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Discrepancy in the physical dimensions of nose and continuous positive


airway pressure (CPAP) interface: a possible reason for high rates of nasal
injury in Indian neonates

Article  in  BMJ Innovations · September 2020


DOI: 10.1136/bmjinnov-2019-000372

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MEDICAL DEVICES

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ORIGINAL RESEARCH

Discrepancy in the physical dimensions


of nose and continuous positive airway
pressure (CPAP) interface: a possible
reason for high rates of nasal injury in
Indian neonates
Jagjit Singh Dalal ‍ ‍ ,1,2 Sanketh Kumar Ajmera,3 Kanika Prajapat,3
Tanushree Sahoo,1 Chander Prakash Yadav,4 P V Madhusudhan Rao,3
Alok Thakar,1 Anu Thukral,1 Mari Jeeva Sankar,1 Ashok Kumar Deorari,1
Ramesh Agarwal1

►► Supplemental material is ABSTRACT resulting in possible erosion of columella and


published online only. To view, distension of nostrils.
Background  Properly fitting continuous positive
please visit the journal online
(http://​dx.​doi.o​ rg/​10.​1136/​ airway pressure (CPAP) interface is critical to

Protected by copyright.
bmjinnov-​2019-​000372). the efficacy and safety of nasal CPAP therapy in
1 preterm. Unfortunately, there is a perception that
All India Institute of Medical INTRODUCTION
Sciences, New Delhi, India CPAP interfaces being used in Indian neonatal
2
Pt B D Sharma Post Graduate
Continuous positive airway pressure
intensive care units do not fit well and cause a
Institute of Medical Sciences, (CPAP) provides constant distending
high rate of nasal injury.
Rohtak, Haryana, India pressure to a spontaneously breathing
3
Indian Institute of Technology, Objectives  To determine the nasal
New Delhi, India
preterm neonate for the alleviation of
anthropometric dimensions in preterm (<35
4
National Institute of Malaria mild to moderate respiratory distress due
weeks) Indian neonates and compare them with
Research, New Delhi, India to a variety of diseases. The optimum use
those of commercially available CPAP interfaces.
of CPAP reduces the need for exogenous
Correspondence to Methods  In this cross-­sectional study, relevant
Professor Ramesh Agarwal,
surfactant administration, need for inva-
anterior nasal parameters were measured
All India Institute of Medical sive ventilation and mortality by half in
by three dimensional imaging in 32 preterm
Sciences, New Delhi, India; ​ra.​ preterm neonates.1 Also, it reduces the
aiims@​gmail.​com newborn (26+0–34+6 weeks) and compared
need for upward referral by 50% for
with commercially available 17 short binasal
Received 3 July 2019 advanced respiratory support in neonates
Revised 19 August 2019 CPAP prongs of multiple sizes made by five managed at level-2 facilities.2 Given that
Accepted 12 August 2020 manufacturers. Dimensions for best-­suited CPAP therapy requires much lesser cost
interfaces were generated for Indian neonates. and nursing skills and time than invasive
Results  The mean (SD) gestation and birth ventilation, it has emerged as the major
weight of enrolled neonates were 30.6 (3.0) form of respiratory support modality in
weeks and 1338 (575) g, respectively. The inter low/middle-­ income countries (LMICs).
prong distance was narrower than the upper Accordingly, LMICs have made signifi-
bound of the 95% CI of the columellar width in cant investments for scaling up of CPAP
Hudson type CPAP interfaces in <1250 g weight therapy in their level-2 and level-3 centres
© Author(s) (or their
employer(s)) 2020. No category with discrepancy in measurement in recent years.
commercial re-­use. See rights varying from 0.2 to 0.5 mm and 0.9–1.4 mm at CPAP therapy is based on the simple
and permissions. Published by
BMJ.
midpoint and base of columella, respectively. concept. It involves delivery of heated
Similarly, the lower bound of 95% CI of the and humidified air–oxygen mixture at a
To cite: Dalal JS, Ajmera SK, distance between the lateral walls of the nostrils constant pressure of 3–10 cm of water at
Prajapat K, et al. BMJ
Innov Epub ahead of
was narrower than the width of the prongs by the patient end. The CPAP can be gener-
print: [please include Day 1–3 mm. ated using several machines that vary
Month Year]. doi:10.1136/ Conclusions  There is mismatch between nasal from a proper ventilator to a simple
bmjinnov-2019-000372
prongs and nose dimension of Indian neonates bubble CPAP (online supplemental

