draw out evidence-based recommendations for neonatal care at different levels.
The members of NNF have developed expertise and experience in using GRADE methodology and have released several clinical
practice guidelines over the years which are available online (https://www.nnfi.org/cpg) as well as in Google and Apple Playstores (NNF
CPG) as app.
E-mail: secnnf@nnfi.org
Office-bearers 2022:
President: Dr. Siddharth Ramji

President-Elect: Dr. Praveen Kumar
Secretary: Dr. Dinesh Tomar
Past President: Dr. Ranjan Kumar Pejaver
Vice President: Dr. Vikram Dutta
Treasurer: Dr. Surender Bisht
Jt. Secretary: Dr. Dinesh Chirla
Office-bearers 2023:
President: Dr. Praveen Kumar

President-Elect: Dr. Sushma Nangia
Secretary: Dr. Surender Bisht
Past President: Dr. Siddharth Ramji
Vice President: Dr. Alok Bhandari
Treasurer: Dr. Amit Upadhyay
Jt. Secretary: Dr. Srinivas Murki
Immediate Past Secretary General: Dr. Dinesh Tomar
Contact
Dr Deepak Chawla
Professor, Department of Neonatology, Government Medical College Hospital, Chandigarh, India
drdeepak@gmch.gov.in
https://www.nnfi.org
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Sections
Summary of recommendations ................................................................................................................................................................................................................ 5
1. Contributors ................................................................................................................................................................................................................................................. 8
2. Introduction ................................................................................................................................................................................................................................................. 9
3. Scope of the guidelines ........................................................................................................................................................................................................................ 10
4. Methodology ............................................................................................................................................................................................................................................ 11
5. Among healthy neonates roomed in with the mother, is lactation support by a specifically assigned counselor or nurse superior to
support by healthcare staff providing routine medical care? .................................................................................................................................................... 16
6. Among healthy neonates, is assessment of weight before discharge from the hospital superior to no assessment of weight?.............. 21
7. Among healthy neonates weighing >1800 g, is daily oral vitamin D supplementation superior to no supplementation? ......................... 27
8. Among healthy neonates weighing >1800 g, is body massage with or without oil superior to no body massage? .................................... 34
9. Among healthy neonates, is chlorhexidine or any other antiseptic application on the umbilical cord stump superior to dry cord
care?.................................................................................................................................................................................................................................................................. 39
10. Among healthy neonates, is the instillation of antibiotic eye drops at birth superior to no antibiotic instillation? ..................................... 46
11. Among healthy neonates weighing >1800 g, are post-discharge home visits by a healthcare worker superior to no home visits? ... 53
12. Among healthy neonates weighing >1800 g, is purposive sunlight exposure superior to no sunlight exposure? ...................................... 58
13. Among healthy neonates weighing >1800 g, is bathing with soap superior to bathing without soap? .......................................................... 63
14. Among healthy neonates weighing >1800 g, is sleeping in the supine position superior to sleeping in a non-supine position (prone
or side or changing positions)? ............................................................................................................................................................................................................ 70
15. Among healthy neonates weighing >1800 g, is rooming in on the mother’s bed superior to rooming in on a side crib? ...................... 74
16. Among healthy neonates weighing >1800 g and roomed in with the mother is Kangaroo Mother Care (KMC) superior to a) no KMC
or b) the use of other hypothermia prevention measures/devices? ...................................................................................................................................... 78
References ...................................................................................................................................................................................................................................................... 83
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Summary of recommendations
1. Contributors
2. Introduction
3. Scope of the guidelines
4. Methodology
5. Among healthy neonates roomed in with the mother, is lactation support by a

specifically assigned counselor or nurse superior to support by healthcare staff providing
routine medical care?
Strong recommendation , Moderate certainty evidence
Mothers of term and late preterm neonates should be provided lactation support by a counselor or nurse whose sole or
main responsibility is lactation counseling. This support should be provided at the time of delivery and during the
hospital stay after childbirth.
6. Among healthy neonates, is assessment of weight before discharge from the hospital
superior to no assessment of weight?
Weak recommendation , Low certainty evidence
Neonates may be weighed prior to discharge from the hospital to identify those with excessive weight loss. Early
discharge may be deferred in neonates showing weight loss ≥8% or examined by a healthcare worker within 48-72 hours
of discharge.
7. Among healthy neonates weighing >1800 g, is daily oral vitamin D supplementation

superior to no supplementation?
Daily oral vitamin D supplements (400 IU/day) for 3-6 months should be administered to term breastfed neonates and
infants to prevent vitamin D deficiency.
8. Among healthy neonates weighing >1800 g, is body massage with or without oil
superior to no body massage?
Weak recommendation , Very low certainty evidence
Body massage with or without oil is not likely to have substantial beneficial or harmful effects on the health of healthy
neonates. The family may choose to massage the infant based on their cultural practice.
9. Among healthy neonates, is chlorhexidine or any other antiseptic application on the

umbilical cord stump superior to dry cord care?
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The umbilical cord should be kept clean and dry.
Conditional recommendation: Chlorhexidine may be applied to the umbilical cord in term or late preterm infants in
settings with a high neonatal mortality rate (>30 per 1000 live births) or a high incidence of omphalitis.
10. Among healthy neonates, is the instillation of antibiotic eye drops at birth superior to
no antibiotic instillation?
Weak recommendation against , Very low certainty evidence
Prophylactic antibiotic eye drops may not be used in neonates at birth for prevention of ophthalmia neonatorum.
11. Among healthy neonates weighing >1800 g, are post-discharge home visits by a
healthcare worker superior to no home visits?
Designated healthcare workers should conduct regular home visits to assess the health of the neonate and provide health
education to the family.
12. Among healthy neonates weighing >1800 g, is purposive sunlight exposure superior
to no sunlight exposure?
Neonates may not be placed under direct sunlight due to a lack of robust evidence on its benefits and a lack of data on
safety.
13. Among healthy neonates weighing >1800 g, is bathing with soap superior to bathing
without soap?
Soap may not be used for bathing healthy term neonates during the first 4 weeks of life.
However, soap should be used for cleansing the visibly soiled skin of the neonate at home. Parents and other caregivers
should use soap and water for hand hygiene (Good Clinical Practice in accordance with the WASH guidelines).
14. Among healthy neonates weighing >1800 g, is sleeping in the supine position
superior to sleeping in a non-supine position (prone or side or changing positions)?
Strong recommendation , Low certainty evidence
Healthy neonates should be placed in a supine position during sleep.
15. Among healthy neonates weighing >1800 g, is rooming in on the mother’s bed
superior to rooming in on a side crib?
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Mother and neonate should be roomed-in soon after birth. However, while roomed-in, the mother and the neonate may
not share the same bed.
16. Among healthy neonates weighing >1800 g and roomed in with the mother is
Kangaroo Mother Care (KMC) superior to a) no KMC or b) the use of other hypothermia
prevention measures/devices?
Strong recommendation , Very low certainty evidence
Kangaroo Mother care (KMC) should be practiced to prevent hypothermia in stable neonates born with a birth weight of
1800-2500 g. KMC may be continued even after discharge to home.
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1. Contributors
Guideline Development Group (alphabetical order)

Dr Abiramalatha MD, DM, PhD; Associate Professor of Neonatology, KMCH Institute of Health Sciences and Research, Coimbatore,
Tamil Nadu
Dr Akash Sharma MD, DM; Consultant Neonatologist & Pediatrician, Incharge NICU, Surya Hospitals, Jaipur, Rajasthan
Dr. Anu Sachdeva (Chairperson) MD, DM; Additional Professor, Division of Neonatology, Department of Pediatrics, All India Institute
of Medical Sciences, New Delhi
Dr Deepika Kainth MD, DM; Assistant Professor, Division of Neonatology, Department of Pediatrics
All India Institute of Medical Sciences, New Delhi
Dr G Shridhar MD, DM; Professor, Department of Pediatrics, Armed Forces Medical College, Pune
Dr Shivashankar Diggikar MD, FRCPCH (U.K), MRCPCH, MBA, Fellowship in Neonatal-Perinatal Medicine (RCPCH Affiliate, London);
Co-founder and Consultant Neonatologist, Oyster Woman and Child Speciality Hospital, Bangalore
Dr Vishal Vishnu Tewari MD, DNB; Professor of Pediatrics & Consultant Neonatologist, Commandant,
Military Hospital Roorkee, Uttarakhand
Reviewers
Dr. Aarti Maria, Professor, Department of Neonatology, RML Hospital, New Delhi
Dr. Jayaraman Kumutha, Professor, Department of Neonatology, Saveetha Medical College, Thandalam
Dr. Ramesh Agarwal, Professor, Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Editorial coordinator
Dr. Deepak Chawla, Professor, Department of Neonatology, Government Medical College Hospital, Chandigarh
Editors (alphabetical order)

Dr. Deepak Chawla (Chairperson), Professor, Department of Neonatology, Government Medical College Hospital, Chandigarh
Dr. Jeeva Sankar, Additional Professor, Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, New
Delhi
Dr. Praveen Kumar (Advisor), Professor, Neonatal Unit, Department of Pediatrics, PGIMER, Chandigarh
Dr. Sindhu Sivanandan, Senior Consultant Neonatologist, Kauvery Hospital, Chennai
Dr. Viraraghavan Vadakkencherry Ramaswamy, Consultant Neonatologist, Ankura Hospital, Hyderabad
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2. Introduction
Infants who die within the first 28 days of birth suffer from conditions and diseases associated with a lack of quality care at birth or skilled
care and treatment immediately after birth and in the first days of life. According to the World Health Organization (WHO), India tops
the list of newborn deaths, with nearly 520 thousand deaths in the year 2019 [1][2]. The transition from the intrauterine to extrauterine
environment and the postnatal adaptation imposes various challenges failing which a healthy newborn can become sick and require
specialized care. There are wide variations in the care of a normal newborn affected by regional beliefs and customs, resource availability,
institutional practices, and knowledge and skills of healthcare providers. A significant proportion of births are domiciliary births, even
though this has markedly reduced due to the concerted efforts of various government programs aimed at improving institutional births
and facility-based care [3].
In the realm of healthcare, normal newborn care guidelines are indispensable tools for healthcare professionals, guiding them in
delivering consistent, high-quality care to newborns and their families. These guidelines cover a spectrum of essential topics, including,
resuscitation of the newborn, umbilical cord management, thermoregulation after birth, first feed, administration of Vitamin K,
prevention of infection, and identification of danger signs etc. Establishment of breastfeeding, screening for neonatal jaundice, and
care of the umbilical cord stump are also essential prior to hospital discharge. Screening for congenital heart disease by pulse
oximetry, clinical examination for developmental dysplasia of the hip, and hearing screening by otoacoustic emission are essential in
the postnatal period. Many learning needs arise in the early postpartum period, and it is important to examine interventions used to
educate new parents about caring for their newborns during this time.
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3. Scope of the guidelines
Aim
The target audience for these guidelines consists of healthcare providers – including pediatricians, neonatologists, nurses, and
community health workers, who look after newborn infants and provide advice to the families. neonatologists, and community health
workers. The guidelines can also be used by state and national health administrators, program managers and policymakers to improve
the organization and delivery of neonatal health services.
Target audience
These guidelines are applicable to the following group of neonates.
• Term healthy neonates weighing > 2500 g at birth who have stable vital parameters and are roomed-in with the mother.
• Low birth weight neonates weighing 1800 to 2500 g at birth who have stable vital parameters and are roomed-in with the mother.
• Neonates weighing>1800 g who have stable vital parameters but need closer monitoring due to transient perinatal conditions.
These neonates are often monitored while being roomed-in with the mother. This group includes neonates with the following
conditions:
◦ Birth asphyxia (need for positive pressure ventilation at birth but no HIE),
◦ Moderate jaundice requiring phototherapy,
◦ Birth weight >97 percentile - large for gestation age or <3rd centile - small for gestation age
This guideline document addresses the care practices common to the above groups of neonates. Other specific guidance documents
address the practice questions specific to LBW neonates (e.g., LBW feeding) or neonates needing monitoring due to specific conditions
(e.g., monitoring for hypoglycemia)
Setting
These guidelines apply to level 1 neonatal care (postnatal wards or any other ward where such babies are roomed in with the mother)
and care at home.
How to use these guidelines

This guideline document has twelve recommendations. Each recommendation was graded as strong when there was confidence that
the benefits clearly outweighed the harms, or weak when the benefits probably outweighed the harms, but there was uncertainty
about the trade-offs. A strong or weak recommendation was further classified as conditional if the benefits outweigh the harms in
some situations but not in others. For example, some recommendations were relevant only to resource-limited settings while others
were considered relevant only to settings where certain types of facilities are available. To ensure that each recommendation is
correctly understood and applied in practice, the context of all context-specific recommendations is clearly stated within each
recommendation, and additional remarks are provided where needed. Users of the guideline should refer to these remarks, which are
presented along with the evidence summaries within the guideline.
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4. Methodology
The steps followed in writing the CPG are summarized below and in Figure 1.
Figure 1: Steps in formulation of Clinical Practice Guidelines
Prioritization of questions
The guideline author panel included neonatologists working in tertiary care hospitals. A set of 18 questions and outcomes of interest
were identified by the guideline writing group. As a large number of questions were identified, it was decided by the editorial group to
further prioritize which questions should be addressed on priority. For this, the Delphi process was conducted in which a broader
group of neonatologists and stakeholders were asked to provide priority scores to each question through an online survey.
Questions relevant to clinical practice
Based on the feedback from participants, the following list of questions was identified as being the most relevant to clinical practice.
A. Questions related to care during birth hospitalization
1. Among healthy neonates roomed in with the mother, is lactation support by a specifically assigned counselor or nurse superior to
support by healthcare staff providing routine medical care?
2. Among healthy neonates, is chlorhexidine or any other antiseptic application on the umbilical cord stump superior to dry cord
care?
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3. Among healthy neonates, is the instillation of antibiotic eye drops at birth superior to no antibiotic instillation?
4. Among healthy neonates weighing >1800 g and roomed in with the mother is Kangaroo Mother Care (KMC) superior to a) no
KMC or b) the use of other hypothermia prevention measures/devices?
5. Among healthy neonates, is assessment of weight before discharge from the hospital superior to no assessment of weight?
B. Questions related to care at home
1. Among healthy neonates weighing >1800 g, is daily oral vitamin D supplementation superior to no supplementation?
2. Among healthy neonates weighing >1800 g, is body massage with or without oil superior to no body massage?
3. Among healthy neonates weighing >1800 g, are post-discharge home visits by a healthcare worker superior to no home visits?
4. Among healthy neonates weighing >1800 g, is purposive sunlight exposure superior to no sunlight exposure?
5. Among healthy neonates weighing >1800 g, is bathing with soap superior to bathing without soap?
6. Among healthy neonates weighing >1800 g, is sleeping in the supine position superior to sleeping in a non-supine position (prone
or side or changing positions)?
7. Among healthy neonates weighing >1800 g, is rooming in on the mother’s bed superior to rooming in on a side crib?
Ranking of outcomes
A list of all possible clinically relevant outcomes related to the topics was compiled by the group members. Initially, an online survey
was used to score each identified outcome from 1 to 9. Outcomes scored 7-9 were assigned to be critical, those scored 4-6 were
assigned to be important and those scored 1-3 were assigned to be of low importance. This was combined with the core outcomes in
neonatology as per literature and a suggested list of standard critical and important neonatal outcomes that could be used across all
questions and across all clinical practice guidelines being developed was compiled.
Outcomes of interest
1. For each question, the following outcome was considered critical:
1. Neonatal Mortality (< 7 days, 8 to 28 days)
2. The following outcomes were considered important:
1. Systemic sepsis
2. Rehospitalization for serious systemic infection (pneumonia, diarrhea), feeding inadequacy, or hyperbilirubinemia needing
treatment
3. Moderate and severe hypothermia
4. Exclusive breastfeeding at discharge at six weeks, and at six months of age
5. Physical growth (including weight gain) at 28 days and at six weeks of age
6. Length of hospital stay (days)
3. In addition, relevant critical and important outcomes were added to specific review questions. These include postnatal weight loss,
dehydration, incidence of significant hyperbilirubinemia, maternal satisfaction (questions 1, 2), blood vitamin D levels, duration of
phototherapy (question 3), blindness, conjunctivitis, keratitis (question 6), skin dryness, eczema, dermatitis, skin colonization, trans-
epidermal water loss (question 9), life-threatening events, positional plagiocephaly and hypoxic episodes (question 10).
Literature search
GDGs searched the literature for each question. In the searched literature, first preference was given to recently published (within the
last 2 years) guidelines that have been formulated using the GRADE methodology. If such a guideline document was not available, we
looked for a recently updated systematic review addressing the practice question. If such a systematic review was available, it was used
to prepare the evidence profile. If a systematic review was available but not updated recently, GDGs searched the literature to identify
new studies and updated the meta-analysis. If a systematic review was not available, RCTs found in the literature search were used to
conduct a fresh systematic review. If no RCT was available, observational studies were selected to address the PICO question.
Data abstraction and summary tables of individual studies

A standardized form was used to extract information from relevant studies. Systematically extracted data included:
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study identifiers, setting, design, participants, sample size, intervention or exposure, control or comparison group,
outcome measures, and results. The following quality characteristics were extracted for the RCTs: allocation
concealment, blinding of intervention or observers, loss to follow-up, and intention to treat analysis. The studies
were stratified according to the type of intervention or exposure, study design, birth weight, and gestational age,
where possible. The treatment effect was expressed as relative risks (RR) or odds ratios (OR) for categorical data
and as mean differences (MD) or weighted mean differences (WMD) for continuous data.
Pooled effects
The pooled treatment effect for developing recommendations was considered, wherever feasible. Pooled effects
from published systematic reviews were used if the meta-analysis was appropriately done, and the reviews were up
to date. Where pooling of results was not possible, the range of effect sizes observed in the individual studies was
used in the development of recommendations.
Grading the quality of evidence

Quality assessment of the body of evidence for each outcome was done using the Grading of Recommendations
Assessment, Development, and Evaluation (GRADE) approach.[4] The GRADE approach was used for all the critical
outcomes and a GRADE profile was prepared for each quantitative outcome. Accordingly, the certainty of the
evidence for each outcome was rated as “high”, “moderate”, “low”, or “very low” based on a set of criteria. As a
baseline, RCTs provided “high-certainty” evidence, while non-randomized trials and observational studies provided
“low-certainty” evidence. This baseline quality rating was then downgraded based on consideration of the risk of
bias, inconsistency, imprecision, indirectness, and publication bias.
The following briefly describes how these criteria were used:
Study design: We included only randomized controlled studies. Observational studies and non-randomized
experimental studies were considered for narrative review. Four criteria were used for assessing limitations in the
methods of included studies; 1) Selection bias was assessed by analyzing how randomization and allocation
concealment was done 2) Measurement bias can be minimized by blinding the participants and researchers to the
intervention. If that is not possible, the observers measuring the outcome can be blinded. Measurement bias was
less likely if the outcome is "objective". If most of the evidence was from studies where any of the above was done,
the risk was low, otherwise, it was considered high 3) Loss to follow-up: A large loss to follow-up can lead to bias
in results; 20% loss to follow-up was chosen arbitrarily as the cut- off point. If most of the evidence was from
studies where the loss to follow-up was less than 20%, the risk was low 4) Appropriateness of analysis: If most of
the evidence was from RCTs which had analysis by intention-to-treat the risk of bias was low, else it was high.
Inconsistency of the results: The similarity in the results for a given outcome was assessed by exploring the
magnitude of differences in the direction and size of effects observed from different studies. The quality of
evidence was not downgraded when the directions of the findings were similar and confidence limits overlapped,
whereas quality was downgraded when the results were in different directions and confidence limits showed
minimal overlap.
Indirectness: The quality of evidence was downgraded on serious or very serious concern about the directness of
the evidence, i.e., important differences between the research reported and the context for which the
recommendations are being prepared. Such differences were related, for instance, to populations, interventions,
comparisons, or outcomes.
Imprecision: The degree of uncertainty around the estimate of effect was assessed. As this was often a function of
sample size and number of events, evidence from studies with relatively few participants or events (and thus wide
confidence intervals around effect estimates) were downgraded for imprecision.
Publication bias: Quality rating could also be affected by perceived or statistical evidence of bias that may have led
to underestimation or overestimation of the effect of an intervention because of selective publication based on
study results. Where publication bias was strongly suspected, evidence was downgraded by one level.
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Generation of evidence profiles

Based on studies selected in the previous step, evidence tables were made. Effect size was expressed as relative risk
or odds ratio with their 95% CI for categorical outcomes and weighted mean difference and its 95% CI for
continuous outcomes. Unadjusted outcomes presented as pooled results in the systematic reviews or individual
RCTs were used. If at least one RCT was available, we did not pool the results of the RCT with observational studies
and used the RCT to make the evidence profile. To ensure consistency in the application of downgrading rules,
web-based group discussion sessions were organized and a brief handout ‘Empirical rules for assigning serious and
very serious risks’ was created as a guide. Overall evidence for each outcome was assessed to be of high, moderate,
low, or very low certainty as per GRADE methodology.
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the
estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from
the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially
different from the estimate of effect.
Evidence to Decision (EtD) Framework

Using the GRADE evidence to decision framework, GDGs then answered 10 questions starting from the priority of
problems to the feasibility of implementation.
The questions included:
• Is the problem a priority?

