Early CPAP versus surfactant in extremely preterm infants.
BACKGROUND
There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants.


METHODS
We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen).


RESULTS
A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups.


CONCLUSIONS
The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.)
Finer
Neil N
NN
Carlo
Waldemar A
WA
Walsh
Michele C
MC
Rich
Wade
W
Gantz
Marie G
MG
Laptook
Abbot R
AR
Yoder
Bradley A
BA
Faix
Roger G
RG
Das
Abhik
A
Poole
W Kenneth
WK
Donovan
Edward F
EF
Newman
Nancy S
NS
Ambalavanan
Namasivayam
N
Frantz
Ivan D
ID
Buchter
Susie
S
Sánchez
Pablo J
PJ
Kennedy
Kathleen A
KA
Laroia
Nirupama
N
Poindexter
Brenda B
BB
Cotten
C Michael
CM
Van Meurs
Krisa P
KP
Duara
Shahnaz
S
Narendran
Vivek
V
Sood
Beena G
BG
O'Shea
T Michael
TM
Bell
Edward F
EF
Bhandari
Vineet
V
Watterberg
Kristi L
KL
Higgins
Rosemary D
RD
D001034:Apgar Score; D001997:Bronchopulmonary Dysplasia / Q000453:epidemiology*; D045422:Continuous Positive Airway Pressure; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D007226:Infant Mortality; D052577:Infant, Extremely Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D057194:Intention to Treat Analysis; D007442:Intubation, Intratracheal; D008297:Male; D010092:Oximetry; D010100:Oxygen / Q000008:administration & dosage / Q000097:blood; D010102:Oxygen Inhalation Therapy / Q000379:methods*; D011663:Pulmonary Surfactants / Q000627:therapeutic use*; D012178:Retinopathy of Prematurity / Q000453:epidemiology
D011663:Pulmonary Surfactants; D010100:Oxygen
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