  
Dalal JS, et al. BMJ Innov 2020;0:1–7. doi:10.1136/bmjinnov-2019-000372 1
MEDICAL DEVICES

BMJ Innov: first published as 10.1136/bmjinnov-2019-000372 on 16 September 2020. Downloaded from http://innovations.bmj.com/ on September 17, 2020 at India:BMJ-PG Sponsored.
figure 1). The CPAP pressure is delivered to the collaboration with Indian Institute of Technology,
patient using a nasal interface (ie, most commonly Delhi. The study was approved by the institutional
by short binasal prongs) that fit in neonate’s nostrils. ethics committee of AIIMS, New Delhi. In this study,
Despite the simplicity of design and ease of use, the we aimed at comparing nostril dimensions of preterm
CPAP is associated with significant nasal injury in a Indian neonates with the relevant dimensions of the
large proportion of neonates. In developed nations, commonly available CPAP nasal prongs.
the incidence of nasal injury has been reported
Measurement of nostril dimensions
to vary from 20% to 60% with 10%–30% being Participant recruitment
moderate to severe.3–6 The incidence and severity Preterm neonates of 26+0–34+6 weeks of gestation
of this injury is higher in lower gestation neonates were enrolled after written informed consent from
and with prolonged use. The nasal injury is asso- one of the parents. We excluded neonates with major
ciated with significant pain, bleeding, crusting and congenital malformation affecting the nose, cleft of
healthcare-­associated infection and is perceived to lip and palate, dysmorphic facies or suspected genetic
be a major hindrance in its wide-­scale use. syndromes.
The problem of nasal injury with CPAP use is much
worse in Indian (and other LMICs) neonates than Imaging procedure
their Caucasian counterparts in developed nations. We performed photography of the mid-­facial structures
The reported incidence in Indian neonates is 2–3 of enrolled neonates from different directions using a
times higher (60%–80%) with one-­third of them being three-­dimensional (3D) camera with blue light (ATOS
moderate to severe in nature (17%–31%) compared Core 5M Multiple distributors with APM technology,
with their Caucasian counterparts.7–9 The high inci- GOM mbh, Braunschweig, Germany). The procedure
dence of nasal injury in LMICs is likely due to multiple was carried out when the neonates did not require any
factors including low nurse–patient ratio, suboptimal nasal respiratory support. We did not use any sedation
nursing skills, malnutrition of the neonate, humidifica- and carried out the procedure under strict asepsis and
tion issues and the design of the nasal interface. While 1 hour post-­feeding when neonates were calm. It took
the clinicians and policymakers try to address other approximately 30 min for imaging a neonate.

