1

THESIS PROTOCOL

TITLE:
Growth parameters at 12months of corrected age of preterm infants less than 33
weeks of gestation who have started on complementary feeding at 6 months of
chronological age- A prospective observational study

NAME AND DESIGNATION OF THE PERSONS UNDER WHOM THE PROJECT IS CARRIED OUT

GUIDE

NAME & DESIGNATION :

Dr. Radhika S
Associate professor and HOD
Department of neonataology
SAT hospital, GMC Thriuvananthapuram

Signature:
:
CO-GUIDE:
Dr. Aswathy Rahul
Assistant professor
Department of neonatology
SAT hospital, GMC Thiruvananthapuram

Signature:

INVESTIGATOR

NAME & DESIGNATION : Dr. PRAKASH

Senior Resident
Department of Neonatology
Government Medical College
Thiruvananthapuram
SIGNATURE:
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UNDERTAKING

I, Dr.Prakash, Senior resident of department of Neonatology, SATH

Thiruvanathapuram, gives an undertaking that all the care will be given to babies
included in my study titled as “Growth parameters at 12 months of corrected age of
preterm infants of less than 33 weeks of gestation who have been started on
complementary feeding at 6 months of chronological age- A prospective
observational study”. The study has not yet started in the Department of Neonatology,
Medical College, Thiruvananthapuram and I shall not start my thesis work before
getting clearance from Ethical Committee, Government Medical College,
Thiruvananthapuram.

Dr. Prakash
Senior Resident,
Department of Neonatology,
Government Medical College,
Thiruvananthapuram
Mobile-9790209151
Email- prakashduraisamy05@gmail.com
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From
Dr Prakash D
DM resident
Department of neonatology
SAT hospital, GMC Thiruvananthapuram

To
The Chairman
Institutional Research Committee
GMC,Thiruvananthapuram

Respected Sir/Madam
I am submitting my research protocol titled “Growth parameters at 12 months of corrected
age of preterm infants less than 33 weeks of gestation who have been started on
complimentary feeds at 6 months of chronological age” – a prospective observational study
for your approval. Kindly do the needful

Thanking you
Yours faithfully

15/11/22
Thiruvanathapuram Dr Prakash D
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1. Title of the dissertation:

Growth parameters at 12 months of corrected age of preterm infants less than 33

weeks of gestation who have been started on complementary feeding at 6 months of
chronological age- A prospective observational study

2. Introduction:

Survival rates for preterm infants have improved significantly in recent years, and this has
allowed accompanying morbidity such as growth and neurocognitive outcomes to be brought
into focus. The widely accepted goal of neonatal nutritional care is to attempt to replicate
intrauterine growth.

Optimal nutrition in the first 1000 days, from conception to the second year of life, has the
potential to shape individual health status during both childhood and adult life . The
relationship between nutrition in early life and long-term outcome is particularly relevant for
preterm infants, whose intrinsic immaturity makes nutritional management a daily challenge
for the neonatologist.

Despite the fact that scientific interest in long-term effects of preterm infants’ nutrition is
constantly growing, to date very little attention has been paid to complementary feeding (CF),
also known as weaning, which is defined by the World Health Organization as “the process
starting when breast milk alone is no longer sufficient to meet the nutritional requirements of
infants’’ so that ‘‘other foods and liquids are needed, along with breast milk’’. No guidelines
about CF in preterm infants exist, and available literature does not provide strong
recommendations on the management of complimentary feeds in preterm infants, as there is
paucity of data on complimentary feeding in preterm infants needs further studies in future.
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B. Rationale:

 Evidence on the optimal time to initiation of complementary feeding in preterm

infants is scarce.

 Preterm infants have higher energy requirements compared with full-term infants
and it is not known how long in infancy milk feeds alone (breastmilk or formula) are
sufficient to meet their requirements.

 Most complementary foods provide higher calorie density compared with milk
feeds, and can make up for the energy gap between increased requirements of
preterm infants.