• How substantial are the desirable and undesirable anticipated effects?
• What is the overall certainty (quality) of the evidence of effects – both desirable and undesirable effects?
• Is there important uncertainty about or variability in how much people value the main outcomes?
• Does the balance between the desirable and undesirable effects favor the intervention or the comparison?
• How large are the resource requirements (costs) and what is the certainty (quality) of the evidence of resource
requirements (costs)?
• Does the cost-effectiveness of the intervention favor the intervention or the comparison?
• What would be the impact on health equities?
• Is the intervention acceptable to key stakeholders?
• Is the intervention feasible to implement?
Answers to these questions were based on evidence tables and additional literature to identify the relevant studies
on epidemiology, prognosis, value judgment, resource use, cost-effectiveness, and coverage of the intervention
being evaluated.
Recommendation statements
Based on EtD framework GDGs then wrote the recommendation statement. The recommendation could be of the
following types:
• Strong recommendation for or against the intervention

• Weak recommendation for or against the intervention
• Conditional (context-specific) recommendation for the intervention
Each recommendation was graded as strong when there was confidence that the benefits clearly outweigh the
harms, or weak when the benefits probably outweigh the harms, but there was uncertainty about the trade-offs. A
strong or weak recommendation was further classified as conditional /context specific if the benefits outweigh
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the harms in some situations but not in others.
To ensure that each recommendation is correctly understood and applied in practice, the context of all
recommendations is stated within each recommendation and additional remarks are provided wherever needed.
Users of these guidelines should refer to these remarks, which are presented along with the evidence summaries
within the guidelines.
Document review
Independent reviewers who were not part of the guideline writing or editorial groups reviewed the first draft of the
guidelines document. This was followed by an editorial review. The GDG revised the guidelines based on the review.
The document was finalized by members of the GDG and the editorial team.
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5. Among healthy neonates roomed in with the mother, is lactation support by a

specifically assigned counselor or nurse superior to support by healthcare staff providing
routine medical care?
Breastfeeding is recognized as the most appropriate method of feeding a healthy term and late preterm newborn. The World Health
Organization (WHO) recommends supporting mothers to initiate breastfeeding within the first hour after birth with practical
guidance [3]. Exclusive breastfeeding is the safest, nutritively balanced, universally acceptable, and natural way to support the growth
and development of newborn infants. The benefits exclusive breastfeeding in terms of growth, development, neurosensory maturation,
provision of immuno-nutrients, development of a stable microbiome and the positive impact on metabolic and adult-onset lifestyle
disorders have been well documented [5][6][7]. Breastfeeding also confers numerous health benefits to mothers including risk
reduction of malignancies (breast and ovarian cancer) and cardiometabolic disorders (diabetes mellitus and hypertension) [8][9][10].
The breastfeeding rates vary widely across different countries with a trend towards higher initiation but lower continuation rates in the
developed world[11]. The data from National Family Health Survery-5 (NFHS-5) of India pegged the national average of the early
initiation of breastfeeding at 41.8% and exclusive breastfeeding under 6-month age at 63.7%[12]. An important reason for early
discontinuation of breastfeeding is believed to be the lack of adequate early support and guidance to women after delivery [13][14].
The WHO recommends providing breastfeeding counselling in the antenatal and postnatal periods [3]. Assistance to lactating mothers
may be education-based (e.g., information, demonstration and/or discussion) or support-based (e.g., counselling, consultation or social
support). Support to breastfeeding mothers by counselling and consultation is grounded in the breastfeeding self-efficacy
(BSE) [15][16] theory where the mother's self-belief in breastfeeding helps her overcome difficulties and challenges encountered
during breastfeeding and helps her in initiating and maintaining lactation. The perceived insufficiency of breast milk, low self-efficacy,
young age, low family income, less education and migrant status are some of the risk factors for not starting or early interruption of
breastfeeding. With these considerations it is imperative from a public health perspective and also for providing guidance to health
care workers in maternity and child services, to know whether provision of counsellor whose main responsibility is providing lactation
support to postpartum mothers in the hospital has a lasting impact on the initiation, short-term or long-term continuation of
breastfeeding.
Mothers of term and late preterm neonates should be provided lactation support by a counselor or nurse whose sole or main
responsibility is lactation counseling. This support should be provided at the time of delivery and during the hospital stay after
childbirth.
Evidence to decision
Benefits and harms Substantial net benefits of the recommended alternative
Important benefits of lactation support after birth would be early initiation of breastfeeding, lesser use of formula milk during
birth hospitalization and a higher incidence of exclusive breastfeeding at discharge from hospital. This would translate into a
longer duration of exclusive or any breastfeeding. Also, since the benefits of breastfeeding have a dose-response relationship
and are different with exclusively breastfeeding versus mixed feeding, [17]it is important to examine the duration of both
exclusive breastfeeding and any breastfeeding. Although, the risk factors of opting not to breastfeed or discontinuing in early
infancy may differ from those of discontinuing breastfeeding later in infancy, we looked at the effect of lactation support on
both early and late interruption of breastfeeding. Early interruption of breastfeeding can be due to perceived insufficiency of
milk, giving birth to a low-birth-weight baby, social pressures or taboos, experiencing breastfeeding problems, and low BSE,
while late interruption can be due to financial and work pressures. This outcome of interest has been reported in studies as
‘stopping of breastfeeding’. Different studies have reported breastfeeding cessation by 6 weeks, 3 months, 6 months, or 12
months[18]. A total of 43 RCTs reported the effect of lactation support on stopping exclusive breastfeeding while 36 RCTs
16 of 103
reported the effect on stopping of any breastfeeding. In these studies, lactation support was provided by a lactation
consultant, lactation consultant with electronic prompts, trained community health workers or peer supporters with some
training. The lactation support was provided as face-to-face support, telephonic support, in-hospital support or home-visits
during the prenatal, perinatal or postnatal period. Serious inconsistency between the studies resulted in evidence of moderate
certainty. Lactation support resulted in 52 to 124 fewer mothers stopping exclusive breastfeeding and 9 to 65 fewer mothers
stopping any breastfeeding at 4-6 weeks of age. Significant beneficial effect was also noted at 3 to 4 months of age with 110
to 168 fewer mothers stopping exclusive breastfeeding and 32 to 88 fewer mothers stopping any breastfeeding if provided
lactation support. At 6 months, 59 to 102 fewer mothers stopped exclusive breastfeeding and 18 to 66 fewer mothers stopped
any breastfeeding [18].
Inadequate breastfeeding guidance and support may result in an exaggeration of the postnatal weight loss experienced by
newborns because of underfeeding. This may progress to dehydration and jaundice. Thus, the other outcomes of interest are
morbidities believed to be associated with breastfeeding reported as independent outcomes or composite of related
outcomes e.g., ‘jaundice, dehydration and weight loss.’ Jaundice, dehydration, or weight loss as a composite outcome has been
reported by 2 RCTs, with both studies having a serious risk of bias due to lack of blinding of the outcomes assessment.
Moderate certainty evidence showed no reduction in this outcome with breastfeeding support[19][20].
Since breastfeeding reduces the risk of acute respiratory infections and gastroenteritis, we also examined the effect of lactation
support on the incidence of hospitalization during the first 3 to 6 months of age. A total of eight RCTs reported hospitalization
during the first 3 months of age[21][22][23][24][25][26][27][28]. These studies had a high risk of bias due to non-blinding
of intervention and outcome measurement. The absolute effect does not favor either breastfeeding support or usual care.
Certainty of the Evidence Moderate
A moderate certainty evidence was available demonstrating the benefit of lactation support on the duration of exclusive and
any breastfeeding till 6 months of age. Moderate certainty evidence showed no effect on neonatal morbidities associated with
suboptimal breastmilk intake (jaundice, dehydration, or weight loss). Low certainty evidence showed on effect on the incidence
of hospitalization within 3 months of age.
Values and preferences Substantial variability is expected or uncertain
Breastfeeding the newborn after birth is seen in some societies, especially in the Western world, as a personal choice of the
mother. In other parts of the world the decision to breastfeed and continue for a longer duration is dictated by multiple factors
including family support especially from the husband and in-laws, and the need to return to work/office[29][30]. Mothers
expect the healthcare worker to have the knowledge and skills necessary to provide breastfeeding guidance, but also report
that the encouragement and advise received is mostly superficial and inadequate[31]. Mothers' perception of a neutral
attitude of the hospital staff or advise by a healthcare worker to formula-feed the newborn lead to earlier cessation of
breastfeeding. Mothers experiencing latching and nipple issues were more likely to discontinue feeding. Mothers value praise,
encouragement, accurate information, observation of the baby's breastfeeding behavior, diagnosis of the problem and
solution from the healthcare provider rather than just answers to the mothers' questions, receiving written information or
referral to a lactation consultant[32][33]. From the healthcare workers perspective, studies have found that interns and
residents in Pediatrics were more likely to encourage breastfeeding[34]. Pediatricians showing interest in the infant feeding
plan positively impacted breastfeeding while pediatricians who were ambivalent created a negative impact on the mothers
breastfeeding[35]. Nurses, especially those with personal breastfeeding experience, have been reported to have influence on
early initiation and duration of breastfeeding[35]. Healthcare providers believe that optimal breastfeeding support includes
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answering questions posed by mothers, providing written information and referring to a lactation counselor [36].
Resources No important issues with the recommended alternative
There is limited evidence on the resource use and cost-effectiveness of strategies to promote or support breastfeeding.
Promoting breastfeeding results in lesser infectious morbidity, lesser hospitalization rates, and lower infant and child mortality.
In a study, the cost burden of not breastfeeding was estimated to be 0.5% of the World’s gross domestic product (GDP). Thus,
supporting breastfeeding is likely to be a cost-effective option[35] [38][39][40][41] [42].
Equity No important issues with the recommended alternative
The impact of breastfeeding on health equity is unquestionable. There is a positive impact of support
provided to breastfeeding mothers in terms of initiation and continuation [18].
Acceptability No important issues with the recommended alternative
No major concerns are anticipated in mothers' acceptance of breastfeeding support through healthcare workers in institutional
or community settings. [43].
Feasibility No important issues with the recommended alternative
Starting breastfeeding support services in institutional settings is imminently feasible by training healthcare professionals such
as doctors (pediatrician, obstetrician), nurses and lactation counselors and allowing them to function in a dedicated capacity
for providing these services. Institutions must provide adequate impetus and support in facilitating training of these healthcare
professionals and may even incentivize this. Training and capacity building would be required to roll-out these services
successfully. Recently mobile phone-based platforms have been shown to feasible and acceptable through breastfeeding
counselors [43]
Clinical question/ PICO
Population: Term healthy neonates

Intervention: Breastfeeding support
Comparator: No breastfeeding support
Certainty of
Intervention
Outcome Study results and Comparator the Evidence
breastfeeding Summary
Timeframe measurements routine care (Quality of
support
evidence)
Relative risk 0.88

Stopping any
(CI 95% 0.79 — 0.97)
308 271 Moderate
Breastfeeding support
probably decreases
breastfeeding at per 1000 per 1000 Due to serious
Based on data from 1 stopping any
4-6 weeks 11,413 participants in 36 inconsistency breastfeeding at 4-6
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Certainty of
Intervention
support
evidence)
Difference: 37 fewer per

studies. (Randomized 1000
weeks
9 Critical controlled) ( CI 95% 65 fewer
— 9 fewer )
Stopping any Relative risk 0.87 462 402

per 1000 per 1000 Breastfeeding support
breastfeeding at (CI 95% 0.81 — 0.93)
Moderate probably decreases
Based on data from
3-4 months Due to serious stopping any
12,054 participants in 32 Difference: 60 fewer per 2
1000 inconsistency breastfeeding at 3-4
studies. (Randomized
8 Critical months
controlled) ( CI 95% 88 fewer
— 32 fewer )
Stopping
Relative risk 0.81 731 592
exclusive (CI 95% 0.77 — 0.85) per 1000 per 1000 Breastfeeding support
breastfeeding at Moderate probably decreases
Based on data from
Due to serious stopping exclusive
3-4 months 11,575 participants in 43 Difference: 139 fewer per 3
months
— 110 fewer )
Stopping any Relative risk 0.93 600 558

per 1000 per 1000 Breastfeeding support
breastfeeding at (CI 95% 0.89 — 0.97)
Moderate probably decreases
Based on data from
6 months Due to serious stopping any
14,610 participants in 30 Difference: 42 fewer per 4
1000 inconsistency breastfeeding at 6
7 Critical months
— 18 fewer )
Stopping 891 846

Relative risk 0.95
per 1000 per 1000 Low
breastfeeding at (CI 95% 0.9 — 1) Due to serious risk
12 months may decrease stopping
Based on data from 1,311 of bias, Due to
Difference: 45 fewer per breastfeeding at 12
participants in 2 studies. serious
1000 5 months slightly
6 Important (Randomized controlled) ( CI 95% 89 fewer imprecision
— 0 more )
Stopping
exclusive (CI 95% 0.76 — 0.9) per 1000 per 1000 Breastfeeding support
breastfeeding at Moderate probably decreases
Based on data from
Due to serious stopping exclusive
4-6 weeks 14,544 participants in 42 Difference: 88 fewer per 6
weeks
— 52 fewer )
Relative risk 0.9

Stopping
(CI 95% 0.88 — 0.93)
847 762 Moderate
probably decreases
exclusive per 1000 per 1000 Due to serious
Based on data from 7 stopping exclusive
breastfeeding at 16,332 participants in 40 inconsistency breastfeeding at 6
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Certainty of
Intervention
support
evidence)
6 months Difference: 85 fewer per

studies. (Randomized 1000
months
7 Critical
— 59 fewer )
Hospital
readmission in Odds ratio 0.95
125 120 Breastfeeding support
(CI 95% 0.82 — 1.09) per 1000 per 1000 Moderate
3-month probably has little or no
Based on data from 9,058 Due to serious risk difference on hospital
postnatal age Difference: 5 fewer per 1000
participants in 8 studies. of bias
8 readmission in 3-month
(Randomized controlled) ( CI 95% 20 fewer postnatal age
6 Important — 10 more )
Jaundice, 110 99
Relative risk 0.9
dehydration and per 1000 per 1000 Breastfeeding support
(CI 95% 0.76 — 1.05) Moderate
weight loss probably decreases
Based on data from 4,402 Due to serious risk
Difference: 11 fewer per jaundice, dehydration and
participants in 2 studies. of bias
9
1000 weight loss
6 Important (Randomized controlled) ( CI 95% 26 fewer
— 5 more )
1. Inconsistency: serious. Downgraded one level for inconsistency. Evidence of unexplained heterogeneity..
Indirectness: no serious. Imprecision: no serious. Publication bias: no serious.
5. Risk of Bias: serious. Downgraded 1 level due to serious risk of bias. High or unclear risk of bias in both
studies.. Inconsistency: no serious. Indirectness: no serious. Imprecision: serious. Downgraded 1 level for
serious imprecision. Small sample size. 95% CI overlaps the line of no effect.. Publication bias: no serious.
8. Risk of Bias: serious. Chapman 2004, Laliberte 2016, Nair 2017, Nilsson 2017, Patel 2018, Petrova 2009,
Bunik 2010: High risk of bias as blinding of outcome assessment was not done. Laliberte 2016, Nair 2017,
Nilsson 2017, Patel 2018, Petrova 2009, Bunik 2010: Unblinded study.. Inconsistency: no serious.
9. Risk of Bias: serious. Bashour 2008, Nilsson 2017: High risk of bias as blinding of outcome assessment
was not done. Nilsson 2017: Unblinded study.. Inconsistency: no serious. Indirectness: no serious.
Imprecision: no serious. Publication bias: no serious.
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6. Among healthy neonates, is assessment of weight before discharge from the hospital
superior to no assessment of weight?
Newborn infants experience a physiologic weight loss following birth, arising largely from the contraction of the proportionately larger
extracellular fluid compartment and the establishment of postnatal renal perfusion and consequent diuresis[44]. Term low birth weight
infants show lesser weight loss compared to newborns with a normal birth weight[45]. Weight loss is most evident in the first 3-4 days
and a cumulative weight loss of up to 7% is considered acceptable in term infants[46]. Following early initiation of breastfeeding after
birth, it can take 48-72 hours before mothers experience adequate lactation, which coincides with the period of maximal postnatal
weight loss experienced by the newborn[47]. Even though this entire process is physiological, the relevance and validity of the
acceptable weight loss of 7% is increasingly being questioned [48]. It can lead to maternal anxiety, interruption of exclusive
breastfeeding, and supplementation with formula milk. The exaggeration of this physiological process due to various reasons is seen in
a small subset of newborns resulting in serious hyperbilirubinemia, hypernatremia, and dehydration, necessitating readmission with
disastrous neurodevelopmental consequences and risk of mortality[49]. The preventable nature of these morbidities makes it
imperative to identify a strategy for identifying neonates experiencing excessive weight loss. In this regard, several newborn discharge
preparation and readiness tools have been developed, and guidelines from professional bodies have been promulgated. With these
considerations, we examined the role of pre-discharge weighing of healthy term neonates for identifying those at risk of these
preventable morbidities.
Weak recommendation , Low certainty evidence
Neonates may be weighed prior to discharge from the hospital to identify those with excessive weight loss. Early discharge may be
deferred in neonates showing weight loss ≥8% or examined by a healthcare worker within 48-72 hours of discharge.
Benefits and harms Small net benefit, or little difference between alternatives
Weighing a neonate prior to discharge after birth in a health facility is a common practice [50][51][52][53]. Meticulous
recording of birth weight and re-confirming it has been recommended by professional bodies. During the postnatal
hospitalization period, checking the neonate's weight daily is discouraged as the physiological weight loss in the baby may
cause anxiety in the mother and increased use of supplemental milk feeding [56]. However, pre-discharge examination and
screening of the term healthy newborn, including checking the pre-discharge weight, is recommended as a guideline or a
policy document by pediatric and neonatal professional societies and adopted in different manners in institutions providing
maternal and neonatal care [50][51][52][53][54][55][56]. The benefits of pre-discharge weighing would be to identify a
small subset of neonates who have experienced excessive weight loss, are dehydrated, and are therefore at risk for
hypernatremia, significant hyperbilirubinemia, and the need for readmission. The harms arising from pre-discharge weighing
lie in the maternal perception of inadequacy resulting in the initiation of supplemental formula milk feeding.
On the converse, identifying a neonate at the border of acceptable weight loss on the day of discharge may prompt healthcare
personnel to provide supplemental formula milk on their own or on parental request. It may create anxiety in the parents
which may adversely affect maternal milk production and delay discharge.
Certainty of the Evidence Low
We did not find any clinical trial that evaluated the utility of pre-discharge weighing in healthy term or late preterm neonates.
The feasibility of conducting a clinical trial comparing newborns who were weighed prior to discharge vs those not weighed
prior to discharge for outcomes such as postnatal weight loss and dehydration is less likely since the intervention in question is
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not resource intense, is low cost and ingrained in the postnatal care protocols. However, studies have reported the extent of
weight loss, the incidence of ‘excessive’ weight loss, and the comparison of weight loss in vaginal and caesarian births.
Overall, 10 observational studies (6163 participants) reported expected/acceptable weight loss (≤ 8%) and excessive weight
loss (> 8%) in exclusively breastfed neonates [48][49][57][58][59][60][61][62][63][64]. The incidence of excessive weight
loss reported in these studies varied from 21% to 58%. Five studies (3,43,931 participants) compared postnatal weight loss in
neonates born by vaginal delivery and caesarian section [65][66][67][68][69]. The incidence of excessive weight loss in
breastfed neonates varied from 6.5% to 25%. The certainty of evidence from these 15 studies was graded as low due to a
serious risk of bias.
Of these 10 observational studies, four studied the outcome ‘stopping of exclusive breastfeeding’ [48][49][57][58]. Thulier et
al reported a drop in exclusive breastfeeding to mixed feeding or formula feeding from 90% to 53% due to excessive postnatal
weight loss [48]. Other studies have quoted similar exclusive breastfeeding cessation rates. The certainty of evidence from
these 4 observational studies on stopping breastfeeding is graded low due to serious risk of bias.
There are no studies which have evaluated effect of pre-discharge weighing vs no weighing on neonatal jaundice as an
outcome in healthy term or late preterm neonates. However, there are eleven studies (3 RCTs and 8 observational studies)
which reported the incidence of jaundice requiring readmission and management in relation to breastfeeding, mixed/formula
feeding and postnatal weight loss. In five of these studies, jaundice requiring readmission was evaluated in relation to
expected/ acceptable weight loss (≤ 8%) versus excessive weight loss (> 8%) in exclusively breastfed neonates or neonates on
mixed/ formula feeds [57][60][63][70][71]. In three observational studies, the effect of early supplemental formula in
preventing/ reducing the risk of jaundice, risk factors for jaundice in exclusively breastfed neonates, and the effect of
breastfeeding frequency in reducing/ preventing jaundice was studied. The 3 RCTs reporting neonatal
jaundice[72][73][74] were part of a Cochrane systematic review on ‘Early postnatal discharge from hospital for healthy
mothers and term infants’[75]. Pre-discharge weighing resulted in 59 more newborns per 1000 requiring therapy for neonatal
jaundice [RR 1.59 (95%CI 1.11 - 2.30)]. The certainty of evidence from these studies was graded low owing to the serious
indirectness and imprecision due to small sample size.
There are several publications on pre-discharge weighing of neonates: recommendations[50], position statement[51], policy
statement [52], clinical protocol [53], clinical guidelines [54][55][56], and WHO guidance on weighing of newborns[76]. It
has been recommended by the Spanish Association of Pediatrics to assess the weight, hydration and nutritional status of the
newborn prior to discharge, especially in exclusively breastfed newborns or those delivered by caesarean section (Grade of
recommendation B) [50]. The position statement of the Canadian Pediatric Society on Facilitating discharge from hospital of
the healthy term infant in the discharge readiness checklist requires the weight loss to be below 10%. If the weight loss is close
to 10% or greater a follow-up plan is required to be arranged[51]. The American Academy of Pediatrics (AAP) policy statement
requires a risk assessment for readmission, a physical examination and assessment of physiological stability to be done. In
newborns being discharged to home within 48 hours of birth, an assessment by a healthcare practitioner within 48 hours of
discharge is mandated [52]. The Academy of Breastfeeding Medicine clinical protocol recommends provision of supplemental
feeds if concern of weight loss is present (level of evidence 1, 2; strength of recommendation A) [53]. Clinical guidelines
discussing discharge preparation of the newborn exhort the importance of assessment of the hydration status of the newborn
and plotting the growth parameters in the anthropometric charts [54][55][56].
Values and preferences No substantial variability expected
Pre-discharge weighing of the newborn may be seen as an important part of the discharge work-up by both parents and
healthcare providers [49][50]. It would provide an objective assessment of the newborn on follow-up. Change in weight from
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the birth weight is a physiological postnatal adaptation but an assessment of weight change at follow-up would be indicative
of postnatal stability and successful establishment of breastfeeding. This may not be possible if there is no information on pre-
discharge weight available on follow-up. For the parents' information on the pre-discharge weight may help in reaffirming
their decision to comply with follow-up.
Resources Important issues, or potential issues not investigated
There is no direct evidence comparing resource use with and without pre-discharge weighing. However, recent studies have
shown that early discharge in term and late preterm neonate’s results in an increase in readmission and thus, an increased cost
of health care due to physician costs, emergency department costs and hospitalization costs with no net cost savings which is
perhaps likely when neonates are discharged without weighing [78]. Early discharge in term infants imposes additional
resource requirements due to increased readmission for neonatal jaundice and infections [79] which is likely to be the case
with discharging neonates without weighing them and making an assessment about the degree of weight loss and hydration
status.
Equity Important issues, or potential issues not investigated
There are no evident health equity concerns related to pre-discharge weight assessment in healthy term and late preterm
newborns. The equipment required, time taken, and expertise required is minimal and ubiquitously available in healthcare
settings.
Acceptability Important issues, or potential issues not investigated
No evidence is available about acceptability of pre-discharge weight assessment. However, it is unlikely that pre-discharge
weighing will not be acceptable to healthcare providers and parents.
Feasibility Important issues, or potential issues not investigated
Pre-discharge weighing of healthy term neonates is a feasible intervention. There is no anticipated difficulty in weighing
newborns prior to discharge and recording that weight for assessment during the follow-up visit.
Population: Term healthy neonates