Protected by copyright.
issues, the one related to CPAP interface design has
Analysis of the images
largely remained unaddressed despite being critical to
Some basic assumptions in measurement process for
the pathogenesis of the nasal injury.
our study were: every neonate’s face is symmetrical
The commonly available short binasal prongs in
about a plane that divides the face into an enantio-
Indian markets (Argyle (Covidien Healthcare, USA)
meric pair which has a total 12 df (degree of freedom):
and Hudson type (manufactured by four firms: (a)
six translational and six rotational. By setting two
Phoenix Medical System, India, (b) Hudson Respira-
mutually perpendicular planes passing through the
tory Care, USA, (c) GaleMed, Taiwan and (d) Respi-
line connecting the outer most point of the nose the
care Solutions, Great Group Medical Co, Taiwan))
df can be restricted to 4. Further, one of these two
have been designed using nasal anatomical measure-
planes is set parallel to the philtrum, which constricted
ment of Caucasian neonates.10 There are fundamental
the remaining two rotational df. Finally, these three
differences between the nasal dimensions of Indian
mutually perpendicular planes acted as a coordinated
and Caucasian neonates, for example, the columella
system for all facial measurements (online supple-
(middle septum of the nose) is thicker in former.11
mental figure 2).
Consequently, the space provided between two prongs
The raw images consisted of surface mesh recon-
of these nasal interfaces is lesser for the thickness of
structed from 3D scanning of baby facies. From the
columella causing its impingement and erosion—the
raw digital images, we selected images that depicted
most common type of injury.12–14
complete mesh with clearly identifiable three coordi-
Despite these concerns, there is no systematic inves-
nates of important facial landmarks. The images with
tigation assessing the appropriateness of the design of
incomplete meshes or indistinct coordinates were
commonly available CPAP interfaces with the anatom-
discarded. Using the optimum quality of digital images
ical nostril dimensions of Indian neonates. In this
(online supplemental figures 3–5), we extracted X, Y
study, we systematically measured nostril dimensions
and Z coordinates of the important facial landmarks
of Indian neonates and tried to determine if the design
and measured nasal and other relevant facial dimen-
of the currently available CPAP interfaces is appro-
sions with the help of Rhinoceros V.5.0 software
priate for them.
(Robert McNeel & Associates, North America, Seattle,
USA). All the parameters were measured with the
METHODS AND MATERIAL
precision of 0.01 mm.
This cross-­sectional study was conducted between
June 2015 and December 2015 at the Division of Measurement of anterior nasal parameters
Neonatology, Department of Paediatrics, All India We measured the following structures of the colu-
Institute of Medical Sciences (AIIMS), New Delhi in mella: width at upper, mid and lower point (base)

2 Dalal JS, et al. BMJ Innov 2020;0:1–7. doi:10.1136/bmjinnov-2019-000372


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Protected by copyright.
Figure 1  Various dimensions of nose and CPAP prongs, (A) a: horizontal diameter, b: vertical diameter, c: diameter of major (long)
axis, d: diameter of minor (short) axis, e: cross-­sectional area of nostril, f: circumference of nostril opening, g: nose width, h: nose
height. (B) i: columella width upper point, j: midpoint, k: lower point (base), l: wider lower point, m: distance between lateral walls of
the nostrils at midpoint of columella. (C) columella philtrum angle, (D) width of the prongs (distance between outer wall of the two
prongs) and (E) distance between inner wall of the prongs (inter-­prong distance). CPAP, continuous positive airway pressure.

and at lower wider point (figure 1, online supple- (for weight categories of <700 g, 700–1249 g, 1250–
mental figure 3), height and its angle with philtrum. 1999 g and 2000–3000 g) while Argyle prongs have
The other structures of the nose measured were: three sizes (<1000 g, 1000–1500 g and >1500 g). We
horizontal and vertical diameters, major and minor measured two dimensions of these nasal interfaces:
axes, cross-­sectional area, circumference and rota- ‘width of the prongs’ (distance between outer walls
tion of nostrils (angle between major axis and hori- of the prongs, figure 1D) and ‘inter-­prong distance’
zontal diameter) (online supplemental figure 4) and (distance between two nasal prongs, figure 1E).
angulations of anterior nares and columella (angle Commercially available 17 short binasal CPAP prongs
between philtrum and axis of nostril aperture, angle of multiple sizes made by five manufacturers were
of frustum and angle of columella with lateral ala of measured. The short binasal prong measurements
nostril) (online supplemental figure 5). The defini- were taken using a Vernier Calliper with precision of
tion of each parameter as well as graphical measure- 0.01 mm. We also assessed the physical properties of
ment of each dimension has been provided in online the interfaces namely the degree of softness, transpar-
supplemental table 1. ency and whether the margins were rounded or sharp.