 Therefore, an earlier introduction of complementary feeding in preterm infants

than is recommended for full-term infants might help improve their growth.

C. Novelty

As there are only few studies on complimentary feeding practices in preterm infants of Indian
origin and there is no prospective study regarding complimentary feeding in Indian settings,
hence this study

3.Research question(s)

Is earlier initiation of complimentary feeding has the potential to influence postnatal growth
restriction in preterm infants of ≤ 32 weeks of gestation at 12 months of corrected age?

4. Research hypothesis (es):

Earlier initiation of complimentary feeding in preterm infants of ≤ 32weeks of gestation can

improve the growth of preterm infants at 12 months of corrected age
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5: REVIEW OF LITERATURE AND SUMMARY OF RELEVANT STUDIES:

AUTHOR(S) SAMPLE STUDY KEY FINDINGS

AND
SETTING
Marriot et al 68 RCT Infants in the PWS group
2003 showed higher length
scores and length growth
velocity and no difference
in weight and head
circumference (between
PWS and control group)

Gupta et al 403 RCT No difference in

2017 (Indian) weight/length/head
circumference for age in 4
months versus 6 months of
corrected age
Spiegler et al 3580 Observational Average introduction of
2015 study complimentary feeds was
3.5 months, length and
weight of VLBW at 24
months were positively
influenced by early
introduction of CF
Rodriguez et al 36 Observational 41% infants receive CF
2018 pilot study before 4 months of
corrected age has greater
weight gain at 18 to 24
months of corrected age
Baldassarre Observational
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2018 study
Morgan Pooled results Preterm infants weaned
2003 1694 from 5RCT before 12 weeks featured
(<12 weeks vs slow increase in weight,
>12 weeks) length and head
circumference at 12 weeks
to 18 months and at 18
months no significant
difference

6.Aim and objectives:

1. Primary objective(s):
To study the anthropometric parameters (weight for age/length for age/head
circumference for age/ weight/length for age) and to assess the proportion of postnatal
growth failure rate in preterm infants less than 33 weeks of gestation at 12 months of
corrected age who have started complimentary feeds at 6 months of chronological
age.

2. Secondary objective(s):
To study the complications (defined as hospital admissions/visits) occurring due to
complementary feeding

To determine the percentage of preterm infants on exclusive breast feeding till

6 months of chronological age
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7.Methodology:

Study design: Prospective observational study

Study setting: The study will be conducted in the Department of neonatology, follow up
clinic SATH, Thiruvananthapuram (tertiary care centre)

Study Population- All the preterm infants who are born less than 33 weeks of gestation
admitted in both inborn and outborn nursery, who have been started on complimentary feeds
at 6 months of chronological age

Inclusion criteria:
Preterm infants born at < 33 weeks of gestation

Exclusion criteria:
Infants with major malformations/chromosomal/genetic abnormality /≤25 weeks of
gestation and parents not given consent

Study period: 1 year after getting IEC clearance

Sample size:
S= Z2x P x(1-P)/ E2
Z21-α/p - Standard normal variate at 5%type 1 error – 1.96
P- Prevalence of postnatal growth failure in preterm infants – 40 %( Duscik et al)
3.84 X 40 X 60 / 8 X 8= 144 + 10 % attrition

SAMPLING TECHNIQUE:
All consecutive samples satisfying the inclusion criteria will be taken foe study
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STUDY VARIABLES:
1. Baseline demographic data:
Maternal details: Gestational age, blood group, comorbities, infectious serology,
antenatal complications/
Baby details: Birth weight, length, head circumference, sex, period of exclusive breast
feeding, complementary feeding details.
2. Management details: Investigations and treatment

STUDY PROCEDURE:
All preterm infants who are born < 33 weeks of gestation satisfying the inclusion criteria will
be enrolled in this study, baseline anthropometric parameters (weight/length/head
circumference for age) at birth will be recorded and plotted in Fenton’s chart. Babies will be
tracked from birth till discharge, at the time of discharge review date for follow up clinic
corresponding to 3 and 6 months of chronological age will be issued to the parents.