Intervention: Pre-discharge weighing
Comparator: No pre-discharge weighing
Comparator Certainty of
Intervention
Outcome Study results and No pre- the Evidence
Pre-discharge Summary
Timeframe measurements discharge (Quality of
weighing
weighing evidence)
Jaundice
requiring
Relative risk 1.59
(CI 95% 1.11 — 2.3)
100 159 Low
Due to serious
There are no direct
studies comparing pre-
23 of 103
Intervention
weighing
weighing evidence)
per 1000 per 1000 discharge weighing vs. no

weighing in healthy term
Difference: 59 more per 1000 and late preterm
( CI 95% 11 more newborns. However,
— 130 more ) there are 3 RCTs in the
CDSR on 'Early postnatal
discharge from hospital
for healthy mothers and
term infants' (Jones 2021)
which have evaluated the
treatment outcome 'readmission
Based on data from 1,041 indirectness, Due
and treatment for
participants in 3 studies. to serious
1 neonatal jaundice' in
(Randomized controlled) imprecision
neonates discharged
early (within 24 hours) vs
late (typically after 72
hours). The CoE has been
downgraded due to
serious indirectness and
small sample size. Pre-
discharge weighing
probably increases
jaundice requiring
treatment slightly.
There are no clinical trials in term Overall, 10 observational

healthy neonates comparing pre- studies (6163
discharge weighing vs. no weighing at participants) reported
discharge. There are 10 observational expected/acceptable
studies comparing expected/ weight loss (≤8%) and
acceptable weight loss (≤ 8%) vs. excessive weight loss
excessive weight loss (> 8%) in (>8%) in exclusively
exclusively breastfed neonates (Thulier breastfed neonates
2016; Verd 2018; DiTomaso 2017; [47][48][56][57][58][59][60][61][62][63].
Grossman 2012; Bertini 2014; The incidence of
Fonseca 2014; Mezzacappa 2015; excessive weight loss
reported in these studies
Mulder 2010; Davanzo 2012;
was 96/165, 58% [47];
Crossland 2007). There are 5 studies
165/788, 21% [48]; 84/
Postnatal weight which have compared postnatal Moderate 151, 56% [56]; 24/121,
loss and Based on data from weight loss in neonates delivered Serious risk of 19.8% [57]; 385/1270,
343,931 participants in 15 vaginally vs. caesarian section bias; However CoE 30.3% [58]; 130/1288,
dehydration
studies. (Observational (Flaherman 2014; Flaherman 2017; upgraded one 10.1% [59]; 11/53, 20.8%
(non-randomized)) Hamilcikan 2017; Paul 2016; Preer level due to the [60]; 107/414, 25.8% [61]
7 Critical 2 and 272/1003, 27.1% [62].
2012). large sample size
Five studies (3,43,931
participants) compared
postnatal weight loss in
neonates born by vaginal
delivery and caesarian
section
[64][65][66][67][68]. The
incidence of excessive
weight loss in breastfed
neonates was 48085/
192340, 25% [64]; 7129/
33160, 21.5% [65]; 0/
1428, 0% [66]; and 13/
200, 6.5% [68]. The
24 of 103
Intervention
weighing
weighing evidence)
certainty of evidence
from these 15 studies was
graded as low due to a
serious risk of bias. Pre-
discharge weighing
probably improves
postnatal weight loss and
dehydration
There are no studies comparing routine There are 4 observational

pre-discharge weighing vs.no weighing studies with 1346
head-to-head. However, there are 10 participants which have
studies comparing postnatal expected/ studied the outcome
acceptable weight loss taken variously 'Stopping of
as ≤ 8% compared with excessive breastfeeding'. Thulier et
weight loss taken as > 8% in healthy al reported
exclusively breastfed term neonates. discontinuation of
Only 4 out of these 10 studies have breastfeeding in 83/165
reported on stopping of breastfeeding (53%) of exclusively
in the two groups (Thulier 2016; Verd breastfed newborns with
2018; DiTomaso 2017; Grossmann >7% weight loss by day-4
Stopping of
2012). postnatal age. Verd et al
exclusive Low
Based on data from 1,346 reported 504/788 (64%)
breastfeeding Observational
participants in 4 studies. breastfeeding
Day-4 to day-100 studies; Small
discontinuation rate in
postnatal age (Observational (non- sample size, Due
newborns with >7%
randomized)) to serious risk of
3 weight loss by day-100.
bias DiTomaso reported 24/84
8 Critical
(33%) exclusive
breastfeeding
discontinuation by
day-14 age and in the
study by Grossman by
day-7 age in 66/121
(54.5%) newborns
exclusive breastfeeding
had been discontinued.
Pre-discharge weighing
may improve stopping of
exclusive breastfeeding
1. Inconsistency: no serious. Indirectness: serious. The 3 RCTs compared early maternal and neonatal
discharge from hospital (within 24 hours) with later discharge (typically after 72 hours) for maternal and
neonatal outcomes.. Imprecision: serious. Low number of patients,. Publication bias: no serious.
2. Risk of Bias: serious. Observational studies, Inadequate sequence generation/ generation of comparable
groups, resulting in potential for selection bias, Inadequate concealment of allocation during randomization
process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel,
resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in
potential for detection bias, Missing intention-to-treat analysis. Inconsistency: no serious. Indirectness: no
serious. Direct comparisons not available. Imprecision: no serious. Publication bias: no serious. Upgrade:
large magnitude of effect.
3. Risk of Bias: serious. Observational studies, Inadequate sequence generation/ generation of comparable
groups, resulting in potential for selection bias, Inadequate concealment of allocation during randomization
process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel,
25 of 103
resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in
potential for detection bias, Missing intention-to-treat analysis. Inconsistency: no serious. Indirectness: no
serious. Direct comparisons not available. Imprecision: no serious. Publication bias: no serious. Upgrade:
clear dose-response gradient.
26 of 103
7. Among healthy neonates weighing >1800 g, is daily oral vitamin D supplementation

superior to no supplementation?
Vitamin D deficiency is an important public health problem in India. Prevalence of Vitamin D deficiency (VDD)
among pregnant women (majority of studies used a cut off of 20 ng/mL) in India has been estimated to be 32.3% (95% CI,
12.6 to 117.5)[80] Since the developing fetus cannot synthesize Vitamin D, it is dependent on the transplacental
passage from the mothers' stores. After birth, during first 6 months the only dietary source of vitamin D for the
infant is mothers' milk. The concentration of vitamin D in human milk has been estimated to be 20-50 IU/
L.[81] Thus, breast milk alone may not be an adequate source of vitamin D for breastfed neonates. The prevalence
of VDD among neonates and young infants at the population level is not known. The Comprehensive National
Nutrition Survey (CNNS) undertaken by the Ministry of Health and Family welfare (2016-2018) estimated the
prevalence of VDD among children in the age group 1 to 4 years and 5 to 9 years as 14% and 18%
respectively.[82] A study from southern India estimated that nearly 92% of the full-term newborns had VDD at
36-48 hours of life.[83] Another study from north India estimated VDD among neonates and infants (n=200)
suggested that 74% of the infants had VDD. Clinical signs of rickets were present in 20-50% of the infants while
27% neonates with VDD presented with hypocalcemia. Exclusive breast feeding and low maternal vitamin D levels
were found to be important risk factors for VDD in infants.[84]
Vitamin D is not only important for bone health (prevention of osteomalacia, fractures, rickets and subsequent bony
deformities) but also has a role in immune regulation, atopic eczema, and allergic diseases.[85] Rickets and bony
deformities secondary to vitamin D deficiency are widely prevalent in MICs like India. Observational studies suggest
a high prevalence of VDD (66.7%) among healthy breast-fed term infants at 3 months of age, nearly 1/3rd of infants
with Vitamin D levels <10 ng/mL had radiological rickets.[86] A case series of 20 exclusively breastfed infants who
developed rickets at postnatal age range of 3 months to 15 months underscores the importance of subclinical
vitamin D deficiency in the mother and neonates.[87] Overcrowding in urban areas, lack of sunlight exposure
compounded by atmospheric pollution, maternal malnourishment and cultural beliefs, such as pardah and
vegetarianism, may be contributing to this burden of VDD and rickets, despite India having ample sunlight
throughout the year.[88] It is also noteworthy that despite the availability of ample sunlight and the geographic
advantage, VDD has been reported in nearly 70-100% of adult population cohorts in India.
However, the WHO does not recommend ‘routine’ Vitamin D supplementation to all healthy term newborns.[3] This
is in contrast with the policy statements from other organizations such as AAP[89], CPS[90], and IAP[81], which
suggest supplementing Vitamin D to all neonates.
Daily oral vitamin D supplements (400 IU/day) for 3-6 months should be administered to term breastfed neonates and infants to
prevent vitamin D deficiency.
Research evidence
We reviewed the recent WHO guidelines (2021) based on a cochrane review published in 2020 which had included 8
randomised trials for the comparison of ‘Vitamin D supplementation’ vs ‘no supplementation or Placebo’. We updated the
th st
search strategy from 30 May,2020 to 31 December, 2022. We identified 2 new randomized trials and included 10 studies
enrolling 528 neonates. Majority of the studies were from high income countries (3 from USA, 1 each from Australia, Mexico,
Spain, Thailand and Taiwan). One study from Norway included immigrant mothers and neonates from Pakistan, Somalia and
27 of 103
Turkey. Only one study form India was from a MIC country. Age at enrolment varied from birth to 2 months of age. Majority of
the studies used a dose of 400 IU/day and the duration of supplementation varied from 3 months to 12 months.Critical
outcomes for the review were effect on bone health (incidence of Rickets, bone mineral density) which did
not differ between the intervention and control groups. None of the infants developed rickets in the
included studies. Only one study[91] measured bone density and did not find any difference while two
studies[92][93] looked at the bone mineral content and did not find any difference. . The lack of effect of vitamin
D supplementation on bone health has been ascribed to the inclusion of healthy mothers with adequate vitamin D stores or
exclusion of mother/infant dyads due to vitamin D deficiency in the mother or the neonate (if an early estimation of vitamin D
was performed before the intervention).
Important desirable effects which showed improvement were incidence of (<30 nmol/L) & insufficiency (<50
nmol/L) at 3- 6 months of age, vitamin D levels at 6 months, and weight at the latest measured time. Four randomized
trials[94][95][96][91] reported on incidence of vitamin D deficiency- 112 to 255 fewer patients had vitamin D
deficiency when given vitamin D in comparison to placebo. Similarly, 189 to 346 fewer infants had vitamin D insufficiency
among infants from the 6 trials. [97][94][95][98][96][91] The certainty of evidence for benefit in both VDD and insufficiency
was moderate.
Weight at the latest time measured in follow-up was a higher- mean difference 247.63 g (95% CI, 29.59 to 465.67) in the
infants exposed to vitamin D, however, the certainty of evidence was very low.
Important harms of vitamin D supplementation included signs of vitamin D toxicity including hypercalcemia. Out of the two
studies that reported this outcome, one study did not find any event [91]; and the other study showed transiently raised
calcium levels which resolved on their own. The incidence of hypercalcemia in both intervention and control groups was
similar [95] There were no other major adverse effects noted due to Vitamin D supplementation. None of the studies looked
at infectious morbidities and infant mortality. One study looked at allergic outcomes (eczema, allergic rhinitis and food allergy)
at 1 and 2.5 years of age and found no difference between those given vitamin D and those administered placebo.
Additional considerations
It is impractical in our setting to measure the vitamin D status of every mother and neonate at the time of birth to determine
which neonate is at risk of vitamin D deficiency. A healthy mother can also harbor undetected VDD which may lead to
inadequate stores in her term neonate.
Summary
The balance of benefits and harms favors vitamin D supplementation. Although there were no important benefits in the critical
outcomes, the incidence of vitamin D deficiency was markedly less in the intervention groups. A longer period for follow-up,
beyond 6 months of age, may have unmasked cases of rickets as the most common age group for presentation of rickets is
between 1 and 4 years of age.
Research evidence
Overall certainty of evidence for critical outcomes of nutritional rickets, bone mineral content at the end of
intervention was low. There was moderate certainty evidence that vitamin D administration leads to a
decreased incidence of Vitamin D deficiency and Vitamin D insufficiency after 3- 6 months of intervention.
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Research evidence
A qualitative evidence synthesis of thirty-six studies (mostly from high-income countries) on postnatal care experiences of
pregnant women showed that women tend to prioritize the needs of their infant (low confidence in the evidence) and,
appreciate practical advice, support and information from health workers (moderate confidence in the evidence), provided this
is delivered in a consistent manner and in a form they can understand (moderate confidence in the evidence).[99]
There are no studies showing how much value the health care professionals, parents, and policymakers would place on the
surrogate outcome of vitamin D deficiency and vitamin D insufficiency when compared with rickets, bone deformities, and
bone mineral density.
Research evidence
No economic evaluations of vitamin D supplementation for breastfed, term infants were identified
A cost-effectiveness modeling study of the use of vitamin D supplementation in pregnant women and infants and children < 4
years of age in the United Kingdom, where rickets has an estimated annual incidence of 29.75 per 100,000 children < 4 years of
age, found that vitamin D supplementation in dark skin tone populations was cost saving [100] IIn medium skin tone
populations and light skin tone populations, the incremental cost-effectiveness ratio was £19 295 per QALY and £404 047 per
QALY, respectively. Overall, supplementation was cost-saving in participants with a dark skin tone, cost-effective in participants
with a medium skin tone, but not cost-effective in participants with a light skin tone.
Although there have been no cost-effectiveness studies of Vitamin D supplementation in neonates and infants from India, a
recent study looked at the different vitamin D formulations available in the Indian scenarioo.[101] They found a
disproportionate increase in the number of brands and cost variation in cholecalciferol and calcitriol products from 2013 to
2020. It should be noted that vitamin D has been included in the National List of Essential Medicines (NLEM) in
India[102] Vitamin D formulations are available to the patients with no out of pocket expenditure (OOPE)
government hospitals.
Summary
No economic evaluations of vitamin D supplementation for breastfed, term infants were identified
In the absence of free or subsidized government supply, a large proportion of families belonging to lower
economic groups may not be able to afford the cumulative cost of vitamin D supplementation over the first
6-12 months of age.
Summary
Lower economic groups may find it difficult to procure vitamin D in absence of govenment supply of
medicines
Research evidence
In a study from north India, median (IQR) compliance to routine vitamin D supplementation was 66.7% (50%, 83.3%). However,
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the study also reported a low level of reinforcement from healthcare workers. Further, only about a third of parents were aware
of the need for supplementation[104]
It is unlikely that if made aware of the justification of routine supplementation, parents or healthcare professionals would
accept the risk of having rickets and bony deformities compared to the low cost and ease of administration[105]
Summary
Administering Vitamin D to healthy breastfed term neonates should be acceptable to all stakeholders
Vitamin D supplementation is feasible as it does not require any additional resources or trained personnel for administration.
From a public health policy perspective, Vitamin D supplementation to all infants would carry a significant cost to society/
government. Vitamin D is included in the National List of Essential Medicine (NLEM[102] and the ceiling costs can be
controlled by National Pharmaceutical Pricing Authority (NPPA).
Summary
Vitamin D supplementation is feasible in Indian setting considering the moderate certainty evidence for benefit in important
outcomes and inability to exclude harms (rickets/bony deformities) if supplementation is not given.
Rationale
We are uncertain about the effect of routine Vitamin D supplementation among term infants on critical outcomes of Rickets and
bone mineral density. However, there is moderate certainty evidence that it will reduce incidence of vitamin D deficiency and
vitamin D insufficiency
The intervention would incur no to minimal additional health-care costs (considering that the medicine is being provided by the
government), no increase in manpower needs and no specific training requirements for health care personnel. However, no special
resource is required. Overall, it is a feasible intervention that can be implemented. Considering the magnitude of the problem in
question - Rickets and fractures in toddlers and childhood; intervention would be acceptable to all stakeholders due to its putative
benefits. However, the effect of the proposed intervention on critical outcomes are not clear.
Hence, we propose a strong recommendation in favor of the intervention to prevent vitamin D deficiency, until further evidence is
available.
Population: Term breastfed infants

Intervention: Vitamin D supplementation
Comparator: Placebo OR No supplementation
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Outcome Study results and Placebo OR No Intervention the Evidence
Summary
Timeframe measurements supplementatio Vitamin D (Quality of
n evidence)
Nutritional Relative risk 0 0 Low Vitamin D

Rickets Due to serious supplementation may not
per 1000 per 1000
3-6 months Based on data from 193 indirectness, Due have any effect on the
1 to serious
participants in 4 studies. CI 95% 0 fewer — incidence of Rickets in
2 young infants
9 Critical (Randomized controlled) imprecision
Vitamin D
insufficiency:
525 247
Relative risk 0.47 per 1000 per 1000 Vitamin D
25-OH vitamin D (CI 95% 0.34 — 0.64) Moderate supplementation may
3
< 50 nmol/L Based on data from 433 Difference: 278 fewer per Due to serious decrease the incidence of
3 to 6 months participants in 6 studies.
4
1000 indirectness
5 Vitamin D insufficiency
(Randomized controlled) ( CI 95% 346 fewer among young infants
6 Important — 189 fewer )
Vitamin D
deficiency:
287 75
Relative risk 0.26 per 1000 per 1000
25-OH vitamin D Vitamin D
(CI 95% 0.11 — 0.61) Moderate
< 30 nmol/L supplementation may
Based on data from 281 Difference: 212 fewer per Due to serious
3-6 months 6 7 decrease the incidence of
participants in 4 studies. 1000 indirectness Vitamin D deficiency
(Randomized controlled) ( CI 95% 255 fewer
6 Important — 112 fewer )
Adverse effects
(hypercalcaemia)
70 102
Relative risk 1.45 per 1000 per 1000 Very low We are uncertain whether
8
(CI 95% 0.54 — 3.86) Due to serious risk supplementing Vitamin D
3-6 months Based on data from 170 Difference: 32 more per 1000 of bias, Due to increases the incidence of
9 10
participants in 2 studies. ( CI 95% 32 fewer imprecision hypercalcemia.
6 Important — 200 more )
Adverse effects Relative risk 3 0 0 Low