Measurement of dimensions of CPAP interfaces Comparison of dimensions of CPAP interfaces with nasal
Two types of CPAP short binasal prongs are commer- structures’ dimensions
cially available in Indian market: (1) Argyle prongs The following comparisons were done: (1) columella
(Covidien Healthcare, USA) and (2) Hudson type width at the midpoint as well at its base versus inter-­
prongs manufactured by four firms ((a) Phoenix nasal prong distance and (2) the actual distance between
prongs by Phoenix Medical System, India, (b) Hudson lateral walls of two nostrils at the level of midpoint of
prongs by Hudson Respiratory Care, USA, (c) Baby columella versus width of the prongs.
Plus by GaleMed, Taiwan and (d) Respicare prongs
by Respicare Solutions, Great Group Medical Co, Quality control
Taiwan). They are of different sizes meant for different Two independent observers took different measure-
weight categories. Hudson type prongs have four sizes ments and average of the two was finally taken. A third

Dalal JS, et al. BMJ Innov 2020;0:1–7. doi:10.1136/bmjinnov-2019-000372 3


MEDICAL DEVICES

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observer rechecked the measurements if there was a Physical dimensions of nose and other relevant mid-facial
discrepancy between or unreliable measurements (too structures
high or too low). The observers were blinded to the Columella
weight and gestation of neonates. The columella was wider at the ends and narrower
at the middle giving it the shape of an hourglass. The
Sample size width at all points and height of columella progres-
From a previous study by Ghosh et al15 in healthy sively increased with an increase in birth weight
term neonates reported mean width of columella as (online supplemental table 2) and gestation (online
0.25 cm with SD of 0.1, precision of 0.02 and CI of supplemental table 3). However, the magnitude of
90% calculated sample size was 11. But because of difference in dimensions between weight categories of
limited feasibility, we planned to take five neonates <750 g and 750–999 g, and between 1000–1249 g and
in each gestation group (26–27 weeks, 28–29 weeks, 1250–1499 g was not clinically substantial. The colu-
30–31 weeks, 32–33 weeks, 34 weeks gestation group) mella–philtrum angle was higher at lower birth weight
for uniformity of the data and finally enrolled 36 categories compared with that in higher birth weight
neonates. Each neonate was enrolled only once in our categories.
study.
Nostrils
Statistical analysis Nostril dimensions are depicted by birth weight (online
Statistical analysis was carried out using Stata V.11.2 supplemental table 4) and gestation (online supple-
(Stata Corp). Categorical variables between the mental table 5) categories. The nostrils were oval with
groups were compared by χ2 or Fisher Exact Test. an inclination towards upper end of the columella such
Continuous variable was compared by Student’s t-­test that the major axis of nostrils makes an angle of approx-
(if normally distributed) or Wilcoxson rank-­sum test imately 40° with the horizontal axis of the nostrils.
(if skewed). The distance between lateral walls of the nostrils at the
midpoint of columella also increased with increase in
birth weight categories. Angulations of anterior nares
RESULTS
and columella relevant to prong design are provided

