Research

JAMA Pediatrics | Original Investigation | CARING FOR THE CRITICALLY ILL PATIENT

Effect of Nasal Continuous Positive Airway Pressure

on Infants With Meconium Aspiration Syndrome
A Randomized Clinical Trial
Aakash Pandita, MD; Srinivas Murki, DM; Tejo Pratap Oleti, DM; Baswaraj Tandur, DNB; Sai Kiran, DNB;
Sachin Narkhede, MD; Amrut Prajapati, MD

Supplemental content
IMPORTANCE Nasal continuous positive airway pressure (NCPAP) as a primary respiratory
therapy in meconium aspiration syndrome (MAS) has not been studied extensively. Nasal
continuous positive airway pressure, when applied in newborns with MAS, may resolve
atelectasis by sufficiently expanding partially obstructed small airways and stabilizing the
collapsing terminal airways to enhance oxygen exchange.

OBJECTIVE To compare NCPAP vs standard care in neonates with moderate to severe

respiratory failure due to MAS in reducing the need for invasive ventilation.

DESIGN, SETTINGS, AND PARTICIPANTS This multicenter open-label, parallel-group (1:1 ratio)
randomized clinical trial was conducted from August 5, 2014, to May 26, 2016. Data were
collected from 3 tertiary care neonatal intensive care units. All infants admitted with
respiratory distress, defined as Downe score greater than 4 and peripheral capillary oxygen
saturation less than 90%, were assessed for study eligibility if the chest radiograph was
suggestive of MAS and they met the other inclusion criteria: gestation longer than 35 weeks, a
birth weight greater than 2000 g, and born through meconium-stained amniotic fluid.

INTERVENTIONS Infants were randomly assigned to either NCPAP or standard care

(5-10 L/min hood oxygen).

MAIN OUTCOMES AND MEASURES The primary outcome was the need for mechanical
ventilation in the first 7 days of life.

RESULTS After excluding 14 infants, 67 infants were randomized to bubble NCPAP and 68
infants to standard care. Baseline characteristics were similar between the 2 groups. Infants
randomized to the bubble NCPAP group needed mechanical ventilation less frequently in the
first 7 days of life compared with standard care (2 [3.0%] vs 17 [25.0%]); odds ratio, 0.09;
95% CI, 0.02-0.43; P = .002). The need for surfactant (3 [4.5%] vs 11 [16.2%]; odds ratio,
0.24; 95% CI, 0.05-0.87) and culture-positive sepsis (4 [6.0%] vs 13 [19.0%]; odds ratio,
0.28; 95% CI, 0.09-0.93) were higher in the standard care group. There was an increased
duration of oxygen therapy (median [interquartile range], 45.5 [28.0-78.3] vs 26 [20.0-48.0]
hours; P = .001) in the standard care group. In the NCPAP group vs standard care group,
incidence of persistent pulmonary hypertension (9 [13%] vs 19 [28%]; odds ratio, 0.42; 95%
CI, 0.17-1.01) and duration of hospital stay (median [interquartile range], 5.0 [4.0-8.8] vs 4.0
[4.0-6.0] days; P = .14) were similar.

Author Affiliations: Department of

CONCLUSIONS AND RELEVANCE Bubble NCPAP in comparison with standard care for infants
Neonatology, Fernandez Hospital,
with MAS reduces the need for mechanical ventilation in the first 7 days of life. Hyderabad, Telangana, India
(Pandita, Murki, Oleti); Vijay Marie
TRIAL REGISTRATION Clinical Trial Registry, India Identifier: CTRI/2015/03/005631 Hospital, Hyderabad, Telangana,
India (Tandur, Narkhede); Princess
Durru Shehvar Children’s and General
Hospital, Hyderabad, Telangana,
India (Kiran, Prajapati).
Corresponding Author: Srinivas
Murki, DM, Fernandez Hospital,
JAMA Pediatr. doi:10.1001/jamapediatrics.2017.3873 Hyderabad, India
Published online December 4, 2017. (srinivasmurki2001@gmail.com).