(others) (CI 95% 0.14 — 64.26)
per 1000 per 1000 Due to serious risk Vitamin D
3-6 months Based on data from 121
of bias, Due to supplementation does
participants in 4 studies.
11
Difference: 0 fewer per 1000 serious not cause any harms
(Randomized ( CI 95% 0 fewer 12
6 Important imprecision
controlled) — 0 fewer )
Measured by:Dual-energy- Difference: MD 0.01 lower

Xray absorptiometry ( CI 95% 0.02
Bone Mineral (DEXA) of lumbar spine
We are uncertain whether
lower — 0 lower )
Density Vitamin D
High better Moderate
4 months supplementation
Based on data from 72 Due to serious
improves bone mineral
participants in 1 studies. imprecision
14
13 density at the end of the
6 Important (Randomized
intervention
controlled)
Follow up: 4 months.
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Outcome Study results and Placebo OR No Intervention the Evidence
Summary
Timeframe measurements supplementatio Vitamin D (Quality of
n evidence)
Bone mineral Difference: MD 3.93 higher Very low

content at the ( CI 95% 2.42 Due to serious risk
vitamin D
end of Based on data from 56 lower — 10.27 of bias, Due to
supplementation
participants in 2 studies. higher ) serious
intervention 15 improves bone mineral
(Randomized inconsistency, Due
content at the end of
controlled) to serious
6 Important 16 intervention
Follow up: 3-6 months. imprecision
Serum 25-OH Difference: MD 34.54 higher

vitamin D level at ( CI 95% 29.86
latest time higher — 39.22
Supplementation of
reported to six Based on data from 493 higher ) Moderate
Vitamin D may improve
participants in 8 studies. Due to serious
months of age 17 18 serum 25-OH Vitamin D
6 months (Randomized indirectness levels.
controlled)
Follow up: 3-6 months.
6 Important
Difference: MD 247.63 Very low

Size at latest higher Due to serious We are uncertain whether
time measured: Based on data from 215 ( CI 95% 29.59 inconsistency, Due Vitamin D
weight participants in 3 studies. higher — 465.67 to serious supplementation
19 higher ) imprecision, Due
(Randomized improves weight at the
controlled) to serious risk of latest time measured
20
Follow up: 3-6 months. bias
Size at latest Difference: MD 0.49 higher

Low
time measured: ( CI 95% 0.13 Vitamin D
Due to serious
Based on data from 228 lower — 1.12 supplementation may
length inconsistency, Due
participants in 4 studies. higher ) improve length at latest
21 to serious risk of
(Randomized 22 time measured slightly
bias
controlled)
Size at latest Difference: MD 0.37 higher

Vitamin D
time measured: ( CI 95% 0.03 Low
supplementation may
head Based on data from 177 lower — 0.78 Due to serious risk
have little or no
participants in 2 studies. higher ) of bias, Due to
circumference 23 difference on head
(Randomized serious
24 circumference at the
controlled) inconsistency latest time measured
Follow up: 3.5-4 months.
1. Systematic review [106] . Baseline/comparator: Control arm of reference used for intervention.
2. Inconsistency: no serious. Indirectness: serious. Differences between the population of interest and
those studied: 1) One of the studies (Lin 2022) excluded 14 neonates with vit D deficiency (measured at birth)
2) exclusion of mothers at risk of vitamin D deficiency- pre eclampsia, Gestational diabetes, oligohydramnios
or polyhydramnios and mothers with vit D deficiency Or mothers who had received vitamin D before delivery
Differences between the intervention/comparator of interest and those studied: contamination of groups
due to administration of vit D fortified formula . Imprecision: serious. No event rate . Publication bias: no
serious.
3. Vitamin D levels measured after 3- 6 months of age
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4. Systematic review [106] with included studies: Lin 2022, Moodley 2015, Chandy 2016, Rueter 2019, Madar
2009, Ruangkit 2022. Baseline/comparator: Control arm of reference used for intervention.
5. Inconsistency: no serious. The magnitude of statistical heterogeneity was high, with I2:73 %.
Indirectness: serious. Some amount of formula usage in 3 studies; but equally distributed in both the
groups. Outcome of vit D insufficiency may not be related to bone health.. Imprecision: no serious.
Publication bias: no serious.
6. Systematic review [106] with included studies: Moodley 2015, Lin 2022, Ruangkit 2022, Chandy 2016.
Baseline/comparator: Control arm of reference used for intervention.
7. Inconsistency: no serious. Indirectness: serious. Vitamin D deficiency may not be reflective of status of
bone health and incidence of nutritional rickets.. Imprecision: no serious. Publication bias: no serious.
8. hypercalcemia as defined by the study
9. Systematic review [106] with included studies: Lin 2022, Chandy 2016. Baseline/comparator: Control arm
of reference used for intervention.
10. Indirectness: no serious. Imprecision: serious. Wide confidence intervals, Low number of patients.
11. Systematic review [106] with included studies: Ponnapakkam 2010, Madar 2009, Moodley 2015, Lin
2022. Baseline/comparator: Control arm of reference used for intervention.
12. Risk of Bias: serious. Incomplete data and/or large loss to follow up. Inconsistency: no serious.
Indirectness: no serious. Imprecision: serious. Wide confidence intervals. Publication bias: no serious.
13. Primary study[91]. Baseline/comparator: Control arm of reference used for intervention.
14. Inconsistency: no serious. Single study. Indirectness: no serious. Imprecision: serious. Only data
from one study. Publication bias: no serious.
15. Systematic review [106] with included studies: Greer 1981, Greer 1989. Baseline/comparator: Control
arm of reference used for intervention.
16. Risk of Bias: serious. Inconsistency: serious. Point estimates vary widely, The confidence interval of
some of the studies do not overlap with those of most included studies/ the point estimate of some of the
included studies., The direction of the effect is not consistent between the included studies. Indirectness: no
serious. Imprecision: serious. Wide confidence intervals. Publication bias: no serious.
17. Systematic review [106] with included studies: Madar 2009, Lin 2022, Greer 1989, Chandy 2016, Rueter
2019, Alonso 2011, Ruangkit 2022, Moodley 2015. Baseline/comparator: Systematic review.
18. Inconsistency: no serious. The magnitude of statistical heterogeneity was high, with I^2: 89%..
Indirectness: serious. Differences between the outcomes of interest (rickets or bone mineral density) and
those reported (Vitamin D levels). Imprecision: no serious. Publication bias: no serious.
19. Systematic review [106] with included studies: Lin 2022, Greer 1989, Chandy 2016. Baseline/
comparator: Control arm of reference used for intervention.
20. Risk of Bias: serious. Incomplete data and/or large loss to follow up. Inconsistency: serious. Point
estimates vary widely. Indirectness: no serious. Imprecision: serious. Wide confidence intervals.
21. Systematic review [106] with included studies: Greer 1989, Chandy 2016, Lin 2022, Greer 1981. Baseline/
estimates vary widely. Indirectness: no serious. Imprecision: no serious. Publication bias: no serious.
23. Systematic review [106] with included studies: Lin 2022, Chandy 2016. Baseline/comparator: Control
arm of reference used for intervention.
estimates vary widely. Indirectness: no serious. Imprecision: no serious. Publication bias: no serious.
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8. Among healthy neonates weighing >1800 g, is body massage with or without oil
superior to no body massage?
Infant massage is a traditional activity practiced by care providers in many parts of the world, especially in Asia and
Africa. Massage is done with or without the use of a variety of oils; e.g. coconut oil, mustard oil, mineral oil, olive oil
or other vegetable oils. A Cochrane review in 2013 by Bennet et al (34 studies)[107] assessed the benefits of
massage on health outcomes in the first 6 months of life and found no significant benefits. Most of the studies
included in the review had a high risk of bias and the authors concluded that evidence did not support the routine
use of massage among term, healthy neonates. A recent systematic review by Mayank et al in 2022 (31 studies;
3860 participants) [108]found uncertain benefits of infant massage on growth, behavior and neurodevelopmental
outcomes, with most studies at a high risk of bias.
Weak recommendation , Very low certainty evidence
Body massage with or without oil is not likely to have substantial beneficial or harmful effects on the health of healthy neonates.
The family may choose to massage the infant based on their cultural practice.
There is very low quality evidence to suggest that infant massage does not lead to any significant improvement in weight and
length at 6 weeks among healthy, term neonates.
Certainty of the Evidence Very low
The overall certainty of evidence for the beneficial health outcomes of infant massage was low (Length, Neurobehavior-
psychomotor development index, Crying and Neonatal Jaundice) to very low (Weight, Head Circumference, Neurobehavior-
MDI and Sleep)
Infant massage with or without the use of oil is a traditional practice in many societies across the world with no major reported
harmful effects. Given its established traditional role, there is no variability or uncertainty in the practice of infant massage
among different cultures.
Being a common practice in many parts of the world, infant massage does not take up too many resources or cost, however,
the cost-effectiveness of infant massage has not been reported in most of the studies included in this review.
There are no significant concerns regarding equity as this is a universally practiced, traditional custom in many parts of the
world, across all socio-economic strata and levels of society. This outcome has however, not been reported in most of the
included studies.
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Most cultures and societies have been practicing infant massageas a routine and will have no issues with its acceptability;
however, this outcome has not been reported in most studies.
Infant massage is a feasible, traditional practice and there are no concerns regarding this issue. However, as noted above, for
most of these outcomes (acceptability, resources, equity & cost-effectiveness), most of the available studies have not reported
on these outcomes.
Rationale
The GDG does not recommend for or against infant massage. This is a weak/ conditional recommendation, based on very low
certainty of available evidence. Most of the included studies have a high risk of bias and have not shown a statistically significant
benefit on growth, neurodevelopment or sleep & crying. Despite, infant massage being a common traditional practice in many
societies, with no reported harmful effects, the GDG feels that the available evidence is not in favor of or against infant massage.
Future studies with robust clinical designs may clarify some of these issues.
Population: Term, healthy neonates

Intervention: Whole-body massage with/without oil
Comparator: No massage
Certainty of
Intervention
Whole-body Summary
Timeframe measurements No massage (Quality of
massage
evidence)
Neonatal/ Infant
Relative risk 0 0 0
(CI 95% 0 — 0) No studies were
per 1000 per 1000 No studies were found
mortality Based on data from 0 found that looked
1 that looked at neonatal/
participants in 0 studies. at neonatal/ infant
Difference: 0 fewer per 1000 infant mortality
9 Critical (Randomized controlled) ( CI 95% 0 fewer mortality
Follow up: 0. — 0 fewer )
Systemic
Relative risk 0 0 0
(CI 95% 0 — 0) No studies were
infections Based on data from 0 found that looked
that looked at systemic
participants in 0 studies. at systemic
Difference: 0 fewer per 1000 infections
9 Critical (Randomized controlled) ( CI 95% 0 fewer infections
Follow up: 0. — 0 fewer )
Measured by: weighing 5,239.52 5,576.82 Very low

Weight scale Due to very
g (Mean) g (Mean)
High better serious risk of bias, Whole-body massage
Based on data from 2,182 Due to serious may improve weight
6 Important Difference: MD 340.3 higher
participants in 17 studies. inconsistency, Due
2 ( CI 95% 239.81
(Randomized to serious
lower — 440.79
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Certainty of
Intervention
Whole-body Summary
massage
evidence)
controlled) higher ) 3
imprecision
Follow up: 2.
Infantometer
Measured by: 55.78 57.39
cm (Mean) cm (Mean) Low
Length High better
Due to very
Based on data from 1,294 Whole-body massage
serious risk of bias,
4 Difference: MD 1.58 higher may improve length
6 Important Due to serious
(Randomized controlled) ( CI 95% 1.42 5
lower — 1.74 imprecision
Follow up: 1.
higher )
Measured by: Measuring 37.97 38.88 Very low

Head tape Due to very
cm (Mean) cm (Mean)
circumference High better serious risk of bias, Whole-body massage
Based on data from 1,000 Due to serious may improve head
Difference: MD 0.85 higher
participants in 6 studies. inconsistency, Due circumference
6 Important ( CI 95% 0.57
(Randomized controlled) to serious
lower — 1.14 6
Follow up: 1. higher ) imprecision
Neurodevelopm Measured by: Mental 108.77 109.43 Very low

ent/ Development Indices Due to very
Scores (Mean) Scores (Mean) whole-body massage
Neurobehavior - High better serious risk of bias,
improves or worsen
Based on data from 388 Due to serious
MDI Difference: MD 0.29 higher neurodevelopment/
participants in 3 studies. inconsistency, Due
( CI 95% 0.18 neurobehavior - Mental
(Randomized controlled) to serious
6 Important lower — 0.77 7 Development Indices
Neurodevelopm Measured by:Psychomotor 108.18 111.73 We are uncertain whether

ent/ Development Indices
Score (Mean) Score (Mean) Low whole-body massage
Neurobehavior - High better Due to very improves or worsen
Based on data from 388 serious risk of bias, neurodevelopment/
PDI Difference: MD 0.39 higher
participants in 3 studies. Due to serious neurobehavior -
( CI 95% 0.18 8
(Randomized controlled) imprecision Psychomotor
6 Important lower — 0.6
Follow up: 1. Development Indices
higher )
Duration over
Measured by: 18.97 19.66 Very low
24-hr period in hours Due to very We are uncertain whether
hours (Mean) hours (Mean)
Sleep High better serious risk of bias, whole-body massage
Based on data from 534 Due to serious improves or worsens
Difference: MD 0.62 higher
6 Important participants in 3 studies. inconsistency, Due sleep duration among
( CI 95% 0.12
(Randomized controlled) to serious infants
lower — 1.12 9
Crying
Hours per day
Measured by: 1.87 1.54 Low
Lower better whole-body massage
hours/day (Mean) hours/day (Mean) Due to very
Based on data from 271 improves or worsen
serious risk of bias
6 Important participants in 3 studies. crying/ fussing time
Difference: MD 0.37 lower 10
(Randomized controlled) among infants
( CI 95% 0.21
36 of 103
Certainty of
Intervention
Whole-body Summary
massage
evidence)
lower — 0.53
Follow up: 1.
lower )
Measured by: Lab 185.35 152.85

Neonatal mmol/L (Mean) mmol/L (Mean) Low
Bilirubinometer We are uncertain whether
jaundice Due to very
Lower better whole-body massage
serious risk of bias,
Based on data from 345 Difference: MD 31.75 lower improves or worsen
Due to serious
6 Important participants in 4 studies. ( CI 95% 23.46 11 neonatal jaundice
lower — 40.05 imprecision
(Randomized controlled)
lower )
1. Systematic review [109] . Baseline/comparator: Control arm of reference used for intervention.
2. Systematic review [109] . Baseline/comparator: Systematic review [109] .
3. Risk of Bias: very serious. Inadequate sequence generation/ generation of comparable groups, resulting
in potential for selection bias, Incomplete data and/or large loss to follow up, Inadequate concealment of
allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding
of participants and personnel, resulting in potential for performance bias, Selective outcome reporting.
Inconsistency: serious. The magnitude of statistical heterogeneity was high, with I^2: 86%.. Indirectness:
no serious. Imprecision: serious. Wide confidence intervals. Publication bias: no serious.
4. Systematic review. Baseline/comparator: Systematic review [109] .
in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in
potential for performance bias, Incomplete data and/or large loss to follow up, Selective outcome reporting,
Inadequate concealment of allocation during randomization process, resulting in potential for selection bias.
Inconsistency: no serious. Indirectness: no serious. Imprecision: serious. Wide confidence intervals.
in potential for selection bias, Inadequate concealment of allocation during randomization process, resulting
potential for performance bias, Incomplete data and/or large loss to follow up, Selective outcome reporting.
no serious. Imprecision: serious. Wide confidence intervals, Low number of patients. Publication bias: no
serious.
Inconsistency: no serious. Indirectness: no serious. Imprecision: serious. Wide confidence intervals.
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10. Risk of Bias: very serious. Inadequate sequence generation/ generation of comparable groups,
resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in
Inconsistency: no serious. Indirectness: no serious. Imprecision: no serious. Publication bias: no
serious.
Inconsistency: no serious. Indirectness: no serious. Imprecision: serious. Low number of patients.
38 of 103
9. Among healthy neonates, is chlorhexidine or any other antiseptic application on the

umbilical cord stump superior to dry cord care?
Neonatal sepsis is the major contributor to mortality in the first 28 days of life in LMIC. Globally, it accounts for around 30% of the total
3.1 million neonatal deaths. Umbilicus after birth is considered as the major entry point for invasive pathogens leading to neonatal
sepsis. Home birth, unhygienic cord cutting, and traditional practices could expose the cord to more hostile environment leading to
sepsis or even mortality.[110]
An unhygienic umbilical cord can lead to omphalitis, systemic sepsis, and death. Keeping the umbilical cord stump clean and dry can
reduce the risk of local and systemic infections. Application of topical antiseptic is one of the simple and seemingly cost-effective
intervention which can avert sepsis and reduce neonatal mortality to large extent. [111][112][113] Chlorhexidine (CHX) which is the
commonly used and most studies showed that applying antiseptic could also prevent the colonization of the cord with pathogenic
bacteria. This practice question evaluated if the application of CHX to umbilical cord stump is superior to dry cord care.[114]
The umbilical cord should be kept clean and dry.
Conditional recommendation: Chlorhexidine may be applied to the umbilical cord in term or late preterm infants in settings with a
high neonatal mortality rate (>30 per 1000 live births) or a high incidence of omphalitis.
Practical info
Most studies evaluating the efficacy of chlorhexidine have used 4% solution applied once a day to the umbilical
cord till the stump falls.
Research evidence
A total of 8 studies conducted from 2006-2016 (7 RCTs & 1 Non-randomized study of intervention (NRSI) /Quasi-
experimental)) were included in the assessment [115][116][117][118][119][120][121][122] four of which were cluster
RCTs and three were RCTs. All studies except one, were conducted in LMICs, including Nepal, Pakistan, Bangladesh, Tanzania,
Zambia, and India. The only observational study was conducted in South Sudan. All studies except one used 4% CHX solution,
the lone study used 1% free CHX powder. The baseline neonatal mortality in studies ranged from 31 to 40 per 1000 live births.
Use of unhygienic cord practices ranged from <1% to 90% across all studies.
a. Neonatal Mortality: Pooled estimate from 6 RCTs (n=124 414) with moderate certainty of evidence suggests application of
CHX to the umbilical cord as compared to dry care/no care showed slight benefit in reduction on overall neonatal mortality in
the first 28 days of life. Subgroup analysis based on birth weight (<2.5 kg- 3 studies, n=11290) and >2.5 kg - 3 studies, n=780
99) did not show any difference in mortality between CHX and dry/usual care groups. Subgroup analysis based on gestational
age (preterm <37 weeks - 2 studies n=13190, term > 37 weeks - 2 studies, n=50600) also did not show any difference in
mortality in the two groups. In two studies that reported separate data on the outcomes in facility births (n=605 69) and home
births (n=50418), no difference was observed between the two groups. The data could not be analyzed based on differences in
baseline mortality rate, as all 5 major RCTs reported baseline NMR above 30 per 1000 live births. The outcomes did not
differentiate between the two groups even with high facility birth settings. The single observational study reported neonatal
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mortality of 1.3% vs 13.3% between CXG vs dry care.
b. Omphalitis: Moderate or severe redness with or without pus was considered as the definition of omphalitis for this analysis.
Data from 7 studies (n=124 753) showed use of CHX did reduce the incidence of omphalitis significantly by 40% (low certainty
of evidence). The evidence was downgraded by two levels due to a high risk of bias and indirectness (7 of 6 recorded
omphalitis as a secondary outcome). The only NRSI reported a cord infection rate of 17.3% vs. 38.8% between CHX vs dry care,
respectively. 4 were Cluster RCTs, and 3 were individual RCTs. All studies except one, were conducted in LMICs, including
Nepal, Pakistan, Bangladesh, Tanzania, Zambia, and India. The only observational study was conducted in South Sudan. All
studies except one used 4% Chlorhexidine (CHX) solution, the lone study used 1% free CHX powder. The baseline neonatal
mortality in studies ranged from 31-40 per 1000 live births. Use of unhygienic cord practices ranged from <1-90% across all
studies.
c. Neonatal Sepsis: Only one study conducted in a facility setting reported neonatal sepsis data (probable or culture-proven or
meningitis). Culture-positive sepsis was significantly lower in CHX group (2.8% vs 21.4%; ; RR 0.13; 95%CI:0.03-0.56) . When the
data for probable or culture-proven or meningitis is combined then the pooled estimate shows significant reduction in
neonatal sepsis (RR 0.44 ; 95%CI: 0.20-0.95).The evidence was low certainty due to serious risk of bias and serious indirectness.
No significant difference was observed in the two groups (low certainty of evidence).
d. Undesirable outcomes: One study reported adverse events like skin irritation or ocular exposure. No difference was observed
between the two groups (very low certainty of evidence due to serious risk of bias, indirectness, and imprecision).
Summary
Moderate certainty evidence suggests no reduction in neonatal mortality with CHX application on the cord stump. Low
certainty evidence from high NMR setting indicates that the incidence of omphalitis is reduced with CHX application.
Research evidence
The certainty of evidence for the critical outcome of neonatal mortality was moderate. The evidence was downgraded by one
level due to the lack of blinding of intervention or outcome assessors. The certainty of the evidence was low for omphalitis due
to the high risk of bias and serious indirectness. For important outcomes of neonatal sepsis and adverse reactions, the certainty
of evidence was low and very low respectively.
Summary
Moderate certainty evidence suggests no reduction in neonatal mortality with CHX application on the cord stump. Low
certainty evidence from high NMR setting indicates that the incidence of omphalitis is reduced with CHX application.
Research evidence
There is a wide range of practices in the Indian context on cord care depending on the geographic location, educational status
of the mother, religion, and family practices. Nonetheless, findings from one review indicate that women tend to prioritize the
needs of their baby and are highly likely to value any strategy that fosters infant development and enhances breastfeeding
and/or their baby’s general well-being (high confidence in the evidence).
Summary
Substantial variability is expected in the values and practices in Indian context in cord care after birth.
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Research evidence
No evidence on cost-effectiveness steady for CHX, despite WHO classified it as one of the Essential medicine
for Children.
The WHO Model List of Essential Medicines for Children includes CHX “solution or gel: 7.1% (digluconate) delivering 4%
chlorhexidine (for umbilical cord care)”[123]
Summary
No evidence on cost-effectiveness steady for CHX, despite WHO classified it as one of the Essential medicine
for Children.
Research evidence
There was no direct or indirect evidence to comment on the impact on health equity. Theoretically CHX
could help address the health inequity considering the burden of sepsis related mortality and morbidity in
Indian context. Nonetheless the large number of babies to be covered and sparse evidence on the benefits
of CHX application over dry cord care could possibly incline the advocacy team towards dry care.
Summary
No direct or indirect evidence on health equity .
Research evidence
There is no evidence on the acceptability of CHX in Indian context. A survey study conducted in a tribal
community in south Indian revealed more than 90% of woman prefer to apply substance(coconut oil, sweet
flag , turmeric) to umbilical cord.[124] Indirect evidence from the review suggests that most women
appreciate advice and information from health workers about treatments and techniques that optimize
infant well-being [125] The acceptance varies from rural to urban considering diverse population in Indian
scenario.
Summary
No direct evidence on acceptance, indirect evidence suggest mothers may accept CHX application if its
beneficial for their infant especially when the advice comes from healthcare workers.
Research evidence
Indirect evidence from a review indicates that some women in LMICs may be less likely to use chlorhexidine
if they believe that treatment will incur additional or unnecessary costs (moderate confidence in the
evidence). A qualitative evidence synthesis of health workers’ experiences of postnatal care found no direct
evidence relating to views on the feasibility of using chlorhexidine. However, indirect evidence suggests that
lack of personnel, resources, and training may limit the provision of information and counselling on cord
care during the postnatal period (moderate confidence in the evidence).[125][126]
Summary
Although the application of CHX to umbilical cord appears to be feasible but considering factors like cost,
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additional resources and training the cumulative effect on feasibility varies.
Population: Newborns
Intervention: Chlorhexidine (CHX) application
Comparator: Dry care or No care
Certainty of
Intervention
Chlorhexidine Summary
Timeframe measurements Dry care (Quality of
(CHX)
evidence)
Neonatal Relative risk 0.88 13 11

