Jobe AH, Caplan MS, Oh W, Hensman AM, Gingras D, Barnett S, Lillie S, Francis K, Andrews D, Angela K, Fanaroff AA, Siner BS, Schibler K, Bridges K, Alexander B, Grisby C, Mersmann MW, Mincey HL, Hessling J, Goldberg RN, Auten KJ, Fisher KA, Foy KA, Siaw G, Stoll BJ, Piazza A, Carlton DP, Hale EC, Archer SW, Lemons JA, Hamer F, Herron DE, Miller LC, Wilson LD, Berberich MA, Blaisdell CJ, Gail DB, Kiley JP, Cunningham M, Hastings BK, Irene AR, Auman JO, Huitema CP, Pickett JW 2nd, Wallace D, Zaterka-Baxter KM, Stevenson DK, Ball MB, Proud MS, Fiascone JM, MacKinnon BL, Nylen E, Furey A, Collins MV, Cosby SS, Phillips VA, Rasmussen MR, Wozniak PR, Arnell K, Bridge R, Demetrio C, Widness JA, Klein JM, Johnson KJ, Everett-Thomas R, Ohls RK, Rohr J, Lacy CB, Phelps DL, Reubens LJ, Burnell E, Rosenfeld CR, Salhab WA, Allen J, Guzman A, Hensley G, Lepps MH, Martin M, Miller NA, Solls A, Vasil DM, Wilder K, Morris BH, Tyson JE, Harris BF, Lis AE, Martin S, McDavid GE, Tate PL, Wright SL, Burnett J, Jensen JJ, Osborne KA, Spencer C, Weaver-Lewis K, Peters NJ, Shankaran S, Bara R, Billian E, Johnson M, Ehrenkranz RA, Jacobs HC, Cervone P, Gettner P, Konstantino M, Poulsen J, Taft J, Avery G, Gleason CA, Allen MC, Bangdiwala SI, Blaisdell CJ, Gail DB, Hunt C, Boyle RJ, Clemons T, D'Alton ME, Das A, Poole WK, Keszler M, Redmond CK, Ross MG, Thomson MA, Weiner SJ, Willinger M, Markowitz GD, Hutchinson AK, Wallace DK, Freedman SF.
Abstract
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.)
2010 Massachusetts Medical Society