Protected by copyright.
Of 37 neonates approached, 36 consented to partici-
as supplementary file (online supplemental table 6).
pate in the study and 32 were successfully imaged. The
We also measured some other parameters relevant to
mean (SD) gestation and birth weight of the neonates
construction of appropriate nasal mask and facemask
were 30.6 (3.0) weeks and 1338 (575) g, respectively
(not included in current manuscript).
(table 1). Nearly half (n=17; 53.1%) were males and
one-­third of them were small for dates (n=11; 34.5%).
Dimensions of CPAP interfaces (short binasal prongs)
The median postnatal age at imaging was 8.0 (IQR versus nostril dimensions
3.0–11.0) days. Inter-prong distance of CPAP interfaces versus columella width at
midpoint and lower point
The inter-­prong distance of CPAP interfaces (short
Table 1  Baseline characteristics of the enrolled neonates binasal prongs) of most of the five manufacturers did
not match that of columella width at midpoint or at
Variable n=32
base of the neonates nose in different birth weight
Gestation (week), mean (SD) 30.6 (3.0) categories—being either less (in <1250 g weight cate-
Birth weight (g), mean (SD) 1338 (575) gory) or more (in higher weight category) (table 2).
Postnatal age* at the time of measurement, days, 8.0 (3.0–11.0) The distance between upper bound of 95% CI of the
median (IQR)
columellar width and inter-­prong distance varied from
Time of measurement, n (%)
0.2 to 0.5 mm and 0.9–1.4 mm at midpoint and base
 <72  hours 9 (12.5) of columella, respectively. Nasal prongs during CPAP
 4–7  days 8 (25.0) remain at midpoint or more commonly at the base of
  8–14 days 11 (34.4) columella, hence lower point (base) dimensions were
 15–30 days 4 (12.5) considered for inter-­prong distance while constructing
Weight for gestation best fitting measurements from our study. Argyle
 Less than 10th centile, n (%) 11 (34.5) prongs had better fit for the inter-­prong distance in
 10th to 90th centile, n (%) 18 (56.2) different weight categories (table 2).
 More than 90th centile, n (%) 3 (9.4)
 Male gender, n (%) 17 (53.3) Distance between lateral walls of the Nostrils versus maximum width of
Mode of delivery, n (%) the prongs
 Caesarean 22 (68.7) The width of the prongs was greater than the distance
 Vaginal 10 (31.3) between lateral wall of nostrils in Argyle prongs in all
*Postnatal age is calculated by taking birth as zero point. The weight categories and it was lower in rest four prongs
postmenstrual age refers to gestation age at birth plus postnatal age. (Phoenix, Hudson, Baby Plus and Respicare) in lower

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Table 2  Comparison of columella width at midpoint and at its base versus inter-­prong distance of commonly available CPAP short
binasal prongs in India
Inter-­prong distance
Columella width at Columella width at its
Hudson type nasal prongs
Birth weight midpoint base
Size categories, g (mean (95% CI)) (mean (95% CI)) Phoenix Baby Plus Hudson Respicare
0 <700 1.99 (1.38 to 2.6) 2.67 (2.11 to 3.27) 2.41 1.97 – 2.17
1 700–1249 2.33 (2.08 to 2.58) 3.22 (2.92 to 3.51) 2.08 2.68 2.91 2.47
2 1250–1999 2.81 (2.48 to 3.14) 3.67 (3.34 to 3.99) 4.20 3.86 4.48 4.62
3 2000–3000 3.09 (2.58 to 3.6) 3.73 (3.23 to 4.24) 5.0 4.26 4.6 –
  Argyle nasal prongs
Extra small <1000 2.01 (1.92 to 2.11) 2.90 (2.64 to 3.15) 3.31
Small 1000–1500 2.65 (2.38 to 2.93) 3.50 (3.20 to 3.78) 3.74
Large >1500 3.01 (2.74 to 3.29) 3.76 (3.45 to 4.10) 4.48
All measurements are in mm.
CI, Confidence interval; CPAP, continuous positive airway pressure.

birth weight group (<700 g and 700–1249 g) sugges- orifice was circular which is also not in co-­inside with
tive of mismatch to the size of nostril (table 3). The oval nostrils.
difference between lower bound of 95% CI of the
distance between lateral wall of nostril and width of DISCUSSION
the prongs varied from 1 to 3 mm. In our study, we measured the nasal dimensions rele-
We also studied the physical properties of available vant to CPAP interfaces in preterm (<35 weeks) Indian
interfaces and found that most of them have sharp neonates using a novel 3D photogrammetry technique
margin, angulations variability is very high and some and compared it with the dimensions of CPAP inter-