Mortality - (CI 95% 0.81 — 0.96) Chlorhexidine (chx)
per 1000 per 1000 Moderate
Based on data from probably improves
Overall Due to serious risk
124,414 participants in 6 neonatal mortality -
1
Difference: 2 fewer per 1000 of bias
2
studies. (Randomized overall slightly
9 Critical ( CI 95% 2 fewer
Neonatal Relative risk 1.03 13 13 Chlorhexidine (chx)

Mortality - Term (CI 95% 0.88 — 1.2)
per 1000 per 1000 Moderate probably has little or no
Based on data from
(>37wks) Due to serious risk difference on neonatal
50,600 participants in 2
3
4 mortality in term infants
studies. (Randomized ( CI 95% 2 fewer
9 Critical (>37wks)
controlled) — 3 more )

Mortality - (CI 95% 0.84 — 1.16)
Based on data from
Facility based Due to serious risk difference on neonatal
5
6 mortality in facility based
9 Critical situations
Neonatal
Mortality -
Relative risk 0.87 13 11 Chlorhexidine (chx) may
(CI 95% 0.74 — 1.03) per 1000 per 1000
Preterm Moderate have little or no
Based on data from
Due to serious risk difference on neonatal
(<37wks) 13,190 participants in 2 Difference: 2 fewer per 1000 8
7 of bias mortality in preterm
studies. (Randomized ( CI 95% 3 fewer infants (<37wks)
9 Critical controlled) — 0 fewer )

Mortality - Birth (CI 95% 0.87 — 1.32)
Based on data from
weight (>2.5kg) Due to serious risk difference on neonatal
9
Difference: 1 more per 1000 of bias
10 mortality in infants with
9 Critical birth weight (>2.5kg)
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Certainty of
Intervention
Chlorhexidine Summary
Timeframe measurements Dry care (Quality of
(CHX)
evidence)

Mortality - Low. (CI 95% 0.73 — 1.06)
birth weight ( Based on data from
11
12 mortality in low birth
9 Critical weight infants (
Neonatal
Mortality -
Relative risk 1.11 13 14 Chlorhexidine (chx)
(CI 95% 0.89 — 1.38) per 1000 per 1000
Community Moderate probably has little or no
Based on data from
based 50,418 participants in 2 Difference: 1 more per 1000 14
13 of bias mortality in community
studies. (Randomized ( CI 95% 1 fewer settings.
9 Critical controlled) — 5 more )
Relative risk 0.6 22 13 Low Chlorhexidine (chx)

Omphalitis (CI 95% 0.55 — 0.65)
per 1000 per 1000 Due to serious risk application may
Based on data from
of bias, Due to omphalitis by 35-45% ,
9 Critical 15
Difference: 9 fewer per 1000 serious with low certainty of
studies. (Randomized ( CI 95% 10 fewer 16
indirectness evidence.
Odds ratio 0.44 343 186

per 1000 per 1000 Low
Neonatal Sepsis (CI 95% 0.2 — 0.95) Chlorhexidine (chx) may
Due to serious risk
Based on data from 140 have little or no
of bias, Due to
participants in 1 studies. Difference: 156 fewer per difference on neonatal
9 Critical serious
17
(Randomized 1000 18 sepsis
( CI 95% 248 fewer indirectness
controlled)
— 11 fewer )
Adverse
Relative risk 19.86 0 0 Very low
Due to serious risk
Risk of accidental
(CI 95% 1.16 — 341.16) per 1000 per 1000 exposure or any adverse
reactions of bias, Due to
Based on data from reactions are not different
serious
37,856 participants in 1 Difference: 0 fewer per 1000 during chx applications
19 indirectness, Due
6 Important studies. (Randomized ( CI 95% 0 fewer with very low certainty of
to serious
controlled) — 0 fewer ) 20 evidence.
imprecision
1. Systematic review [127] with included studies: Geeta G 2013, Arifeen 2012, Katherine 2016, Mullany C L
2006, Soofi S 2012, Sazawal S 2016. Baseline/comparator: Control arm of reference used for intervention.
2. Risk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for
performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias.
serious.
3. Systematic review [127] with included studies: Katherine 2016, Arifeen 2012. Baseline/comparator:
Control arm of reference used for intervention.
4. Risk of Bias: serious. Inadequate/lack of blinding of outcome assessors, resulting in potential for
detection bias, Inadequate/lack of blinding of participants and personnel, resulting in potential for
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performance bias. Inconsistency: no serious. Indirectness: no serious. Imprecision: no serious.

5. Systematic review [127] with included studies: Katherine 2016, Sazawal S 2016. Baseline/comparator:
performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias.
serious.
7. Systematic review [127] with included studies: Arifeen 2012, Katherine 2016. Baseline/comparator:
9. Systematic review [127] with included studies: Arifeen 2012, Sazawal S 2016, Katherine 2016. Baseline/
11. Systematic review [127] with included studies: Katherine 2016, Arifeen 2012, Sazawal S 2016. Baseline/
12. Risk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential
for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection
bias. Inconsistency: no serious. Indirectness: no serious. Imprecision: no serious. Publication bias: no
serious.
13. Systematic review [127] with included studies: Katherine 2016, Sazawal S 2016. Baseline/comparator:
15. Systematic review [127] with included studies: Katherine 2016, Soofi S 2012, Mullany C L 2006, Kapellen
M T 2009, Geeta G 2013, Sazawal S 2016, Arifeen 2012. Baseline/comparator: Control arm of reference used
for intervention.
16. Risk of Bias: serious. Inconsistency: no serious. Indirectness: serious. Differences between the
outcomes of interest and those reported (e.g short-term/surrogate,not patient-important), due to [reason].
Imprecision: no serious. Publication bias: no serious.
17. Systematic review [127] with included studies: Geeta G 2013. Baseline/comparator: Control arm of
reference used for intervention.
bias. Inconsistency: no serious. Indirectness: serious. due to [reason]. Imprecision: no serious.
19. Systematic review [127] with included studies: Katherine 2016. Baseline/comparator: Control arm of
bias. Inconsistency: no serious. Indirectness: serious. due to [reason], due to [reason]. Imprecision:
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serious. Only data from one study, Wide confidence intervals. Publication bias: no serious.
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10. Among healthy neonates, is the instillation of antibiotic eye drops at birth superior to
no antibiotic instillation?
Neonatal conjunctivitis or ophthalmia neonatorum Is a common illness that affects both term and preterm neonates. The etiology may
be infectious (bacterial or viral) or non-infectious (toxic, allergic, or non-specific). Clinical features of conjunctivitis include watery or
mucopurulent eye discharge, swelling of the eyelids, and conjunctival congestion. Though usually self-limited, conjunctivitis due to
Neisseria gonorrhea and Chlamydia trachomatis may cause serious ocular complications resulting in blindness. Hence, the WHO and
some national guidelines recommend single-time instillation of antibiotic eye drops soon after birth to prevent conjunctivitis. However,
the prevalence of the problem especially that of severe forms of conjunctivitis such as gonococcal and chlamydial conjunctivitis is
variable and largely unknown[128][129]. Though available data suggests that the prevalence of gonococcal and chlamydial
conjunctivitis has significantly decreased in high-income countries[130] , it is possible that the prevalence is still high in
LMIC [129][131] . The other factors for consideration include the effectiveness of routine antibiotic prophylaxis in preventing neonatal
conjunctivitis and its associated blindness and the appropriate choice of antibiotic for routine prophylaxis. Since the number needed to
prevent a single additional case of blindness due to ophthalmia neonatorum may be high, the cost-effectiveness of universal antibiotic
prophylaxis also needs to be considered [132].
Prophylactic antibiotic eye drops may not be used in neonates at birth for prevention of ophthalmia neonatorum.
Research evidence
The Cochrane review [133] included 30 trials with a total of 79,198
neonates [134][135][136][137][138][139][140][141][142][143][144][145][146][147][148][149][150][151][152][153][154][15
Eighteen studies were conducted in high-income settings (the USA, Europe, Israel,Canada), and 12 were
conducted in low- and middle-income settings (Africa, Iran, China, Indonesia, Mexico). There were 14
different prophylactic regimens and 12 different medications in the 30 included studies.
There is no evidence from the included RCTs on the impact of routine antibiotic prophylaxis for prevention
of conjunctivitis in neonates on any of the critical outcomes such as neonatal mortality, infant mortality, need
for hospital admission, blindness at one year follow-upand any adverse visual outcome atone year follow up.
We are uncertain about the effect of routine antibiotic prophylaxis on Gonococcal conjunctivitis, Chlamydial
conjunctivitis and bacterial conjunctivitis (No reduction, Very Low CoE).
However, routine antibiotic prophylaxis may reduce conjunctivitis of any etiology [23% reduction (95% CI 15
to 31%), Low CoE].
For the potential harms of routine antibiotic prophylaxis, we are uncertain about the effect of routine
antibiotic prophylaxis on nasolacrimal duct obstruction and keratitis (No effect, Very Low CoE).
1. Limitations of available evidence: > 50% trials were conducted 20 years ago
2. Most of the agents used in the included RCTs such as silver nitrate, povidone iodine, tetracycline are not
in use now - Not relevant to the current scenario
3. Most damaging is the Gonococcal followed by Chlamydial conjunctivitis. Other bacterial conjunctivitis
and non-bacterial conjunctivitis do not often cause serious visual adverse effects
4. The available Indian data shows variable incidence.
5. The causative organism of conjunctivitis varies. In the study by Suhas et al [128] from Chennai, the
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incidence of Chlamydia as the cause of conjunctivitis was 0%. Whereas, in the study by Kakar et al from New
Delhi [129], the positive rate of Chlamydia (based on antigen test) was 31%
6. Prevalence of STIs among women of reproductive age group is also variable. In the study by Munro et al
from Mysore district, Karnataka state, southern India [167], the incidence of Gonorrhea was 0% and
Chlamydia was 2%. Whereas in the study by Chaudhary et al from UP [168], the incidence of Gonorrhea was
2% and Chlamydia was 4%.
7. On the contrary, there is no universal screening for genital tract infections in pregnant women in India.
Hence, missed diagnosis of STIs is likely to be high.
Summary
We are uncertain regarding the incidence of the most damaging Gonococcal and Chlamydial conjunctivitis in India. Also, we
are uncertain about the impact of routine antibiotic prophylaxis on these and all other critical outcomes.
Research evidence
Very limited data is available.
• No evidence for any of the critical outcomes

• Very low CoE for Gonococcal conjunctivitis, Chlamydial conjunctivitis and bacterial conjunctivitis
• Very low CoE for potential adverse effects.
• Low CoE only for "conjunctivitis of any aetiology"
Summary
The overall certainty of evidence is very low for both the potential benefIts and harms of the interventIon.
Research evidence
No evidence
Though visual outcomes are very important, since the prevalence of STI and Gonococcal/Chlamydial conjunctivitis are not
known, it is difficult to ascertain patient values.
No adequate data on the choice of antibiotic eye drops as well.Undesirable effects would vary with the choice of antibiotic eye
drops.
Summary
We are unable to comment on patient values and preferences, since we are uncertain about the baseline risk of the condition
and the effect of the intervention.
Research evidence
The intervention would incur moderate health-care costs. However, no special resource is required. It is a feasible intervention
that can be implemented if proven effective.
No special resource is required.
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However,
1. Though antibiotic eye drops are relatively cheap, universal prophylaxis would significantly increase health-care costs.
2. It will be an added responsibility of the labour room nurse or postnatal ward nurse - might be a burden in high volume
centers.
Though universal antibiotic prophylaxis would incur moderate health-care cost, it would be cost-effective if there is significant
impact on prevention of blindness/ adverse visual outcomes. However, since there is no data on these, we are unable to
comment on the cost-effectiveness of the intervention.
Summary
The intervention would incur moderate health-care costs. However, no special resource is required. It is a feasible intervention
that can be implemented if proven effective.
Research evidence
No evidence
None
Summary
Since it is an intervention that can be implemented easily even in resource-limited settings, there is no issue on ‘equity’.
Research evidence
No evidence
Once the intervention is proven to be effective, it is likely to be acceptable to all key stakeholders.
Summary
The intervention is likely to be acceptable to all key stakeholders.
Research evidence
No evidence
The intervention is feasible.
Except for the moderate health-care costs and manpower aspects, as discussed above.
Summary
It is a feasible intervention.
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Rationale
Overall justification
There is limited data on the effectiveness of the intervention.
Prevalence of the problem in India is variable and available data on prevalence is limited.
Detailed justification
Problem
The incidence of the problem varies across the country.
Desirable Effects
No data on critical outcomes. Low to very low CoE data for important outcomes. There is no data on the effect
of routine antibiotic prophylaxis on critical outcomes such as neonatal or infant mortality, need for hospital
admission, and blindness or adverse visual outcome at 1 year. we are uncertain about the effect of routine
antibiotic prophylaxis on Gonococcal, Chlamydial and bacterial conjunctivitis, and on possible adverse effects
(Very low certainty of evidence). The intervention may reduce 'conjunctivitis of any aetiology' (Low certainty of
evidence)
Undesirable Effects
Very low certainty of evidence on possible adverse effects due to the intervention
Balance of effects
Difficult to ascertain due to limited data
Cost effectiveness
Difficult to ascertain due to limited data on the prevalence of the problem and effectiveness of the intervention
We are unable to comment on patient values and preferences, since we are uncertain about the baseline risk of the condition and
the effect of the intervention.
Population: Newborn infants

Intervention: Routine antibiotic prophylaxis
Comparator: No prophylaxis
Intervention Certainty of
Outcome Study results and Comparator Routine the Evidence
Summary
Timeframe measurements No prophylaxis antibiotic (Quality of
prophylaxis evidence)
Neonatal
mortality
1 Relative risk CI 95% No studies were found
that looked at neonatal
mortality
7 Critical
No studies were found

2 Relative risk
Infant mortality CI 95% that looked at infant
mortality
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Summary
8 Critical
Blindness (V/A
<20/200) at one CI 95%
Relative risk No studies were found
3
year that looked at blindness
(v/a <20/200) at one year
9 Critical
Any adverse
visual outcome CI 95% No studies were found
Relative risk
at one year
4 that looked at any
adverse visual outcome at
one year
9 Critical
Gonococcal Relative risk 0.79 50 40 Very low

per 1000 per 1000 Due to serious risk We are uncertain whether
conjunctivitis (CI 95% 0.24 — 2.65)
of bias, Due to routine antibiotic
1 month Based on data from 8,229
very serious prophylaxis increases or
participants in 3 studies. Difference: 10 fewer per
imprecision, Due decreases gonococcal
(Randomized controlled) 1000
4 Important to serious conjunctivitis
Follow up: 1 month. ( CI 95% 38 fewer 5
— 83 more ) indirectness
Chlamydial Relative risk 0.96 15 14 Very low

Due to serious risk We are uncertain whether
conjunctivitis (CI 95% 0.57 — 1.61) per 1000 per 1000 of bias, Due to routine antibiotic
1 month Based on data from 4,874
serious prophylaxis increases or
participants in 2 studies. Difference: 1 fewer per 1000 imprecision, Due decreases Chlamydial
(Randomized controlled) ( CI 95% 6 fewer to serious
5 Important conjunctivitis
Follow up: 1 month. — 9 more ) 6
indirectness
Bacterial
conjunctivitis
6 5 Very low We are uncertain whether
(Conjunctivitis Due to serious risk routine antibiotic
(CI 95% 0.37 — 1.93)
due to any of bias, Due to prophylaxis increases or
Based on data from 3,685 Difference: 1 fewer per 1000 serious decreases bacterial
bacteria) participants in 2 studies. ( CI 95% 4 fewer imprecision, Due conjunctivitis
1 month (Randomized controlled) — 6 more ) to serious (conjunctivitis due to any
Follow up: 1 month. 7
indirectness bacteria)
6 Important
Conjunctivitis Relative risk 0.65 67 44 Low Routine antibiotic

due to any (CI 95% 0.54 — 0.78)
per 1000 per 1000 Due to serious risk prophylaxis may decrease
aetiology (based Based on data from 9,666
of bias, Due to conjunctivitis due to any
on clinical participants in 8 studies.
Difference: 23 fewer per serious aetiology (based on
assessment) (Randomized controlled) 1000 8
indirectness clinical assessment)
1 month Follow up: 1 month. ( CI 95% 31 fewer
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Summary
— 15 fewer )
6 Important
Conjunctivitis of
unknown
18 32 Very low We are uncertain whether
aetiology Due to serious risk routine antibiotic
(CI 95% 0.37 — 8.28)
(culture-negative of bias, Due to prophylaxis increases or
Based on data from 330 Difference: 14 more per 1000 very serious decreases conjunctivitis
conjunctivitis) participants in 1 studies. ( CI 95% 11 fewer imprecision, Due of unknown aetiology
1 month (Randomized controlled) — 131 more ) to serious (culture-negative
Follow up: 1 month. 9
indirectness conjunctivitis)
6 Important
Nasolacrimal Relative risk 0.93 30 28 Very low

Due to serious risk We are uncertain whether
duct obstruction (CI 95% 0.68 — 1.28) per 1000 per 1000 of bias, Due to routine antibiotic
1 month Based on data from 404
serious prophylaxis increases or
participants in 1 studies. Difference: 2 fewer per 1000 indirectness, Due decreases nasolacrimal
(Randomized controlled) ( CI 95% 10 fewer to serious
6 Important duct obstruction
Follow up: 1 month. — 8 more ) 10
imprecision
0 0 Very low
Due to serious risk
Relative risk 0 per 1000 per 1000
Keratitis of bias, Due to
(CI 95% 0 — 0) We are uncertain whether
1 month serious
Based on data from 40 Difference: 0 fewer per 1000 routine antibiotic
inconsistency, Due
participants in 1 studies. ( CI 95% 0 fewer prophylaxis increases or
to serious
6 Important (Randomized controlled) — 0 fewer ) decreases keratitis
indirectness, Due
Follow up: 1 month. to very serious
11
imprecision
1. None of the RCTs reported this outcome.