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 Research Original Investigation
M
econium staining of amniotic fluid (MSAF) occurs in
10% to 15% of all deliveries. Infants born with MSAF
are 100-fold more likely to develop substantial respi-
ratory distress than infants born through clear amniotic fluid.
About 1.5% to 8.0% of infants born through MSAF develop me-
conium aspiration syndrome (MAS).1,2 Approximately 30% to
50% of infants with MAS have severe MAS, defined as the need
for mechanical ventilation (MV).3-5 The optimum methods of
providing respiratory support to infants with MAS are not
known.6,7 Though ventilation is a life-saving measure, ventila-
tion in itself results in ventilation-induced lung injury, and the
need for MV translates into prolonged hospital stays, in-
creased burden on the health care system, and increased treat-
ment costs.8,9 Nasal continuous positive airway pressure
(NCPAP) as a primary respiratory therapy in MAS has not been
studied extensively. When NCPAP is applied in newborns with
MAS, it may resolve atelectasis by expanding partially ob-
structed small airways and stabilizing the collapsing terminal
airways to enhance oxygen exchange. Nasal continuous posi-
tive airway pressure in MAS may be used as a substitute or as a
bridge to MV. Therefore, we conducted this multicenter ran-
domized clinical trial to evaluate the efficacy of NCPAP in com-
parison with standard care (5-10 L/min hood oxygen ) in reduc-
ing the subsequent need for MV in newborns with MAS.
Methods
Study Design
This open-label, parallel-group (1:1 ratio) randomized clinical
trial was conducted from August 5, 2014, to May 26, 2016, in
India at 3 tertiary care neonatal intensive care units. Each neo-
natal unit has an average of 1200 admissions per year. The study
protocol was approved by the institutional review board from
each of the 3 participating centers and was registered with
clinical trial registry India. Written informed consent was
obtained from the families of eligible infants within an hour
of admission to the neonatal unit.
Study Population
All infants with gestation more than 35 weeks and birth weight
greater than 2000 g admitted to the neonatal intensive care
unit in the first 24 hours of birth were assessed for study eli-
gibility if they were born through MSAF, had respiratory
distress (defined as Downe score >4 and peripheral capillary
oxygen saturation [SpO2] <90% on room air), and if chest ra-
diograph at admission was suggestive of MAS (hyperinflated
lung fields with diffuse nonhomogenous opacity, reticulo-
nodular pattern or low-volume lungs with reticulogranular-
ity, and air bronchograms). All pediatricians and nurses in the
participating hospitals were trained in the use of the Downe
score10 (trial protocol in the Supplement) for assessment of re-
spiratory distress. The exclusion criteria included intubation
at admission, severe asphyxia (5-minute Apgar score <3 and
cord potential of hydrogen level <7.00), pneumothorax and/or
air leak (visible on the admission chest radiograph), and
major malformations. Chest radiograph and arterial blood gas
were performed in all infants prerandomization.
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Effects of NCPAP in Infants With MAS
Key Points
Question Can the use of nasal continuous positive airway pressure
early in the course of meconium aspiration syndrome reduce the
subsequent need for mechanical ventilation in newborns?
Findings In this randomized clinical trial that included 135 infants
with moderate or severe meconium aspiration syndrome, 2 infants
(3%) supported with nasal continuous positive airway pressure
required subsequent mechanical ventilation in the first 7 days of
life vs 17 infants (25%) who were supported with hood oxygen, a
significant difference.
Meaning There is a possibility for reduction in the need for
subsequent mechanical ventilation if infants with moderate or
severe meconium aspiration syndrome are initially supported with
nasal continuous positive airway pressure in place of hood oxygen.
Randomization and Masking
Eligible neonates were randomized (stratified for center) to
either bubble NCPAP or standard care, using a 1 to 1 ratio in ran-
domly permuted blocks of 2 or 4. Random numbers were gen-
erated using a web-based computer program (https://www
.randomizer.org/). Individual group assignments were placed
in a serially numbered opaque sealed envelope that was opened
only after obtaining consent from the parents. The statistician
analyzing outcomes was masked to the group allocation.
Procedures
Infants randomized to the NCPAP group were started on the
bubble NCPAP generator (Fisher and Paykel Healthcare, Inc)
using short binasal prongs (Hudson Respiratory Care, Inc or
Fisher and Paykel Healthcare, Inc). The starting NCPAP was
5 cm of water. Nasal continuous positive airway pressure and
fraction of inspired oxygen (FiO2) were adjusted to maintain
target saturations between 90% to 95%. The neonate was
weaned from NCPAP when the SpO2 was consistently greater
than 90%, the FiO2 was less than 0.25, and respiratory dis-
tress was passive (respiratory rate <60 breathes/min, no or mild
retractions, and no grunting). After weaning from NCPAP,
oxygen if needed, was administered either with a hood or with
binasal oxygen prongs. Failure of NCPAP was defined as SpO2
levels less than 90% on maximum NCPAP pressure of 6 cm of
water and FiO2 of 1.0. All infants with NCPAP failure were
intubated and placed on MV.
Infants randomized to the standard care group were started
on hood oxygen, administered at 5 to 10 L/min. Infants whose
hood oxygen failed (SpO2 < 90% for more than 15 minutes on
FiO2 of 1.0) were rescued either with NCPAP or MV but at the
discretion of the treating team. Those rescued with NCPAP
qualified for MV if SpO2 levels were less than 90% consis-
tently on a maximum NCPAP of 6 cm of water and FiO2 of 1.0.
After extubation or after weaning from NCPAP, oxygen if
needed was administered either with a hood or with binasal
oxygen prongs.
Apart from specified criteria for MV and irrespective of
allocation group, any infant found to have persistent shock
(inotrope >10 μg/kg/min), partial pressure of carbon dioxide
greater than 60 mm Hg with a potential of hydrogen level less
jamapediatrics.com
 Effects of NCPAP in Infants With MAS Original Investigation Research

