Randomized trial comparing 3 approaches to the initial respiratory management of preterm neonates.
OBJECTIVE
We designed a multicenter randomized trial to compare 3 approaches to the initial respiratory management of preterm neonates: prophylactic surfactant followed by a period of mechanical ventilation (prophylactic surfactant [PS]); prophylactic surfactant with rapid extubation to bubble nasal continuous positive airway pressure (intubate-surfactant-extubate [ISX]) or initial management with bubble continuous positive airway pressure and selective surfactant treatment (nCPAP).


METHODS
Neonates born at 26 0/7 to 29 6/7 weeks' gestation were enrolled at participating Vermont Oxford Network centers and randomly assigned to PS, ISX, or nCPAP groups before delivery. Primary outcome was the incidence of death or bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age.


RESULTS
648 infants enrolled at 27 centers. The study was halted before the desired sample size was reached because of declining enrollment. When compared with the PS group, the relative risk of BPD or death was 0.78 (95% confidence interval: 0.59-1.03) for the ISX group and 0.83 (95% confidence interval: 0.64-1.09) for the nCPAP group. There were no statistically significant differences in mortality or other complications of prematurity. In the nCPAP group, 48% were managed without intubation and ventilation, and 54% without surfactant treatment.


CONCLUSIONS
Preterm neonates were initially managed with either nCPAP or PS with rapid extubation to nCPAP had similar clinical outcomes to those treated with PS followed by a period of mechanical ventilation. An approach that uses early nCPAP leads to a reduction in the number of infants who are intubated and given surfactant.
Division of Neonatology, Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada. michael.dunn@sunnybrook.ca
Michael S
MS
Dunn
Joseph
J
Kaempf
Alan
A
de Klerk
Rose
R
de Klerk
Maureen
M
Reilly
Diantha
D
Howard
Karla
K
Ferrelli
Jeanette
J
O'Conor
Roger F
RF
Soll
D016001:Confidence Intervals; D045422:Continuous Positive Airway Pressure / Q000379:methods*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007442:Intubation, Intratracheal / Q000379:methods; D008297:Male; D016017:Odds Ratio; D011247:Pregnancy; D011663:Pulmonary Surfactants / Q000008:administration & dosage*; D012121:Respiration, Artificial / Q000379:methods; D012127:Respiratory Distress Syndrome, Newborn / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
D011663:Pulmonary Surfactants