5. Risk of Bias: serious. Inconsistency: no serious. Indirectness: serious. Imprecision: very serious.
6. Risk of Bias: serious. Inconsistency: no serious. Indirectness: serious. Imprecision: serious.
8. Risk of Bias: serious. Inconsistency: no serious. Indirectness: serious. Imprecision: no serious.
9. Risk of Bias: serious. Inconsistency: no serious. Indirectness: serious. Imprecision: very serious.
11. Risk of Bias: serious. Inconsistency: serious. Indirectness: serious. Imprecision: very serious.
51 of 103
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11. Among healthy neonates weighing >1800 g, are post-discharge home visits by a
healthcare worker superior to no home visits?
In most health facilities in India, both in the Government and private sectors, the mother and baby get discharged within 24 to 48
hours after delivery. Care of the young newborn at home is challenging, more so for primigravida mothers. Mothers and other
caregivers at home may not know appropriate ways of newborn care and may not be able to identify early signs of neonatal illnesses
such as dehydration, inadequate weight gain, and sepsis. Though post-discharge hospital visits are performed, they are few (one or
two visits in the first 4-6 weeks) and the amount of time spent with each mother-infant dyad during hospital visits is less. Further,
post-discharge hospital visits may not be possible for those living in remote and rural areas.
Post-discharge home visits, especially in resource-limited settings, are an integral part of postpartum care in many countries across the
world. A trained health-care worker usually performs home visits. During the home visit, the health-care worker assesses newborn
health and educates the mother regarding various aspects of newborn care and breastfeeding. In India, under the National Health
Mission (NHM), trained health-care workers named Accredited Social Health Activists (ASHA) perform home visits. Our practice
question was to evaluate if home visits by a designated healthcare worker are superior to no home visits.
The research evidence is derived from a meta-analysis conducted by the CPG group, which included 15
trials [21][169][170][171][172][173][174][175][176][177][178][179][180][181][182]. The trials were retrieved from two
previous systematic reviews [183][184] and an updated search conducted by the group.
Designated healthcare workers should conduct regular home visits to assess the health of the neonate and provide health
education to the family.
Research evidence
Post-discharge home visits by a trained health care worker reduce neonatal mortality (RR 0.73, 95% CI 0.67 - 0.79; moderate
certainty evidence) and infant mortality (RR 0.76, 95% CI 0.69 - 0.83; high certainty evidence). Post-discharge home visits may
have no effect on need for hospital admission (RR 1.20, 95% CI 0.71 - 2.02; low certainty evidence) and need for emergency
hospital visits (RR 1.06, 95% CI 0.91 - 1.24; low certainty evidence). Post-discharge home visits also improve exclusive
breastfeeding rate at 2-4 weeks (RR 1.08, 95% CI 1.05 - 1.11; high certainty evidence) and probably improve exclusive
breastfeeding rate at 2-4 months (RR 1.45, 95% CI 1.17 - 1.81; moderate certainty evidence). However, no effect has been
observed on any breastfeeding at 2-4 weeks (RR 1.00, 95% CI 0.96 - 1.04; low certainty evidence), any breastfeeding at 2-4
months (RR 1.02, 95% CI 0.99 - 1.05; low certainty evidence) and any breastfeeding at 6 months (RR 0.92, 95% CI 0.83 - 1.03;
low certainty evidence).
There is an existing national programme in India for post-discharge home visits. As part of the National Health Mission, the
Home-Based Newborn Care (HBNC) programme was launched in India in 2011 in low-resource settings to reduce neonatal
mortality. The health worker under this programme was named Accredited Social Health Activist (ASHA). She makes 6 home
visits on days 3, 7, 14, 21, 28 & 42 after birth for institutional deliveries and 7 home visits (one extra visit on day 2) for home
deliveries. During each home visit, ASHA will assess the newborn health and educate the mother on newborn care and
breastfeeding.
Home-Based Care for Young Child (HBYC) was launched in 2018 in India for the promotion of nutrition, growth, and early
development of the child during 3-15 months of age. ASHA provides 5 home visits at months 3, 6, 9, 12 and 15. During each
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visit, ASHA will counsel the mother for breastfeeding and complementary feeding, identify early growth and development
problems, manage minor illnesses, and refer sick children to health facilities.
Summary
There is high to moderate certainty of evidence that post-discharge home visits by health workers significantly reduce neonatal
and infant mortality and improve exclusive breastfeeding rates. No potential harms of home visits were observed. Since we
already have a national programme in place with designated health care worker to do home visits, and that evidence suggests
home visits significantly reduce neonatal and infant mortality, this CPG group recommends routine home visits post-
discharge.
The critical outcomes for this PICO are neonatal mortality and infant mortality.Moderate certainty evidence suggests routine
home visits reduce neonatal mortality. High certainty evidence suggests routine home visits reduce infant mortality. Overall
certainty of evidence for beneficial effects is moderate.
Research evidence
Since there is clear evidence suggesting that home visits reduce neonatal and infant mortality, both being
critical outcomes of health, we do not expect any variability in values and preferences among the
stakeholders such as policy makers, health care professionals and parents.
None
Research evidence
Evidence suggests that introduction of ASHA workers in India has significantly reduced neonatal mortality and that it is cost-
effective . A coverage rate of 54 percent of the population will avert 89,000 neonatal deaths (95 CI 44,200 to 149,100), while a
coverage rate of 83% will avert 138,000 neonatal deaths (95% CI 76,400 to 244,100). The financial benefits of the estimated
health reductions were significantly large as well. At US$108.97 for newborn intensive care, the Out-Of-Pocket expenditures
averted by the care package amount to US$66 million (95% CI $35 million to $106 million) at 54% coverage and US$102
million (95% CI $51 million to $182 million) at 83% coverage.
A renumeration of Rs. 250 is given to the ASHA worker when she completes 6-7 home visits for a neonate in the first 42 days.
Similarly, a renumeration of Rs. 250 is given when she completes 5 home visits for a young child between 3 and 15 months.
The training of ASHA workers, her travel and the ASHA kit are the additional costs incurred.Since home visits reduce mortality
and serious morbidity in neonates and young children, and thus save significant health-care costs, the program was found to
be cost-effective.
Summary
The human resource (ASHA) is already in place and it needs to be scaled up further to improve the coverage.
The programme was found to be significantly cost-effective.
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Research evidence
None
Since Home-Based Newborn Care and Home-Based care of Young Child are programmes implemented in
resource-limited settings such as rural and remote areas, where access to care is largely unavailable or
located far away, the programme will promote equity of health care.
Research evidence
None
Since home visits reduce the critical outcomes of neonatal mortality and infant mortality, it would be acceptable to all the
stakeholders such as policy makers, health-care professionals, and parents.
Summary
Given the significant benefits, routine post-discharge home visits will be acceptable to all the stakeholders.
Research evidence
None
Human resources for home visits are already in place in India. They need to be scaled up further to increase the coverage.
Summary
Since ASHA workers are already available, post-discharge home visits is a feasible intervention
Rationale
Moderate to high certainty evidence suggests post-discharge home visits reduce neonatal mortality and infant mortality, and
improve exclusive breastfeeding rates at 2-4 weeks and at 2-4 months. There is no potential harm due to the intervention. Hence,
the overall certainty of evidence is moderate and is favoring the intervention.There will not be any variability in values and
preferences among the key stakeholders and the intervention is likely to promote health equity.Since the national programme is
already in place with trained ASHA workers doing the home visits, the resources are already available and the intervention is
feasible. It needs to be scaled up further to ensure universal coverage.
Population: Stable newborn infants after discharge from hospital

Intervention: Home visit(s) by designated personnel
Comparator: No home visit
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Outcome Study results and Comparator Home visit(s) by the Evidence
Summary
Timeframe measurements No home visit designated (Quality of
personnel evidence)

Neonatal (CI 95% 0.67 — 0.79)
per 1000 per 1000 Home visit(s) by
mortality Based on data from Moderate
designated personnel
62,571 participants in 9 Due to serious
Difference: 10 fewer per 1 probably decreases
studies. (Randomized 1000 inconsistency neonatal mortality
Follow up: 28 days. — 8 fewer )

(CI 95% 0.69 — 0.83)
per 1000 per 1000
Infant mortality Based on data from Home visit(s) by
High
29,462 participants in 3 designated personnel
Difference: 15 fewer per 2
studies. (Randomized 1000 decreases infant mortality
Follow up: 1 year. — 10 fewer )
Need for Relative risk 1.2 19 23 Low Home visit(s) by

hospital (CI 95% 0.71 — 2.02) per 1000 per 1000 Due to serious risk designated personnel
admission Based on data from 2,690 of bias, Due to may have little or no
participants in 3 studies. Difference: 4 more per 1000 serious difference on need for
(Randomized controlled) ( CI 95% 6 fewer imprecision
3 hospital admission
— 19 more )
Need for Relative risk 1.06 215 228 Low Home visit(s) by
emergency (CI 95% 0.91 — 1.24) per 1000 per 1000 Due to serious risk designated personnel
hospital visits Based on data from 2,177 of bias, Due to may have little or no
participants in 2 studies. Difference: 13 more per 1000 serious difference on need for
(Randomized controlled) ( CI 95% 19 fewer imprecision
4 emergency hospital visits
— 52 more )
Any Relative risk 1 737 737 Low

Home visit(s) by
breastfeeding at (CI 95% 0.96 — 1.04) designated personnel
per 1000 per 1000 Due to serious risk
Based on data from 2,870 may have little or no
2-4 weeks of bias, Due to
participants in 4 studies. difference on any
Difference: 0 fewer per 1000 serious
(Randomized controlled) breastfeeding at 2-4
( CI 95% 29 fewer imprecision
5
Follow up: 2-4 weeks. weeks
— 29 more )
Any Relative risk 1.02 763 778 Low

Home visit(s) by
Based on data from 3,279 may have little or no
2-4 months of bias, Due to
Difference: 15 more per 1000 serious
6
Follow up: 2-4 months. months
— 38 more )
Any Relative risk 0.92 517 476 Low Home visit(s) by

breastfeeding at (CI 95% 0.83 — 1.03) per 1000 per 1000 Due to serious risk designated personnel
56 of 103
Outcome Study results and Comparator Home visit(s) by the Evidence
Summary
Timeframe measurements No home visit designated (Quality of
personnel evidence)
6 months Based on data from 943 may have little or no

Difference: 41 fewer per of bias, Due to
1000 serious
(Randomized controlled) 7 breastfeeding at 6
Follow up: 6 months. months
— 16 more )
Exclusive Relative risk 1.08 770 832 Home visit(s) by

per 1000 per 1000
Based on data from 5,085 probably improves the
2-4 weeks High
participants in 3 studies. rate of exclusive
Difference: 62 more per 1000
( CI 95% 39 more
Follow up: 2-4 weeks. weeks slightly
— 85 more )
Exclusive Relative risk 1.45 202 293 Home visit(s) by

per 1000 per 1000 Moderate
Based on data from 1,014 probably improves the
2-4 months Due to serious risk
participants in 2 studies. rate of exclusive
Difference: 91 more per 1000 of bias
8
( CI 95% 34 more
Follow up: 2-4 months. months slightly
— 164 more )
1. Inconsistency: serious. The magnitude of statistical heterogeneity was high, with I^2 79%. Indirectness:
no serious. Imprecision: no serious. Publication bias: no serious.
2. Inconsistency: no serious. Though I^2 value is 71%, it is only due to small and large effect sizes..
3. Risk of Bias: serious. Some concerns in all three included studies. Inconsistency: no serious.
Indirectness: no serious. Imprecision: serious. Small event rate. Publication bias: no serious.
4. Risk of Bias: serious. Some concerns in both included studies. Inconsistency: no serious. Indirectness:
no serious. Imprecision: serious. Small sample size. Publication bias: no serious.
5. Risk of Bias: serious. Some concerns in all 4 included studies. Inconsistency: no serious. Indirectness:
no serious. Imprecision: serious. Small sample size. Publication bias: no serious.
6. Risk of Bias: serious. Some concerns in all included studies. Inconsistency: no serious. Indirectness: no
serious. Imprecision: serious. Small sample size. Publication bias: no serious.
7. Risk of Bias: serious. Some concerns in all included studies. Inconsistency: no serious. Indirectness: no
serious. Imprecision: serious. Small sample size. Publication bias: no serious.
8. Risk of Bias: serious. Some concerns in both included studies. Inconsistency: no serious. Indirectness:
no serious. Imprecision: no serious. Publication bias: no serious.
57 of 103
12. Among healthy neonates weighing >1800 g, is purposive sunlight exposure superior
to no sunlight exposure?
About 60-80% of neonates develop physiological hyperbilirubinemia. One in ten neonates develops significant jaundice and needs
phototherapy. Severe jaundice, defined as serum total bilirubin of more than 20 mg/dL is the seventh most common cause of early
neonatal mortality globally. Bilirubin-induced neurological dysfunction (BIND), which comprises Acute Bilirubin Encephalopathy (ABE)
and Kernicterus Spectrum Disorder (KSD) occurs in 0.2-2.7 per 100000 live births in low- and middle-income
countries.[[185] Phototherapy is the standard of care for the management of neonatal hyperbilirubinemia .[186]
Considering the lack of universal access to healthcare facilities in LMIC, limited resources, lack of trained personnel,
and then the huge burden of severe jaundice alternative[187] and biologically plausible treatment would be natural
sunlight exposure. Sunlight is abundantly available across India across all season, its cost-effective and has other
health benefits of increasing Vitamin D levels during pregnancy and in children.[188] Nonetheless, it is not devoid
of adverse effects like ultraviolet radiation, sunburn, hyperthermia, dehydration, and risk of
malignancy.[189][190] Filtered sunlight has shown promising results in African studies to reduce the severity of
jaundice and as an alternative treatment to phototherapy.[191][192]
This PICO question aimed to address the role of sunlight exposure in stable-term and preterm infants in reducing
the incidence of jaundice .
Neonates may not be placed under direct sunlight due to a lack of robust evidence on its benefits and a lack of data on safety.
Desirable outcomes
There was only one study [193] reporting on one of the five critical outcomes. The risk of jaundice after sunlight exposure was
reduced by 39% (NNT - 7). The certainty of the evidence was very low for the reported outcome.
Undesirable outcomes
No studies were available that reported undesirable effects of sunlight exposure including hyperthermia, sunburn, risk of
dehydration, or long-term effects like risk of malignancy. However, exposure to ultraviolet rays in the sunlight has been
conclusively associated with an increased risk of skin cancer.
Overall judgment
It is biologically plausible to expose stable infants to sunlight's possible benefits of reduction of bilirubin levels and
improvement in Vitamin D levels and it is highly cost-effective in the Indian context. However, the lack of safety studies and
marginal proven benefits in clinical studies mandates against its routine use for parents.
There is no evidence for four of the five most critical outcomes. There is significant reduction in the incidence of jaundice on
exposure to sunlight (twice daily for 30-60 minutes) from the lone clinical study. The evidence was downgraded due to very
serious risk of bias and serious imprecision to very low certainty.
58 of 103
There is high variability in practice among parents and prescription among pediatricians or neonatologist on exposure to
routine sunlight. Exposure to routine sunlight should be accepted well, considering its possible health benefits and also being
free to cost
Sunlight is universally available, need for additional resources is not a consideration to make final decision
Universal availability of natural sunlight makes it affordable and easily available across all states in the Indian context.
Generally, exposure to sunlight is a routine practice in the Indian context. Many parents expose their babies to routine sunlight
after discharge, discounting the seasonal variations. About 67% of mothers expose their babies for jaundice in the tribal
community of Tamil Nadu.[124]
The intervention of exposure to sunlight is very feasible to implement because it requires no resources and is universally
available.
Population: Stable Newborns

Intervention: Sunlight Exposure
Comparator: No Sunlight Exposure
Certainty of
Comparator Intervention
Outcome Study results and the Evidence
No Sunlight Sunlight Summary
Timeframe measurements (Quality of
Exposure Exposure
evidence)
Acute Bilirubin
Relative risk 0 0
Encephalopathy No studies found
per 1000 per 1000
evaluating the outcome
9 Critical CI 95% 0 fewer —
Incidence of
Relative risk 0.61
(CI 95% 0.45 — 0.82)
354 216 Very low
Due to very
Babies exposed to
sunlight may have a
59 of 103
Certainty of
Exposure Exposure
evidence)
jaundice - per 1000 per 1000

Sunlight (with or
without filters or Difference: 138 fewer per reduced occurrence of
amplification) Based on data from 482 1000 serious risk of bias, jaundice in babies
versus no participants in 1 studies.
2 ( CI 95% 195 fewer Due to serious exposed to sunlight
1 (Randomized controlled) — 64 fewer ) imprecision
3
compared to babies who
treatment
were not treated.
9 Critical
Relative risk
Mortality
4 0 0
Based on data from 0
9 Critical participants in 0 studies.
CI 95%
Follow up: 0.
Need for
Conventional
0 0
Relative risk per 1000 per 1000
Phototherapy No studies found
CI 95%
9 Critical
Sunburn
5
Relative risk 0 0
per 1000 per 1000 No studies found
6 Important
CI 95% 0 fewer —
Hypothermia
(mild, moderate
0 0
or severe)
CI 95% 0 fewer —
6 Important
Need for Double

volume
0 0
exchange No studies were found
transfusion CI 95% evaluating the outcome
9 Critical
Rate of
rehospitalization
83 46 Very low
There was no reduction in
Relative risk 0.55 Due to serious risk
per 1000 per 1000 readmission to hospital
- Sunlight (with (CI 95% 0.27 — 1.11) of bias, Due to
for jaundice in babies
or without filters Based on data from 482 Difference: 37 fewer per
very serious risk of
exposed to sunlight
or amplification) participants in 1 studies. 7 1000
bias, Due to
compared to babies who
versus no (Randomized controlled) serious
( CI 95% 61 fewer 8 were not treated.
treatment
6
— 9 more ) imprecision
60 of 103
Certainty of
Exposure Exposure
evidence)
6 Important
Hyperthermia
9
Relative risk 0 0
per 1000 per 1000 No studies found
6 Important
CI 95%
Cessation of
10 Relative risk 0 0
Breastfeeding No studies found
per 1000 per 1000
6 Important CI 95% 0 fewer —
Vitamin D levels
11 Relative risk 0 0
in blood No studies found
per 1000 per 1000
6 Important CI 95% 0 fewer —
Duration of Difference: MD 2.2 lower