than 7.20, or a new-onset pneumothorax with hemodynamic

Table 1. Comparison of Baseline Characteristics
instability was mechanically ventilated.
All enrolled infants were actively assessed for any car- No. (%)
diorespiratory dysfunction using vital signs (heart rate, Standard
Treatment Group NCPAP Group
blood pressure, oxygen saturations, and urine output), Variable (n = 68) (n = 67)
Downe score, and echocardiography. Management of comor- Birth weight, mean (SD), g 2963 (426) 2926 (389)
bid conditions such as pulmonary hypertension, shock, sei- Gestation, mean (SD), wk 38.2 (1.3) 38.1 (1.3)
zures, renal dysfunction, fluid, electrolyte, acid and base Male 40 (59) 43 (64)
imbalances, use of high-frequency oscillation, or sildenafil Cesarean birth/LSCD 54 (79) 55 (82)
were as per the existing unit protocols. Surfactant was given Maternal PIH 3 (4.4) 4 (6)
in infants requiring MV (FiO 2 ≥0.50 for >2 hours) and in IUGR 6 (8.8) 4 (6)
those with low-volume lungs on the chest radiograph Apgar 1 min, median (IQR) 7 (3 to 8) 7 (1 to 8)
(<7 posterior intercostal spaces). All the relevant perinatal Apgar 5 min, median (IQR) 8 (6 to 9) 8 (6 to 9)
data and neonatal data until discharge or death were col- Outborn 10 (15) 7 (10)
lected prospectively in special forms designed for this trial.
ET suction at birth 17 (25) 24 (36)
Diagnosis of pulmonary hypertension was based on clini-
Arterial pH, mean (SD) 7.2 (0.07) 7.2 (0.08)
cal and echocardiographic criteria. Infants diagnosed with pul-
Base excess, mean (SD) −5.8 (3.1) −6.3 (2.8)
monary hypertension were managed with inotropes, respira-
Downe score, median (IQR) 5 (5 to 6) 6 (5 to 6)
tory support (NCPAP or MV), and/or sildenafil. Inhaled nitric
oxide was not used. Shock was defined as presence of clinical Abbreviations: ET, endotracheal; IQR, interquartile range; IUGR, intrauterine
growth restriction; LSCD, lower-segment cesarean delivery; NCPAP, nasal
features and need for dopamine or dobutamine at a dose ex-
continuous positive airway pressure; PIH, pregnancy-induced hypertension.
ceeding 10 μg/kg/min.