At 6 months of chronological age complimentary feeds will be initiated by principal

investigator after getting written consent from parents, complementary feedings will be
started within 1 week of counselling for initiation of food and breast feeding will be
continued. Handout printed papers about complimentary feeds according to IYCF guidelines
(meal frequency per day, consistency ,texture of food and principles of responsive feeding,
hygiene, feeding during and after illness, maintenance of breast feeding and instructions
about cooking common recipes of the region and utensils size) in local language will be
issued to parents and advised them to maintain a daily dietary record incorporating
information about type, frequency and amount of food consumed by the child and problems
faced during and after feeding. Supplementation of the infants with vitamin D (400IU per
day) and elemental iron (2-3 mg/kg/day) starting from 2 weeks of age will be continued.

Average
Age Texture Frequency amount of Foods
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each meal

6-8 Mashed Daily 2 to 3 2 to 3  Raagi kurukku

months foods or meals along teaspoon - full  Amirtham podi
Thick with breast kurukku
porridges feeding  Ethakka
kurukku
 Njavara
kurukku
 Mashed fruits
(apple/banana/
carrot)

9 – 12 Mashed Daily 3 meals ½ cup/bowl  Mashed fruits

months foods, finely with continued (125ml) (apple/banana/
chopped and breast feeding carrot)
foods that can  Mashed rice
be picked up (ghee can be
by baby added) /Mashed
idli/Mashed
dosa
 Egg yolk
scramble/egg
yolk
 Raagi/amirtham
podi/ethikka
kurukku

1 - 2 year Staple family Daily 3 meals ¾ to 1 cup

foods with continued /bowl (200ml) Staple family foods
breast feeding
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The principal investigator will record the baseline anthropometric parameters

(weight/length/head circumference for age) at birth, at discharge, 3months and 6 months of
chronological age (Fenton’s chart will be used till 40 weeks of post menstrual age and
followed by age-appropriate WHO Multicentric Growth Reference Charts will be used) and
advised them to follow up for every 3 months till 12 months of corrected age (follow up date
will be issued). During follow up anthropometric parameters (weight/length/head
circumference for age), morbidity enquiry (hospital visits/ admission related to feeding e.g.,
diarrhoea/sepsis/lower respiratory tract infection),24hour dietary recall (using nutrient value
of Indian foods) will be recorded.
We measure the compliance to intervention through telephone calls after initiating
complementary feeds.

STUDY FLOW DIAGRAM

Preterm infants of <33 weeks of gestation

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EXCLUSION CRITERIA
Infants with major malformations/ chromosomal
abnormality / genetic abnormality / ≤ 25 weeks of
gestation and parents not given consent

Baseline growth parameters at birth, at discharge, 3 and 6 months of

.
chronological age will be recorded

Complimentary feeding starting at 6 months of

Chronological age

Hospital
STUDY visitsDEFINITIONS:
at every 3 months [4]
after complimentary
feeds till 12 months of corrected age for measuring
anthropometric parameters
Study definitions: [4]

Proportion of growth failure in preterm infants and

exclusive breast feeding till 6 months will be
assessed

MEASUREMENTS :
1. Anthropometry (weight for age, length for age, head circumference,
weight for length based on Fenton’s chart till term followed by WHO
Multicentric Growth Reference Study chart)
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2. Morbidity enquiry about hospital visits/admissions (complications like

diarrhea, vomiting ,allergic reactions etc.,)
3. 24 hour dietary recall (number of food groups offered/ meal frequency,
consistency of complementary feeding and calorie calculation)

 Weight will be measured by using weighing scale (DELTA weighing

scale)
 Length is measured using infantometer (head is positioned in Frankfurt
plane, legs are fully extended, ankles flexed perpendicularly with the feet
flat against the movable foot board)
 Head circumference measured by using non stretchable plastic tape, should
be measured over most prominent part of the occiput and just above the
supra orbital ridge.