jaundice (days) - ( CI 95% 2.6 lower
— 1.8 lower ) Very low
Sunlight (with or Babies exposed to
Due to very
without filters or serious risk of bias,
sunlight may be
amplification) Based on data from 482 jaundiced for fewer days
Due to serious
versus no participants in 1 studies. compared to babies who
12 imprecision, Due
(Randomized have no preventive
treatment to serious
controlled) 13 treatment for jaundice.
publication bias
6 Important
1. A serum bilirubin level of 257 μmol/L (15mg/dl) to 291 μmol/L (17mg/dl) indicated a diagnosis of
jaundice,
2. Systematic review [194] with included studies: Xiao 2009. Baseline/comparator: Control arm of reference
used for intervention.
3. Risk of Bias: very serious. Single center, unblinded study of 482 infants; downgraded twice for very
serious study limitations (due to high risk of bias) and once for imprecision.. Inconsistency: no serious.
Indirectness: no serious. Imprecision: serious. Single center, unblinded study of 482 infants; downgraded
twice for very serious study limitations (due to high risk of bias) and once for imprecision.. Publication bias:
no serious.
4. Not measured
5. Not recorded
6. A value above the upper limit (291 μmol/L or above 17mg/dl) required hospital admission,
7. Systematic review [194] with included studies: Xiao 2009. Baseline/comparator: Control arm of reference
used for intervention.
serious study limitations (due to high risk of bias) and once for imprecision., Inadequate/lack of blinding of
61 of 103
participants and personnel, resulting in potential for performance bias, Inadequate/lack of blinding of
outcome assessors, resulting in potential for detection bias. Inconsistency: no serious. Indirectness: no
serious. Imprecision: serious. Single center, unblinded study of 482 infants; downgraded twice for very
serious study limitations (due to high risk of bias) and once for imprecision., Only data from one study, Wide
confidence intervals. Publication bias: no serious.
9. Not recorded
10. Not recorded
11. Not recorded
12. Systematic review [194] with included studies: Xiao 2009. Baseline/comparator: Control arm of
serious study limitations (due to high risk of bias) and once for imprecision.. Inconsistency: no serious.
Indirectness: no serious. Imprecision: serious. Single center, unblinded study of 482 infants; downgraded
twice for very serious study limitations (due to high risk of bias) and once for imprecision.. Publication bias:
no serious.
62 of 103
13. Among healthy neonates weighing >1800 g, is bathing with soap superior to bathing
without soap?
Despite the abundant literature on the timing and methods of application of cleaning products, there is a lack of consensus on what
constitutes an appropriate cleansing practice for neonates. Most guidelines by global and regional organizations on neonatal care fail
to provide guidance regarding the type of cleanser to be used. [195][196][197]Whether application of cleanser is associated with any
added benefits or harms is unknown.
The skin of infants is remarkably different from the skin of adults. At birth, skin pH is almost neutral (pH 6.2–7.5), reaching adult levels
(pH 5.4–5.9) after a few weeks. During the first months and even years, the skin continues to develop and evolve its structure and
functions. Special care procedures are required to ensure optimal development and protection of the skin from inflammation and
development of eczema. High skin surface pH has been related to higher rates of bacterial proliferation and higher activity of
proteolytic enzymes that are detrimental to the skin barrier function. [198] To assess the effect of soap application in stable newborns,
we conducted a systematic review of the available literature. The objective was to evaluate the quality of evidence available and frame
guidance for families.
Soap may not be used for bathing healthy term neonates during the first 4 weeks of life.
However, soap should be used for cleansing the visibly soiled skin of the neonate at home. Parents and other caregivers should
use soap and water for hand hygiene (Good Clinical Practice in accordance with the WASH guidelines).
Research evidence
No RCTs have looked at critical outcomes of mortality, neonatal sepsis, the occurrence of eczema or atopy in later life, and
hypothermia following soap application compared to no soap application in stable newborns. However, the included studies
evaluated the surrogate or intermediate outcomes in terms of alteration in barrier function of skin. Skin hydration and
2
transepidermal water loss were measured using a corneometer and an Aquaflux device in g/m /h. [199][200] Change in
eythema was expressed as log erythema units (arbitrary) and skin pH was determined using a pH meter. For dermatitis, a skin
assessment scale was also used to categorise severity of skin abnormality in terms of redness, dryness, and excoriation,
evaluated across various body parts like buttocks, thighs, and forehead.
Six RCTs show significant variability in the method (wash vs wipe), soap (alkaline, neutral, or mildly acidic pH), and site and
timing of assessment (1 day to 8 weeks). From surrogate outcomes, it appears that soap doesn't confer any significant benefits
or harms in terms of skin colonization, alterations in skin dryness or erythema, or abnormal skin condition scores. There is weak
evidence of lower trans-epidermal water loss and slightly higher pH in neonates who were applied soap, compared to no soap,
during routine cleansing. (Very low certainty evidence)
Soap application for bathing in stable-term newborns did not confer any significant additional benefits or harms in any
newborn or infant critical outcomes.
Summary
Soap application did not have any significant beneficial or harmful effect on infant or newborn outcomes.
63 of 103
Research evidence
The critical outcomes have not been reported in literature, resulting in downgrading of the available evidence. Randomized
studies that evaluated the effect of soap application assessed intermediate outcomes like skin dryness, redness, dermatitis, pH,
and trans-epidermal water loss (TEWL). Although reported consistently across studies, these outcomes do not necessarily
reflect any significant correlation with critical outcomes like eczema. Alteration in skin colonization was determined in two
studies, with variable results and insufficient details to consolidate information regarding any significant effect on colonization,
and perhaps neonatal sepsis. One study was commercially funded by soap company, raising concerns of conflicts of
interest. [201]
Summary
The included studies did not evaluate the critical outcomes of neonatal mortality, sepsis, and eczema. Due to indirectness of
outcomes reported by these studies, and serious risk of bias resulting from small sample size and concerns in methodology,
the overall certainty of evidence was graded as low to very low.
Research evidence
Limited studies report variable results on practices related to bathing and use of soap or cleanser for a
newborn. [202][203]The study in Nepal evaluated usage and preference of soap use by women in community for neonates. It
was observed that 1% of the first bath of newborns was performed using soap and wash. (only 4% mothers used soap and
water bath for the first 2 weeks of life. [203]To assess the community practices in Africa related to skin care of newborns, a
narrative review was conducted using in-depth interviews in 4 sites. Across all sites, the vernix was believed to be dirty and was
intended to be removed as early as possible after birth. One woman reported that her baby was being cleaned using coconut
oil and cotton sponge followed by bathing with warm water and soap. [202]The type of soap however was not discussed in
the study.
We did not find any studies that reported the choice of cleanser or soap for bathing a newborn.
Summary
There is a dearth of literature on the values and preferences of families regarding the use of soap for skin care of their
newborns, However, it appears that there are conflicting practices in the communities (based on 2 studies). Where some
mothers would prefer to thoroughly cleanse (possibly with soap) the newborn skin to eliminate vernix, others prefer to use
only water to bathe their newborn.
Research evidence
Important issues like cost-effectiveness have not been addressed in studies.
Summary
Important issues like cost-effectiveness have not been addressed in studies.
Research evidence
No data available for equity of the intervention.
64 of 103
None
Summary
With no additional benefit with use of soap (Very low COE) and possible but unreported higher costs and availability to only
high socio-economic strata, the guideline group recommends against the routine use of soap for bathing of stable term
infants.
Research evidence
A study on 606 neonates suggested that parents reported increased satisfaction level during the study, and
pediatricians declared that the products used were without secondary effects on the body skin of newborn children, especially
in 186 newborns (92 female, 94 males) aged 0-4 weeks. [204]
Summary
Soap application is acceptable (evidence from a single observational study). However, the type of soap used
(e.g, pH adjusted, hypoallergenic soap etc), families' preferences, and cultural beliefs would determine the
acceptability of different products.
The guideline group recommends against the routine use of soap for bathing of stable term infants due to possible cost
implications (although modest) at the community level.
Population: Stable newborns

Intervention: Soap application
Comparator: No soap application
Certainty of
No soap Soap Summary
application application
evidence)
Neonatal sepsis Relative risk 0 0 No studies were found

per 1000 per 1000 that looked at neonatal
9 Critical sepsis
Moderate to
severe 0
0 0 No studies were found
that looked at moderate
(0 — 0) per 1000 per 1000 to severe hypothermia.
hypothermia
Based on data from 0 Indirect evidence by
Difference: 0 fewer per 1000 continuous outcomes like
9 Critical TEWL.
65 of 103
Certainty of
evidence)
30 30 Very low
Due to serious risk
per 1000 per 1000 of bias, Due to
serious
Difference: 0 fewer per 1000 inconsistency, Due
( CI 95% 0 fewer to serious
— 0 fewer ) Soap application may
imprecision, Due
Relative risk 1 have little or no
28-day Mortality to serious
(CI 95% 1 — 1) difference on 28-day
inconsistency, Due
Based on data from 1,234 mortality We are
1 to serious
9 Critical participants in 5 studies. uncertain whether soap
indirectness, Due
(Randomized controlled) application improves or
to serious
worsen 28-day mortality
imprecision, Due
to serious
publication bias,
Due to very
serious risk of bias
2
Odds ratio 0.89 11 10 Low

Due to serious risk
Skin erythema (CI 95% 0.44 — 1.81) per 100 per 100 Soap application may
of bias, Due to
Based on data from 933 have little or no
3 serious
participants in 3 studies. Difference: 1 fewer per 100 difference on skin
6 Important inconsistency, Due
(Randomized controlled) ( CI 95% 6 fewer erythema
to serious
Follow up: 8 weeks. — 9 more ) 4
imprecision
430 378 Very low

Due to serious risk
Relative risk 0.88 per 1000 per 1000 of bias, Due to
5 We are uncertain whether
Colonisation (CI 95% 0.42 — 1.83) serious
Difference: 52 fewer per soap application
Based on data from 32 inconsistency, Due
6 1000 improves or worsens skin
4 Important participants in 1 studies. to serious
( CI 95% 249 fewer indirectness, Due colonisation.
— 357 more ) to serious
7
imprecision
0 0 Very low
Due to serious risk
per 1000 per 1000 of bias, Due to
serious
Relative risk 0 Difference: 0 fewer per 1000 There were too few who
Mild (CI 95% 0 — 0)
inconsistency, Due
( CI 95% 0 fewer experienced the mild
hypothermia to serious
Based on data from 100 — 0 fewer ) hypothermia, to
8 indirectness, Due
participants in 1 studies. determine whether soap
to very serious
4 Important (Randomized controlled) application made a
indirectness, Due
Follow up: After bath. difference
to serious
imprecision, Due
to very serious
9
imprecision
Skin dryness
Odds ratio 1.71
(CI 95% 0.87 — 3.36)
11 19 Low
Due to serious risk
Soap application may
have little or no
Based on data from 933 per 100 per 100 of bias, Due to difference on skin dryness
66 of 103
Certainty of
evidence)
10 Difference: 8 more per 100 serious
(Randomized 11
6 Important ( CI 95% 1 fewer indirectness
controlled)
— 25 more )
Odds ratio 0.74 16 12 Very low

Due to serious risk
Dermatitis (CI 95% 0.37 — 1.47) per 100 per 100 We are uncertain whether
of bias, Due to
Based on data from 892 soap application
serious publication
participants in 3 studies. Difference: 4 fewer per 100 improves or worsens
6 Important 12 bias, Due to
(Randomized ( CI 95% 10 fewer dermatitis
serious
controlled) — 7 more ) 13
indirectness
Eczema 0 0 0 No studies were found

per 1000 per 1000 that looked at the effect
(0 — 0)
of soap application vs no
Based on data from
6 Important Difference: 0 fewer per 1000 soap application on
development of eczema
0 fewer — 0 fewer
Proportion of
neonates with
Odds ratio 0.72
(CI 95% 0.41 — 1.26)
16 12 Low Soap application may
Based on data from 386 per 100 per 100 Due to serious risk
abnormal skin have little or no
participants in 3 studies. of bias, Due to difference on proportion
score 14 Difference: 4 fewer per 100
(Randomized serious of neonates with
controlled) ( CI 95% 9 fewer 15 abnormal skin score.
indirectness
6 Important
Follow up: 4 weeks. — 4 more )
5.5 5.81 Very low

Due to serious
Measured by:pH meter (Mean) (Mean) inconsistency.,
Skin pH Lower better Soap application
Due to serious risk
Based on data from 728 Difference: MD 0.31 higher probably increases skin
of bias, Due to
participants in 5 studies. ( CI 95% 0.08 pH slightly (Very low
4 Important 16 serious
(Randomized higher — 0.53 certainty)
indirectness, Due
controlled) higher ) to serious
17
imprecision
Measured by:Hydration
37 36.2 Very low
Due to serious
scores using a Arbitrary units Arbitrary units inconsistency, Due
corneometer (Mean) (Mean) to serious
Skin hydration We are uncertain whether
High better indirectness, Due
Difference: MD 0.8 lower soap application
Based on data from 342 to serious
( CI 95% 2.96 improves or worsen skin
4 Important participants in 2 studies. imprecision, Due
18 lower — 1.36 hydration
(Randomized to serious risk of
controlled) higher ) bias, Due to
Follow up: 4 weeks. serious
19
inconsistency
Trans-epidermal Hygrometer
Measured by:
Lower better
13.1 12.2 Very low
Due to serious risk
soap application
water loss
67 of 103
Certainty of
evidence)
g/m2/h (Mean) g/m2/h (Mean) of bias, Due to

Based on data from 596 serious
participants in 3 studies. Difference: MD 0.91 lower inconsistency, Due improves or worsen
20 to serious
(Randomized ( CI 95% 1.69 trans-epidermal water
4 Important
controlled) lower — 0.14 indirectness, Due loss
Follow up: 4. lower ) to serious
21
imprecision
1. Systematic review [206] with included studies: Noviello 2005, Lavender 2011, Garcia Bartels 2010,
Lavender 2013, Lavender 2012. Mortality was not included as the outcome (primary or secondary) in any of
the included studies. The rates of mortality have been assumed based on no. of babies completing 28 days
follow up in a study. Baseline/comparator: Control arm of reference used for intervention[207]. From Tielsch
et al.
2. Risk of Bias: very serious. Trials stopping earlier than scheduled, resulting in potential for overestimating
benefits. Incomplete data and/or large loss to follow up. Inadequate/lack of blinding of participants and
personnel, resulting in potential for performance bias.. Inconsistency: serious. Not reported directly as
outcome in all studies.. Indirectness: serious. Not reported directly as outcome in all studies.. Imprecision:
serious. No event rate in included studies. Some studies only up to 2 weeks. May be difficult to comment. .
Publication bias: serious. One study was funded..
3. Systematic review [206] with included studies: Noviello 2005, Lavender 2013, Lavender 2011. Baseline/
performance bias Incomplete data and/or large loss to follow up. Inconsistency: no serious. 0%
hetergeneity and narrow CIs. Indirectness: no serious. Imprecision: serious. Only 2 studies, Low event rate.
5. Surrogate outcomes
6. Primary study[201]. Lavender: Coliform or candida colonies in diaper area. NA as dichotomous outcome..
7. Risk of Bias: serious. Incomplete data and/or large loss to follow up. Inconsistency: no serious. Only
two studies with different methods of outcome assessments.. Indirectness: serious. Differences between the
outcomes of interest and those reported (colony counts vs proportion of neonates who had colonisation),
Differences between the intervention/comparator of interest and those studied (one study soap vs water, and
other wipes on the buttock area).. Imprecision: serious. Only data from one study, Low number of patients.
8. Primary study[208]. Baseline/comparator: Primary study.
9. Inconsistency: serious. No other study, and this study too only temperature range.. Indirectness: very
serious. Direct comparisons not available. Imprecision: very serious. Only data from one study, Low
number of patients. Publication bias: no serious.
10. Systematic review [206] with included studies: Lavender 2013, Lavender 2011, Noviello 2005. Baseline/
for performance bias, Incomplete data and/or large loss to follow up. Inconsistency: no serious.
Indirectness: serious. Indirect for critical outcome of eczema (surrogate), . Imprecision: no serious.
12. Systematic review [206] with included studies: Garcia Bartels 2010, Noviello 2005, Lavender 2012.
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for performance bias, Incomplete data and/or large loss to follow up. Inconsistency: no serious.
Indirectness: serious. Differences between the outcomes of interest and those reported, surrogate for
eczema. Imprecision: no serious. Publication bias: serious. Mostly commercially funded studies.
14. Systematic review [206] with included studies: Lavender 2011, Garcia Bartels 2010, Lavender 2012.
Baseline/comparator: Control arm of reference used for intervention[200].
for performance bias, Incomplete data and/or large loss to follow up. Inconsistency: no serious. Point
estimates vary. Indirectness: serious. Surrogate outcome for development of physiological imbalance,
predisposing to eczema in later life. Imprecision: no serious. Publication bias: no serious. One study with
least weightage funded by J&J soap..
16. Systematic review [206] with included studies: Lavender 2013, Lavender 2012, Lavender 2011. Site of pH
measurement different and how to analyse? Garcia and Lund study, outcome not available for comparator
arm, only difference between two arms provided.. Baseline/comparator: Primary study[205].
17. Risk of Bias: serious. Missing intention-to-treat analysis, Inadequate/lack of blinding of participants and
personnel, resulting in potential for performance bias, Incomplete data and/or large loss to follow up.
Modified ITT and those missing not imputed.. Inconsistency: serious. The magnitude of statistical
heterogeneity was high, with I^2: 88 %., Point estimates vary widely (a small variation can make a large
difference in pH values). Indirectness: serious. Areas of measurement variable., Surrogate for skin balance
and physiological transition. Imprecision: serious. Wide confidence intervals. Publication bias: no serious.
18. Systematic review [206] with included studies: Lavender 2011, Lavender 2013. Baseline/comparator:
Primary study[205].
19. Risk of Bias: serious. Missing intention-to-treat analysis, Inadequate/lack of blinding of participants and
personnel, resulting in potential for performance bias, Incomplete data and/or large loss to follow up.
Inconsistency: serious. The confidence interval of some of the studies do not overlap with those of most
included studies/ the point estimate of some of the included studies.. Indirectness: serious. SCH is a
surrogate for hypothermia and eczema as critical outcome. Different areas of measurement.. Imprecision:
serious. Wide confidence intervals. Publication bias: no serious.
20. Systematic review [206] with included studies: Lavender 2013, Lavender 2012, Lavender 2011. Baseline/
comparator: Control arm of reference used for intervention[205]. The study provides baseline TEWL before
randomisation..
21. Risk of Bias: serious. One study with 9% lost to follow up.. Inconsistency: serious. The magnitude of
statistical heterogeneity was high, with I^2:82%.. Indirectness: serious. Differences between the outcomes
of interest (hypothermia) and TEWL, taken as surrogate.. Imprecision: serious. Wide confidence intervals.
69 of 103
14. Among healthy neonates weighing >1800 g, is sleeping in the supine position
superior to sleeping in a non-supine position (prone or side or changing positions)?
Despite a decline in the incidence, sudden infant death syndrome (SIDS) remains a major cause of infant mortality. Arousal from sleep
is an important survival mechanism that may be impaired in SIDS victims. A distinct peak in the incidence occurs at 2 to 3 months in
the incidence of SIDS, and a prone sleep position has been identified as a major risk factor. The prone position is associated with lower
blood pressure and impaired arousability from sleep, both of which may be signs of cerebral hypoxia. The GDG sought to evaluate if
sleeping in the supine position (I), compared with sleeping in the non-supine position (prone or side or changing positions) (C),
improves newborn and infant outcomes (O) among stable neonates (P).
Strong recommendation , Low certainty evidence
Healthy neonates should be placed in a supine position during sleep.
Research evidence
Low- to very low-certainty evidence suggests that a supine sleep position may reduce the risk of sudden infant death
syndrome. [209] [210] [211][212][213][214][215][216][217][218] The effect of supine sleep position was uncertain on
ALTE-related hospital admissions in the first 6 months of life. There might be an increase in the incidence of positional
plagiocephaly (at 2-7 months of age) due to a supine sleep position, compared to a non-supine
position. [219][220][221][222] [223]The evidence for most outcomes was of low- to very low-certainty, owing to a high risk
of bias (in observational studies), heterogeneity, and imprecision (where results were based on a single study). Neonatal
mortality was not reported in the included studies. Experience of postnatal care was not reported in the included studies.
The prone sleeping position has been identified as a major risk factor for SIDS. Prone sleeping has also been shown to increase
the duration of quiet sleep. Preliminary studies indicate that vasomotor tone is reduced in the prone position. On the other
hand, term neonates are more likely to have desaturation events in the supine position probably related to increased chances
of the tongue falling backward or due to gastroesophageal reflux which is more common in the supine
position. [224] However, cerebral oxygenation is depressed in healthy-term infants while sleeping prone. [225] [226] SIDS
occurs when the baroreflex is immature and under both sleep and stimulated conditions, sleep state has a marked effect on
baroreflex sensitivity and the effect of sleeping position is sleep state-dependent. [227] [228] [229][230][231][232]
Summary
Sleeping in the supine position may reduce the risk of sudden infant death syndrome, and may worsen deformational
plagiocephaly. Howvever, the evidence is rated as low- to very low- certainty evidence.
Certainty of the Evidence Low
Research evidence
The evidence for a reduction in the incidence of SIDS by placing the infant in a supine position emerges from 26 observational
studies. There was significant heterogeneity among the studies due to disparate study designs, geographical locations, and
different study periods. For critical outcomes like SIDS, the risk of bias was very serious, with serious inconsistency and possible
publication bias. Neonatal mortality and experience of postnatal care were not reported in the included studies.
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An analysis of trends in post-neonatal mortality and SIDS rates in Australia, Great Britain, the Netherlands, New Zealand,
Norway, Sweden and the USA between 1980 and 1992 found that countries that experienced a rapid decline in prone sleeping
also had reductions in SIDS rates of approximately 50%. [233]
A study evaluating the impact of the Back to Sleep campaign from 1990 to 2012 in Colorado, USA, also reported significant
decreases in SIDS incidence from 1.99/1000 live births in the pre-Back to Sleep era (1990-1993) to 0.57/1000 live births in the
post-Back to Sleep era (1997–2012) (P ≤ 0.001 for the trend) [234]
Summary
Low- to very low-certainty evidence suggested that supine sleep position might result in reduction of SIDS. There might be an
increase in the incidence of positional plagiocephaly (at 2-7 months of age) due to supine sleep position, compared to the
non-supine position.
No studies addressed the concerns of values and preferences of a family regarding the sleep position.
No direct evidence was identified on the impact on health equity of sleep position in term newborns without
complications.
Research evidence
A qualitative evidence synthesis of women’s
experiences of postnatal care found no direct
evidence relating to women’s views on infant sleeping positions. Indirect evidence from this review suggests
that most women appreciate advice and information from health workers about techniques that optimize
infant well-being (high confidence in the evidence). However, in some LMIC contexts, women may prefer to
adopt traditional newborn care practices during the immediate postpartum period
(moderate confidence in the evidence).
A qualitative evidence synthesis exploring decision-making for infant sleep environments among at-risk families identified key
issues that were prevalent among relatively deprived populations living in HICs. [235] Parents were reluctant to accept health
worker guidance on infant sleeping positions if they felt the advice was counter-intuitive or compromised their own experience
(e.g., placing infants in non-supine positions aids comfort, helps with breathing, or reduces the potential for choking). Parents
wanted information and advice explained to them along with supporting evidence rather than being told what to do in a
didactic manner.
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Research evidence
There is no direct evidence on the feasibility of sleeping in supine position; however, indirect evidence does suggest that a lack
of personnel, resources, and training may limit the provision of information and counseling on sleep position in term newborns
during the postnatal period (moderate confidence in the evidence).
Findings indicate that parents in these communities may not trust advice on sleeping positions given by health workers,
especially where it conflicts with information provided by trusted family members or community networks.
Summary
Indirect evidence suggests that a lack of personnel, resources, and training may limit the provision of information and
counseling on sleep position in term newborns during the postnatal period.
Rationale
Low- to very-low-certainty evidence suggests that a supine sleep position may reduce the risk of sudden infant death syndrome.
The effect of supine sleep position was uncertain on ALTE-related hospital admissions in the first 6 months of life. There might be
an increase in the incidence of positional plagiocephaly (at 2-7 months of age) due to the supine sleep position, compared to the
non-supine position. The evidence for most outcomes was of low- to very low-certainty, owing to a high risk of bias (in
observational studies), heterogeneity, and imprecision (where results were based on a single study). Neonatal mortality was not
reported in the included studies.
Population: Stable newborn