Protected by copyright.
have prongs of equal length for all weight group babies faces commercially available. We found mismatch
(Baby Plus prongs, Fisher and Paykel prongs and so on) between dimensions of available CPAP interfaces in
Hudson also had same prong length for lower birth market and actual nose parameters of Indian preterm
weight categories (sizes 0, 1 and 2). neonates. The inter-­prong distance of CPAP devices of
The inter-­prong distance of Argyle and Hudson Hudson type binasal prongs (Phoenix, Hudson, Baby
short binasal prongs had good correlation to mid-­ Plus, Respicare) was lesser as compared with columella
columella width (narrowest part of columella), it width at midpoint of the babies of lower birth weight
was not so with at upper end and lower end (base) categories (<700 g and 700–1249 g), thus resulting in
of columella due to hourglass shape of columella high rate of impingement injury. However inter-­prong
(table 2, online supplemental tables 2 and 3, online distance was good in Argyle prong. Similarly, measured
supplemental figure 3). Angulations of nostril were not distance of lateral walls of two nostrils was wider as
taken in to consideration in the design of most of the compared with the maximum width of the four out
interfaces. The surface area of contact of prongs was of five commercially available prongs in lower weight
less leading to more displacement; the shape of prong category (<700 g and 700–1249 g) resulting higher

Table 3  Comparison of the ‘distance between lateral walls of nostrils’ with ‘maximum width of the prongs’ of commonly available CPAP
short binasal prongs in India
Maximum width of prongs
Distance between lateral walls
Hudson type nasal prongs
Birth weight of nostrils at midpoint of
Size categories, g columella (mean (95% CI)) Phoenix Baby Plus Hudson Respicare
0 <700 10.35 (8.58 to 12.17) 7.27 9.01 – 8.85
1 700–1249 11.77 (10.79 to 12.72) 9.64 10.3 10.81 9.51
2 1250–1999 12.93 (12.12 to 13.74) 12.38 12.82 13.58 12.94
3 2000–3000 14.29 (11.91 to 16.46) 15.1 14.42 15.56
  Argyle nasal prongs
Extra small <1000 10.73 (9.88 to 10.78) 10.81
Small 1000–1500 12.77 (12.01 to 13.53) 13.58
Large >1500 13.56 (12.48 to 14.65) 15.56
All measurements are in mm.
CI, Confidence interval; CPAP, continuous positive airway pressure.

Dalal JS, et al. BMJ Innov 2020;0:1–7. doi:10.1136/bmjinnov-2019-000372 5


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rate of displacement in these neonates. Moreover, it to measure nasal parameters instead of less accu-
is hypothesised that the Argyle and Hudson prongs rate manual measurement in preterm neonates. (2)
significantly widened the nose in larger neonates Measurement of a vast set of nasal parameters that
as maximum prong width was more for nose size in would be needed to design an appropriate nasal inter-
larger weight infants . face for Indian preterm neonates. However, our study
We found that the columellar width in neonates is had few limitations too which include small sample
more compared with that in Caucasian neonates, a size. We did not compare angulations of devices
finding that is consistent with that made by Khandekar with the nasal angulations of preterm babies. Simi-
et al.11 Hence, there is an urgent need for design modi- larly, we did not study the appropriateness of nasal
fication of the CPAP interfaces that is more suitable mask. Hence confirmation of these studies focusing
for Indian infants. Among all parameters (birth weight, on preterm infants with larger sample size is essen-
gestation and postmenstrual age), we found birth tial before manufacturers can proceed for design
weight is best correlated with nasal dimensions. Also, modification.
birth weight is more readily known to clinicians than From current study, it appears Argyle prong has better
the gestation of neonates. Therefore, it makes sense fit for nose of Indian preterm infants out of currently
to design prongs for different weight categories than available short binasal prongs in Indian market. Based
those based on gestation. Our nasal anthropometric on our data, we suggest that there should be three sizes
data can be used to improvise existing interfaces as of binasal prongs: size 1 (for less than 1 kg), size 2 (for
well as designing new prongs that is more suitable for 1–1.5 kg) and size 3 for >1.5 kg babies. The proposed
Indian neonates. best-­suited dimensions for the different sizes are: inter-­
Most CPAP prongs used in developing countries like prong distance of 3.15 mm, 3.78 mm and 4.10 mm and
India have been designed for use in developed coun- maximum prong width of <10.78 mm, <13.53 mm
tries. As a result, these imported prongs do not fit well and <14.65 for sizes 1–3, respectively. For each size,
in the nostrils of Indian neonates.16 17 An ideal nasal the prong inclinations/angulation inside nose should
prong should not be so big that it distends the nostrils be around 30° and prong outer diameter should be
and nor it is so small to the point that it lets extra around 3.5 mm.