Outcomes Figure. Study Patients Flowchart

The primary outcome was the need for MV in the first 7 days
of life. The secondary outcomes were death, pneumothorax, 149 Assessed for eligibility
need for surfactant, pulmonary hypertension, culture-
positive sepsis (onset of sepsis >72 hours of birth), duration of 14 Patients excluded
oxygen, and duration of hospital stay. 9 Severe asphyxia
3 Intubated at birth
2 Failed to give consent
Statistical Analysis
Based on the available evidence, we assumed 30% incidence
of MV in the standard care group,3,4 and for an absolute re- 135 Randomized
duction of 20% using NCPAP (based on a pilot study10), the
sample needed to recruit was 66 infants in each group with an
67 Randomized to NCPAP 68 Randomized to standard care group
α error of .05 and a power of 80%. Comparison between the 67 Received intervention as 68 Received intervention as
study groups for discrete variables was done using logistic randomized randomized

regression adjusting for the center. For continuous variables

(duration of oxygen and hospital stay) where distribution was
skewed, normality was achieved by log transformation. For ob-
taining comparative estimates, linear regression was per-
formed for the log-transformed outcomes to adjust for cen-
ters. The coefficient and its 95% confidence interval was
exponentiated to obtain the percentage reduction in the de-
pendent variable between the 2 groups adjusted for center.
Results
During the study period, 149 infants were assessed for eligi-
bility, and 14 were excluded. Among the exclusions, 9 infants
had severe birth asphyxia, 3 were intubated at birth for poor
respiratory efforts, and parents of 2 infants refused consent.
Sixty-seven infants were randomized to the bubble NCPAP
group and 68 infants to the standard care group. Both the
groups were comparable for all the baseline variables includ-
ing gestation, birth weight, sex, growth restriction, median
Apgar score at 1 and 5 minutes, and maternal characteristics
67 Assessed for outcomes 68 Assessed for outcomes
NCPAP indicates nasal continuous positive airway pressure.
(Table 1). The proportion of infants vigorous at birth was com-
parable between the 2 groups. The mean (SD) postnatal age at
randomization was 1.2 (1.0) hours in both the groups. Arterial
potential of hydrogen, base excess, and severity of respira-
tory distress (median [interquartile range] Downe score 6 [5-7]
vs 5 [5-7]; P = .76) at randomization were similar between the
NCPAP and standard care groups, respectively (Figure).
Primary Outcome
The need for MV in the first 7 days of life was significantly lower
in the infants randomized to the NCPAP group (2 [3%] vs 17
[25%]; odds ratio, 0.09; 95% CI, 0.02-0.43); P = .002). For ev-
ery 5 newborns with MAS started on early NCPAP compared
with hood oxygen, one would avoid ventilation in 1 neonate
(risk difference = 22.0%; number needed to treat = 4.5). In the