Post natal growth failure :

At 12 months of corrected age
Weight <3th centile in WHO MGRS CHART
Length <3rd centile in WHO MGRS CHART
Head circumference <3rd centile in WHO MGRS CHART

STATISTICAL ANALYSIS
Data will be entered in Microsoft excel and analyzed using SPSS(Statistical Package for
Social Sciences)version 27. Quantitative variables will be expressed in terms of mean and
standard deviation or median and interquartile range based on the normality of data
distribution. Qualitative variables will be expressed in terms of proportions. The association
of outcome with different quantitative variables will be done using Unpaired t-test/Mann
Whitney U test. Chi-square test/ Fischer’s exact t-test will be used to determine the
association between qualitative variables.

Reference’s:
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◦ Gupta, S., Sankar, M., Agarwal, R., & Natarajan, C. (2021). Initiation of
complementary feeding before four months of age for prevention of postnatal growth
restriction in preterm infants. Cochrane Database Of Systematic Reviews, 2021(9).
doi: 10.1002/14651858.cd012153.pub2
◦ Embleton, N. and Fewtrell, M., 2022. Complementary feeding in preterm infants.
◦ Liotto, N., Cresi, F., Beghetti, I., Roggero, P., Menis, C., & Corvaglia, L. et al.
(2022). Complementary Feeding in Preterm Infants: A Systematic Review.
◦ Baldassarre, M., Giannì, M., Di Mauro, A., Mosca, F., & Laforgia, N. (2022).
Complementary Feeding in Preterm Infants: Where Do We Stand?.
◦ Dusick, Anna & Poindexter, Brenda & Ehrenkranz, Richard & Lemons, James.
(2003). Growth failure in the preterm infant: Can we catch up?. Seminars in
perinatology. 27. 302-10. 10.1016/S0146-0005(03)00044-2.
◦ Complementary feeding in preterm infants: a position paper by Italian neonatal,
paediatric and paediatric gastroenterology joint societies Ital J Pediatr . 2022 Aug
5;48(1):143.

◦ Fewtrell M;Bronsky J;Campoy C;Domellöf M;Embleton N;Fidler Mis N;Hojsak

I;Hulst JM;Indrio F;Lapillonne A;Molgaard C;, M. (2017) Complementary feeding: A
position paper by the European Society for Paediatric Gastroenterology, Hepatology,
and Nutrition (ESPGHAN) committee on nutritionMa, Journal of pediatric
gastroenterology and nutrition.
◦ Liotto N;Cresi F;Beghetti I;Roggero P;Menis C;Corvaglia L;Mosca F;Aceti A;On
Behalf Of The Study Group On Neonatal Nutrition And Gastroenterology-Italian
Society Of Neonatology None; (no date) Complementary feeding in preterm infants:
A systematic review, Nutrients.

STUDY PROFORMA
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Name:
Sex:
Gestation:
Antenatal comorbities in mother:
Antenatal ultrasound:
Date of birth:
Time of birth;
Type of feeding (breast feeding/formula feeds- GK/bottle feeding)
Admission details (course in hospital stay)

Anthropometry at birth
Anthropometric parameters Values Interpretation
Weight
Length
Head circumference

Anthropometry at 6 months of chronological age:

Follow up date:
Anthropometric parameters Values Interpretation
Weight
Length
Head circumference

Date and time of starting complementary feeds:

Anthropometry on follow up:

Follow up date:
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Corrected age:
Supplements:

Anthropometric parameters Values Interpretation

Weight
Length
Head circumference

Complications due to feeding: YES/NO

If yes (details of complications)-
24hour dietary recall:
Average amount of foods per day:
Frequency per day:
Issues during/post feeding:
Calories (kcal/kg/day):
Proteins (g/kg/day):

Anthropometry on follow up:

Follow up date:
Corrected age:
Supplements:

Anthropometric parameters Values Interpretation

Weight
Length
Head circumference

Complications due to feeding: YES/NO

If yes (details of complications)-
24hour dietary recall:
Average amount of foods per day:
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Frequency per day:

Issues during/post feeding:
Calories (kcal/kg/day):
Proteins (g/kg/day):

Impression at 12 months of corrected age:

CONSENT FORM
The investigator, Dr. PRAKASH has explained to me about his study “Growth parameters
of preterm infants of less than 33 weeks of gestation at 12 months of corrected age who
 18

have started on complimentary feeds started at 6 months of chronological age -

Prospective observational study”.I have been explained to my full satisfaction the nature
and purpose of the study. I confirm that I have understood the study and had the opportunity
to ask questions. I understand that me and my baby participation in the study is voluntary and
that I am free to withdraw at any time, without giving any reason. I understand that my
withdrawal from study will not affect the medical care provided by the hospital. I understand
that I will not have to undergo any extra procedure as part of the study & that there will not
be any additional financial burden on me from this study. I understand that all my personal
data will be kept confidential by the investigators. I give my free and voluntary consent for
detailed examination, investigations and to participate in the above study.

Name of the principal investigator

Dr. PRAKASH
DM Neonatology resident
Department of Neonatology,
Government Medical College,
Thiruvananthapuram – 695011
Ph: 9790209151
Name and address of the patient__________
Phone ______________________________
Signature of parents______________
Name and address of witness_________
Signature_____________

അനുമതി പത്രം
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ABO RH പൊരുത്തക്കേടുകളുള്ള നവജാതശിശുക്കളിൽ ഹൈപ്പർബിലിറൂബിനെമിയയുടെ

പ്രവചകരായി കോർഡ് ബിലിറൂബിൻ ഹീമോഗ്ലോബിൻ,, ആൽബുമിൻ - സാധ്യതാപഠനം” എന്ന

പഠനത്തെ കുറിച്ച് അന്വേഷകനായ ഡോ റോണക് രാജ് എന്നോട് വിശദീകരിച്ചു പഠനത്തിന്റെ

സ്വഭാവവും ലക്ഷ്യവും എന്റെ പൂർണ സംതൃപ്തിക്കായി വിശദീകരിച്ചു. എനിക്ക് പഠനം മനസിലായെന്നും

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കുഞ്ഞിന്റെയും ഈ പഠനത്തിലെ പങ്കാളിത്തം പൂർണമായും സ്വമേധയാ ഉള്ളതാണെന്നും ഒരു

കാരണവും നൽകാതെ എപ്പോൾ വേണമെങ്കിലും പിൻവലിക്കാൻ എനിക്ക് സ്വാതന്ത്ര്യമുണ്ടെന്നും ഞാൻ

മനസിലാക്കുന്നു.

പഠനത്തിൽ നിന്ന് പിന്മാറിയാൽ ആശുപത്രി നൽകുന്ന ചികിത്സയെ ബാധിക്കില്ലെന്ന് ഞാൻ മനസിലാക്കുന്നു. പഠനത്തിന്റെ

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സാമ്പത്തിക ബാധ്യത ഉണ്ടാവില്ലെന്നും ഞാൻ മനസിലാക്കുന്നു. എന്റെ സ്വകാര്യ ടാറ്റയെല്ലാം അന്വേഷകർ രഹസ്യമായി

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പങ്കെടുക്കുന്നതിനും ഞാൻ എന്റെ സ്വമേധയാ ഉള്ളതുമായ പരിപൂർണ സമ്മതം നൽകുന്നു.

പ്രധാന അന്വേഷകന്‍റെ പേര്: രോഗിയുടെ പേരും വിലാസവും

ഡോ. റോണക് രാജ് _______________________________

ഡി.എം.നിയോനാറ്റോളജി റസിഡന്‍റ്
ഫോൺ________________________
നിയോനാറ്റോളജി വകുപ്പ്,

സർക്കാർ മെഡിക്കൽ കോളേജ്, മാതാപിതാക്കളുടെ ഒപ്പ് ________

തിരുവനന്തപുരം - 695011

ഫോൺ: 7070767593 സാക്ഷിയുടെ പേരും വിലാസവും

_______________________________
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