Intervention: Sleeping in supine position
Comparator: Sleeping in non-supine position
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Certainty of
Comparator
Outcome Study results and Intervention the Evidence
Non-supine Summary
Timeframe measurements Supine sleep (Quality of
sleep
evidence)
430 278 Low

Sudden infant Odds ratio 0.51 per 1000 per 1000 Due to very
death syndrome serious risk of bias, Supine sleep may
(CI 95% 0.42 — 0.61)
Due to serious decrease sudden infant
1
(Observational (non- Difference: 152 fewer per
inconsistency, Due death syndrome
9 Critical randomized)) 1000
to serious
( CI 95% 189 fewer 2
— 115 fewer ) publication bias
Odds ratio 2.77 690 860 Low

Positional (CI 95% 2.06 — 3.72) per 1000 per 1000 Due to very
plagiocephaly Supine sleep may
Based on data from 1,774 serious risk of bias
3 Difference: 170 more per increase the incidence of
participants in 6 studies. and non-
1000 positional plagiocephaly.
6 Important (Observational (non- randomised
randomized)) ( CI 95% 131 more studies.
4
— 202 more )
1. Primary study[240], [261], [254], [239], [256], [236], [245], [243], [262], [260], [255], [259], [244], [251], [246],
[218], [216], [252], [257], [241], [247], [242], [217], [253], [258], [248]. Baseline/comparator: Control arm of
2. Risk of Bias: very serious. Most of the pooled effect contributed by one study.. Inconsistency: serious.
The magnitude of statistical heterogeneity was high, with I^2 > 60%.. Indirectness: no serious. Imprecision:
no serious. Publication bias: serious. Asymmetrical funnel plot. Upgrade: large magnitude of effect.
3. Systematic reviewwith included studies: [223], [220], [222], [250], [221], [219]. Baseline/comparator:
4. Risk of Bias: very serious. Most of the pooled effect contributed by one study.. Inconsistency: no
serious. Indirectness: no serious. Imprecision: no serious. Publication bias: no serious.
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15. Among healthy neonates weighing >1800 g, is rooming in on the mother’s bed
superior to rooming in on a side crib?
Separation of the mother-baby dyad soon after birth raises many socio-cultural, psychological, and emotional concerns and has been
increasingly discouraged over the recent years. With the introduction of the concept of ‘rooming-in’ and its widespread incorporation
into national and international guidelines,[237] there is an urge to move towards ‘no separation’ of a newborn from the mother. This
holds true especially for stable newborns who do not require advanced care.
While it seems clear that mothers should be advised to room-in with their newborns, there is conflicting evidence to provide guidance
on the safest place to keep the newborn while roomed-in. The neonate can either share a bed with the mother, or be placed in an
attached side-car or side-cot, or a stand-alone cot in the same room. Although bed-sharing seems ‘ideal’ to allow for exclusive
breastfeeding, there are concerns regarding its association with an increased risk of sudden infant death syndrome (SIDS). A systematic
review suggested a significant increase in SIDS by 2.36 times in infants who were bed-shared. [263] Conversely, breastfeeding rates at
4-weeks were 3 times higher in bed sharing group. The evidence was rated as low certainty and based on observational studies
conducted in high income countries.
There is lack of any guidance for developing countries regarding the safest place to keep the newborns. To address this question, we
conducted a systematic review of the available literature. The focus was to delve into factors associated with increased risk of SIDS (as
the case may be) while in bed-sharing position and extract any guidance on the association with the type of bed surface and maternal
smoking.
Mother and neonate should be roomed-in soon after birth. However, while roomed-in, the mother and the neonate may not share
the same bed.
Benefits and harms Important harms
Research evidence
Low certainty evidence from non-randomized observational studies suggests that there is a definite harm in
terms of increased risk of sudden infant death syndrome if the baby is placed on the same bed as mother.
Breastfeeding duration was higher in neonates who bedshared in one case control study.[238] There are no
studies available that evaluate critical outcomes like neonatal mortality, sepsis, and hypothermia.
Summary
There are no randomised studies that could address the critical outcomes of interest. Results from
observational (case control) studies suggest an increased incidence of SIDS, with no difference in
desaturation or apneic episodes in neonates who bedshared with parents compared to those who didnot.
Research evidence
The evidence of critical outcomes related to bed sharing emerges from observational studies. We didnot find
any RCTs to address outcomes of interest. Although the sample size from these studies is substantial, the
incidence of outcomes like SIDS could be falsely inflated due to case-control design. These factors resulted
in a low to very low certainty of evidence.
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Research evidence
No studies available.
Research evidence
From the nature of the bedding-in process, it seems that there is no additional resource required.
Conversely, for a neonate who is not bedsharing, a standalone cot or a side car confers additional cost
(depending on the technical specifications of different designs and companies). With a very low CoE of an
increased risk of SIDS and no significant differences for other critical outcomes, bedding-in does seem to be
cost effective. However, further studies (preferably randomised) are warranted to address this issue.
Summary
From the nature of the bedding-in process, it seems that there is no additional resource required.
Conversely, for a neonate who is not bedsharing, a standalone cot or a side car confers additional cost
(depending on the technical specifications of different designs and companies). With a very low CoE of an
increased risk of SIDS and no significant differences for other critical outcomes, bedding-in does seem to be
cost effective. However, further studies (preferably randomised) are warranted to address this issue.
Research evidence
No studies available.
Summary
There are no studies available to establish safety and efficacy of bed sharing in different socio-economic
strata. All the eligible studies were conducted in high and upper middle income countries. A poor socio-
economic strata may determine the availability and quality of the additional equipment required for nursing
the newborn who doesnot share bed with the parents. A recommendation against bed sharing based on an
increased risk of SIDS can compel the underprivileged families to procure cots and side cars, probably
reducing equity.
Research evidence
No studies available
Feasibility Important issues, or potential issues not investigated
Nursing in a side car or cot seems feasible but its cost-effectiveness is uncertain. No direct or indirect
evidence relating to feasibility of the implementation of the intervention (no bedding in). However, indirect
evidence like non availability of resources, may limit implementation of the intervention on a large scale.
Population: Stable neonates

Intervention: Bedding-in
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Comparator: No bedding-in
Certainty of
Outcome Study results and Comparator Intervention the Evidence
Summary
Timeframe measurements No bedding-in Bedding-in (Quality of
evidence)
Incidence of
Relative risk 0.61 25 15 Low
(CI 95% 0.25 — 1.53) We are uncertain whether
1 per 100 per 100 Due to serious risk
apnea Based on data from 80 bedding-in improves or
2 of bias, Due to
participants in 1 studies. Difference: 10 fewer per 100 worsen incidence of
serious
(Observational (non- apnea
3
randomized)) — 13 more )
Relative risk 2.13

Sudden infant (CI 95% 1.9 — 2.38)
18 38 Low
per 100 per 100 Due to very
Based on data from 2,964 Bedding-in probably
death syndrome 4 serious risk of bias,
participants in 5 studies. worsens sudden infant
Difference: 20 more per 100 and no
(Observational (non- death syndrome
( CI 95% 16 more randomised study
randomized)) 5
— 25 more ) available
Follow up: 1 year.
Neonatal sepsis
0 0
0 No studies were found
per 1000 per 1000
(0 — 0) that looked at neonatal
Difference: 0 fewer per 1000 sepsis
0 fewer — 0 fewer
Need for re- 0 0

hospitalisation per 1000 per 1000
(0 — 0) that looked at need for
Difference: 0 fewer per 1000 re-hospitalisation
0 fewer — 0 fewer
Moderate to
severe
0 0
0 per 1000 per 1000 No studies were found
hypothermia (0 — 0) that looked at moderate
Difference: 0 fewer per 1000 to severe hypothermia
0 fewer — 0 fewer
Exclusive 0 0
Relative risk 0
breastfeeding (CI 95% 0 — 0)
that looked at exclusive
Based on data from 0
Difference: 0 fewer per 1000 breastfeeding
5 Important participants in 0 studies. ( CI 95% 0 fewer
— 0 fewer )
No studies were found

Length of
Lower better that looked at length of
hospital stay hospital stay
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Certainty of
Summary
Timeframe measurements No bedding-in Bedding-in (Quality of
evidence)
Maternal
bonding No trials were found that
looked at maternal
bonding
1. Desaturation < 80%

2. Primary study[264]. Only significant desaturation and apnea was considered. Baseline/comparator:
3. Risk of Bias: serious. Non randomised design. Inconsistency: no serious. Single study.. Indirectness:
no serious. Imprecision: serious. Only data from one study. Publication bias: no serious.
4. Primary study[266], [268], [270], [267], [265]. The evidence is based on a single retrospective comparative
study.. Baseline/comparator: Control arm of reference used for intervention[268], [270], [266], [267], [269],
[265].
5. Risk of Bias: very serious. Non randomised design. Inconsistency: no serious. Indirectness: no
serious. Imprecision: no serious. Non randomised design. Publication bias: no serious.
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16. Among healthy neonates weighing >1800 g and roomed in with the mother is
Kangaroo Mother Care (KMC) superior to a) no KMC or b) the use of other hypothermia
prevention measures/devices?
The short-term and long-term benefits of KMC in low birth weight babies are well known. There is a clear benefit of KMC over no KMC
(21 studies, 3042 infants) in terms of significant reduction in hypothermia, sepsis, mortality, and improvement in growth parameters
and rates of exclusive breastfeeding. [271] Given the evidence-based proven role of benefits of KMC, the efficacy of other
hypothermia prevention strategies (phase changing material, plastic wraps, thermal wraps, etc.) has not been systematically evaluated.
With this rationale, we conducted a systematic review to assess the efficacy of such strategies to prevent hypothermia in newborns, in
comparison to KMC[272][273].
Strong recommendation , Very low certainty evidence
Kangaroo Mother care (KMC) should be practiced to prevent hypothermia in stable neonates born with a birth weight of
1800-2500 g. KMC may be continued even after discharge to home.
Based on very low CoE, KMC is associated with significant reduction in hypothermic episodes as compared to conventional
care in a incubator for a low birth weight baby.
Research evidence
We found only one trial [274] that studied direct comparison of care in the kangaroo position versus incubator care in terms
of hypothermia reduction. Another observational study also reported hyperthermia episodes when nursed in incubator versus
KMC. No studies reported critical outcomes like sepsis, mortality, need for re-hospitalization, and duration of hospital stay.
Summary
Due to insufficient evidence on the critical outcomes with only one trial (n=29 patients) reporting
temperature recordings in conventional compared to KMC, the overall certainty of evidence for all critical
outcomes was rated as very low.
Research evidence
In a study by Roba et al, 349 mothers with low-birth-weight babies were interviewed to assess their knowledge and attitude
regarding KMC. Almost 70% of them knew the benefits of KMC and 63% felt positive about implementation of KMC and its
effect on breastfeeding. [276]
In another systematic review, 16 studies (12,345 respondents) reported kangaroo mother practice, with five (comprising 1,232
participants combined) reporting that both knowledge and attitude were used to determine the overall estimation. 64.62%
reported good knowledge and 61.55% reported positive attitude. [277]
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Summary
Mothers are likely to prefer KMC over other hypothermia prevention strategies due to its ease of implementation, cost-
effectiveness, and non separation from the mother.
Research evidence
Given the population of interest as bigger and stabler neonates, the cost-benefits will presumably be
significant but of a lesser magnitude as seen in sicker neonates. Implementation of KMC, therefore, seems
cost-effective in terms of technical and manpower requirements for its implementation.
None
Summary
Given the population of interest as bigger and stabler neonates, the cost-benefits will presumably be
significant but of a lesser magnitude as seen in sicker neonates. Implementation of KMC, therefore, seems
cost-effective in terms of technical and manpower requirements for its implementation.
Research evidence
No studies available to assess equity of KMC implementation at a large scale.
Summary
Care of the neonates in hypothermia prevention devices (incubator, phase changing material) seems to be equally effective in
maintaining temperature of a neonate versus KMC. Outcomes like mortality and hospital stay have not been studied in this
context. Such care often confers additional requirements and cost related to manpower, technical expertise, costly devices, and
lack of continuity of care during transition of low birth weight neonates to home based care.
With no additional costs incurred, KMC, on the other hand, would promote equity of care and facilitate smooth transition of
care from hospital to home.
Research evidence
In an RCT by Kadam et al, 79% of mothers felt comfortable during the KMC and 73% felt they would be able to give KMC at
home.[278]
Summary
KMC seems to be widely acceptable across variable geographical regions and socio-economic backgrounds.
Research evidence
Many studies have evaluated the feasibility of implementation of KMC and have highlighted the fact that
KMC is feasible. [278] [279]
79 of 103
Summary
No major concerns seem to emerge with widespread implementation of KMC.
Rationale
The evidence for the efficacy of KMC compared to other hypothermia prevention methods is sparse and emerges from only two
studies. However, despite very low CoE, the recommendation is graded as ‘strong’ due to abundant literature on the overall
benefits of KMC compared to conventional care in terms of short-term and long-term outcomes. Further, there are no major
concerns with cost and resource implications for its widespread implementation.
Population: stable neonates (1b)

Intervention: Kangaroo mother care
Comparator: Hypothermia prevention strategies (other than KMC)
Certainty of
Summary
Timeframe measurements Non KMC KMC (Quality of
evidence)
17 27 Very low
Due to serious risk
Relative risk 1.57 per 100 per 100 of bias, Due to
Hyperthermia
1 (CI 95% 1.15 — 2.14)
serious
Based on data from 13 Difference: 10 more per 100 Kmc worsens
2 indirectness, Due
participants in 1 studies. ( CI 95% 3 more — hyperthermia
6 Important to serious
(Observational (non- 19 more ) imprecision, Due
randomized)) to very serious
3
imprecision
Relative risk 0.08 20 2 Very low

Hypothermia
4 (CI 95% 0.03 — 0.2)
Based on data from 13 Kmc may improve
5 of bias, Due to
participants in 1 studies. Difference: 18 fewer per 100 hypothermia
6 Important serious
(Observational (non- ( CI 95% 19 fewer 6
imprecision,
randomized)) — 16 fewer )
55 55 Very low
Due to very
per 1000 per 1000 serious risk of bias,
Neonatal Relative risk 1 serious
(CI 95% 1 — 1) Difference: 0 fewer per 1000 inconsistency, We are uncertain whether
mortality
Based on data from 29 ( CI 95% 0 fewer serious kmc improves or worsen
7 — 0 fewer ) indirectness, neonatal mortality
9 Critical serious
imprecision, and
very serious
8
imprecision
80 of 103
Certainty of
Summary
Timeframe measurements Non KMC KMC (Quality of
evidence)
Neonatal sepsis
0 0
per 1000 per 1000
(0 — 0) that looked at neonatal
6 Important Difference: 0 fewer per 1000 sepsis
0 fewer — 0 fewer
Re- 0 0
hospitalisation Relative risk 0 No studies were found
per 1000 per 1000
(0 —) that looked at re-
Difference: 0 fewer per 1000 hospitalisation
6 Important
0 fewer — 0 fewer
Exclusive
breastfeeding at
0 0 No studies were found
0 per 1000 per 1000
discharge that looked at exclusive
(0 — 0)
breastfeeding at
Difference: 0 fewer per 1000 discharge
6 Important 0 fewer — 0 fewer
Measured by:Temperature
36.69 36.9 Very low
Due to very
(Mean) (Mean) We are uncertain whether
Abdominal monitor serious risk of bias,
kmc improves or worsen
temperature Scale: 36.5 — 38 High Due to serious
Difference: MD 0.23 higher abdominal temperature,
better indirectness, Due
CI 95% when compared to
Based on data from 29 to serious
3 Not Important 9 incubator care for
participants in 1 studies. imprecision, Due
neonates 770 to 2710 g.
(Randomized controlled) to very serious
10
imprecision
Duration of
hospital stay No studies were found
Lower better that looked at duration of
hospital stay
5 Important
1. Temperature 38 degree or higher

3. Risk of Bias: serious. Cross over non randomised design. Inconsistency: no serious. Indirectness: no
serious. Imprecision: very serious. Only data from one study, Low number of patients. Publication bias: no
serious.
4. Temperature < 36.5 degree C
6. Risk of Bias: serious. Cross over non randomised design with alternate 3-hour sessions of each
intervention. Inconsistency: no serious. Indirectness: no serious. Imprecision: serious. Only data from one
study, Low number of patients. Publication bias: no serious.
7. Primary study[275]. Baseline/comparator: Control arm of reference used for intervention. Added from
Relationship between low birth weight and infant mortality: evidence from National Family Health Survey
2019-21, India. Jana et al (for baseline death risk for LBW).
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8. Risk of Bias: very serious. Inadequate/lack of blinding of participants and personnel, resulting in
potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for
detection bias, Inadequate sequence generation/ generation of comparable groups, resulting in potential for
selection bias. Inconsistency: no serious. Indirectness: serious. Direct comparisons not available.
Imprecision: very serious. Low number of patients, Only data from one study. Publication bias: no serious.
resulting in potential for selection bias, Inadequate concealment of allocation during randomization process,
potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for
detection bias. Inconsistency: no serious. Indirectness: serious. Mean temperature reported as s surrogate
of hypothermia and hyperthermia episodes. The true proportions not reported.. Imprecision: very serious.
Only data from one study, Low number of patients. Publication bias: no serious.
82 of 103
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NNF CPG guidelines: Care of Normal Newbon

Technical Report · November 2023

Akash Sharma Anu Thukral

SEE PROFILE SEE PROFILE

Deepika Kainth Vishal Vishnu Tewari

The user has requested enhancement of the downloaded file.

©National Neonatology Forum of India 2023

National Neonatology Forum of India

President: Dr. Siddharth Ramji

President: Dr. Praveen Kumar

Summary of recommendations ................................................................................................................................................................................................................ 5

3. Scope of the guidelines ........................................................................................................................................................................................................................ 10

support by healthcare staff providing routine medical care? .................................................................................................................................................... 16

or side or changing positions)? ............................................................................................................................................................................................................ 70

or b) the use of other hypothermia prevention measures/devices? ...................................................................................................................................... 78

3. Scope of the guidelines

5. Among healthy neonates roomed in with the mother, is lactation support by a

7. Among healthy neonates weighing >1800 g, is daily oral vitamin D supplementation

9. Among healthy neonates, is chlorhexidine or any other antiseptic application on the

Strong recommendation , Moderate certainty evidence

The umbilical cord should be kept clean and dry.

Healthy neonates should be placed in a supine position during sleep.

Weak recommendation against , Very low certainty evidence

Guideline Development Group (alphabetical order)

Editors (alphabetical order)

Dr. Sindhu Sivanandan, Senior Consultant Neonatologist, Kauvery Hospital, Chennai

Dr. Viraraghavan Vadakkencherry Ramaswamy, Consultant Neonatologist, Ankura Hospital, Hyderabad

3. Scope of the guidelines

How to use these guidelines

Figure 1: Steps in formulation of Clinical Practice Guidelines

Questions relevant to clinical practice

A. Questions related to care during birth hospitalization

B. Questions related to care at home

Data abstraction and summary tables of individual studies

Grading the quality of evidence

Generation of evidence profiles

Evidence to Decision (EtD) Framework

The questions included:

• Is the problem a priority?

• Strong recommendation for or against the intervention

the harms in some situations but not in others.

5. Among healthy neonates roomed in with the mother, is lactation support by a

Strong recommendation , Moderate certainty evidence

Benefits and harms Substantial net benefits of the recommended alternative

Certainty of the Evidence Moderate

Values and preferences Substantial variability is expected or uncertain

Resources No important issues with the recommended alternative

Equity No important issues with the recommended alternative

Acceptability No important issues with the recommended alternative

Feasibility No important issues with the recommended alternative

Clinical question/ PICO

Population: Term healthy neonates

Relative risk 0.88

Difference: 37 fewer per

Stopping any Relative risk 0.87 462 402

Stopping any Relative risk 0.93 600 558

Stopping 891 846

Relative risk 0.9

6 months Difference: 85 fewer per

Weak recommendation , Low certainty evidence

Certainty of the Evidence Low

Values and preferences No substantial variability expected

Resources Important issues, or potential issues not investigated