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 Research Original Investigation
Table 2. Comparison of Outcomes
Standard Care Group
Variable (n = 68)
Primary outcome, No. (%)
Mechanical ventilation 17 (25)
Secondary outcomes, No. (%)
Surfactant 11 (16.2)
Sepsis 13 (19)
Shock 14 (21)
PPHN requiring treatment 19 (28)
Pneumothorax 0 1 (0.31)
Total oxygen duration, median (IQR), hb 45.5 (28.0-73.8)
Hospital stay, median (IQR), db 5.0 (4.0-8.8)
NCPAP group, 1 infant (at postnatal age of 49 hours) was ven-
tilated for increasing oxygen requirement and the other (at
postnatal age of 7 hours) for pneumothorax. In the standard
treatment group, 2 infants received MV without a prior trial
of NCPAP and 17 infants were placed on NCPAP (15 eventually
required MV) for worsening respiratory failure. A total of 4 pa-
tients among the standard care group further required high-
frequency ventilation for failure of conventional ventilation.
None of the infants in the NCPAP group required high-
frequency ventilation. The indications for ventilation in the
standard care group were increasing oxygen requirement (11
infants) and sepsis with shock (6 infants). Among the infants
whose hood oxygen failed (n = 19), the mean (SD) age of shift-
ing to NCPAP or MV was 4.5 (5.0) hours of birth and for ven-
tilation in the NCPAP group (n = 2) was 7.5 (6.0) hours of birth.
Secondary Outcomes
A total of 1 term infant randomized to standard treatment group
died of massive pulmonary hemorrhage, secondary to severe
sepsis and disseminated intravascular coagulopathy. In the
NCPAP group, 1 infant needed MV for pneumothorax. More
infants randomized to the standard care group needed sur-
factant and had culture-positive sepsis. Duration of oxygen was
significantly higher in the standard care group (Table 2).
Discussion
In this trial, we randomized neonates with MAS to NCPAP or
hood oxygen at admission to neonatal intensive care unit. The
mean (SD) age of starting NCPAP was 1.2 (1.0) hours after birth.
Starting NCPAP early reduced the subsequent need for MV.
Many recent studies report limited use of NCPAP for new-
borns with MAS. In the study on the delivery room manage-
ment of vigorous newborns born with MSAF, among the 62
newborns with MAS, only 6 infants (10%) received NCPAP.11
In a trial on oropharyngeal suction at delivery of the head in
MSAF, Vain et al 12 did not report use of NCPAP for MAS.
Understanding the pathophysiology of MAS, early NCPAP
would improve functional residual capacity leading to better
recruitment of alveoli; prevention of secondary surfactant de-
ficiency; and open airways (avoids atelectasis and air trap-
ping) to prevent subsequent development of hypoxia, acido-
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Effects of NCPAP in Infants With MAS
NCPAP Group
(n = 67) Odds Ratio (95% CI)a
Abbreviations: IQR, interquartile
2 (3) 0.09 (0.02-0.43) range; NA, not applicable;
NCPAP, nasal continuous positive
airway pressure; PPHN, pulmonary
3 (4.5) 0.24 (0.05-0.87) hypertension.
a
4 (6) 0.28 (0.09-0.93) Odds ratios are adjusted for center.
b
7 (10) 0.49 (0.18-1.35) The percentage reductions (95%
CI), based on a linear regression
9 (13) 0.42 (0.17-1.01)
estimate (adjusted for center) for
NA the log transformed outcomes, are
26.0 (20.0-48.0) NA 36 (18 to 50) and 12 (−4 to 24) for
total oxygen duration and hospital
4.0 (4.0-6.0) NA
stay, respectively.
sis, and pulmonary hypertension. All these may have
contributed to the reduced need for MV in the group sup-
ported with early NCPAP. However, one may argue that nearly
75% of newborns with MAS would not require any respira-
tory support apart from oxygen as in the standard care group.
We can only counter this argument by stating that increased
or excess use of NCPAP is acceptable to avoid even a few new-
borns going on to MV especially in resource-limited settings.
The reduced need for MV in the NCPAP group in comparison
with our pilot observation13 may be owing to the very early use
of NCPAP in infants with MAS.
The need for surfactant was higher in the standard group.
Delay in initiation of NCPAP may have resulted in secondary
surfactant deficiency, persistent respiratory distress and/or in-
creased work of breathing, and may be the reason for higher
use of surfactant in this group. Increased need for MV and pro-
longed hospital stay in the standard care group may be the rea-
sons for increased incidence of sepsis. The reported inci-
dence on the use of NCPAP or MV for newborns with MAS varies
from 30% to 50%.3-5 In the trial by Vain et al12 among the 99
infants with MAS, 42 infants (42%) required MV, and in the trial
on vigorous infants with MAS by Wiswell et al,11 the inci-
dence of MV was 39% (24 of 62 infants with MAS). The lesser
need for MV in the standard care group in our trial (25%) may
be explained by exclusion of infants with asphyxia and inclu-
sion of predominently inborn infants (90%). Prespecified pro-
tocols on the use of NCPAP or MV may also have reduced in-
dividual variations among the pediatricians and the institutes.
Reducing the need for MV in newborns with MAS has far-
reaching implications, especially in low- and middle-income
countries. Perinatal asphyxia and MAS are the common rea-
sons for MV in these low- and middle-income countries.14 High
mortality (approximately 40%), high incidence of sepsis, and
nonavailability of quality ventilation services are the major
bottlenecks for the use of MV in developing countries.15,16 When
applied early, NCPAP is a safe option to manage infants with
MAS and to prevent up-transfers to already overburdened level
III and/or tertiary care centers and also reduce cost of care.17
However, dependence on imported NCPAP devices, lack of an
ideal interface, nonavailability of round-the-clock air or oxy-
gen supply, backup ventilation, lack of awareness and exper-
tise among physicians, and inadequately trained nursing staff
are the major challenges.18
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 Effects of NCPAP in Infants With MAS Original Investigation Research