Protected by copyright.
space or leak between the prong and nostrils.18 Disfig-
urement of the size and shape of the nostrils has been
described in multiple studies with use of nasal inter- CONCLUSION
faces and it was most commonly associated with the The currently available CPAP binasal prongs are not
Hudson prongs.12 19 suited to the Indian neonates which is likely to be
Our study measured all necessary parameters for significant contributory factor to the high rates of nasal
designing an appropriate CPAP interface in the preterm injuries seen in these neonates receiving CPAP. Due to
neonate using a device with high precision (3D photo- small size of our study, there is a need to generate data
grammetry) in contrast to previous studies which in a larger cohort of Indian neonates especially those
measured the limited nasal dimensions in healthy term less than 1200 g. As an interim measure, our nasal
or older infants11 15 20–23 using less accurate manual anthropometric data can be used for design modifica-
technique. For example, Zanki et al22 measured the tion of CPAP interfaces for a better fit and reduced
nose length, philtrum and nasal protrusion with the nasal injury.
help of rigid transparent calliper in term and older
infants. Ghosh et al15 measured columella width, phil- Contributors  JSD conceptualised and designed the study,
developed the protocol, recruited the patients, also wrote the
trum and length of nose in normal and low birthweight first draft of the manuscript. PVMR, SKA and JSD performed the
neonates at 37–40 weeks gestations. measurements. SKA, KP, PVMR and JSD analysed the data. TS,
We used 3D photogrammetry technique for JSD, CPY, AlT and AnT contributed to statistical analysis and gave
critical inputs in performing the study, reviewed the manuscript
obtaining measurement of nasal parameters due to for intellectual content. AKD helped in protocol development
following advantages: non-­ invasiveness, fast image and critically reviewed the manuscript. RA conceptualised and
capturing speed, high precision (up to 0.01 mm), good designed the study, developed protocol and reviewed and finalised
the manuscript. He was the guarantor of the manuscript. All the
reproducibility and ability to measure the angles. Also, authors approved the final manuscript as submitted and agree to be
compared with other methods, it does not distort the accountable for all aspects of the work
images from parallax (measurement error secondary to Funding  The authors have not declared a specific grant for this
variations in camera angle relative to the subject). The research from any funding agency in the public, commercial or
accuracy of this technology has been documented on not-­for-­profit sectors.
mannequin heads, on normal adults and on children Competing interests  None declared.
and adults with non-­cleft facial dysmorphology as well Patient consent for publication  Not required.
as in infants.24 25 However its use in preterm neonates Ethics approval  Institutional ethical clearance from All India
has not been reported in literature so far. Institute of Medical sciences, New Delhi, Ethics committee was
obtained before initiation of study. We obtained informed consent
Strengths of the study are: (1) Use of high preci- from either of parents/legally accepted representative before
sion (with precision of 0.01 mm) 3D photogrammetry enrolling study subjects.

6 Dalal JS, et al. BMJ Innov 2020;0:1–7. doi:10.1136/bmjinnov-2019-000372


MEDICAL DEVICES

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