Exclusion of infants with severe perinatal asphyxia and
preponderance of inborn newborns may be reasons for lesser
mortality in our study cohort compared with that reported by
others. Although 1 infant in the NCPAP group had pneumo-
thorax, the overall incidence of pneumothorax in this group
is lower than that reported by others. Vain et al12 reported 6%
(6 of their 99 patients) and Bhat and Rao19 reported 27% inci-
dence of air leaks in their patients with MAS.
Strengths and Limitations
A relatively large sample size, multicenter enrollment,
predominantly inborn infants, and standardized criteria for
respiratory management are the main strengths of this study.
Initiation of NCPAP or MV at the discretion of the managing
clinicians, inability to blind the intervention, and use of short-
term hospital-based outcomes are the main limitations of this
study. The results of this study need to be replicated in other
settings and with studies recruiting outborn infants.
Conclusions
Starting early low-level NCPAP in comparison with hood oxy-
gen in neonates with MAS reduces the subsequent need for MV.
For every 5 newborns with MAS started on NCPAP, 1 newborn
is protected from MV.

ARTICLE INFORMATION
Accepted for Publication: August 30, 2017.
Published Online: December 4, 2017.
doi:10.1001/jamapediatrics.2017.3873
Author Contributions: Drs Pandita and Murki had
full access to all of the data in the study and take
responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Murki, Pandita, Tandur.
Acquisition, analysis, or interpretation of data:
Murki, Pandita, Oleti, Kiran, Narkhede, Prajapati.
Drafting of the manuscript: Murki, Pandita, Oleti,
Prajapati.
Critical revision of the manuscript for important
intellectual content: Murki, Pandita, Oleti, Tandur,
Kiran, Narkhede.
Statistical analysis: Murki, Pandita, Oleti, Kiran,
Prajapati.
Administrative, technical, or material support:
Murki, Pandita, Tandur, Narkhede.
Study supervision: Murki, Oleti, Prajapati.
Conflict of Interest Disclosures: None reported.
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