Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial.
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Vaucher Yvonne E, Peralta-Carcelen Myriam, Finer Neil N, Carlo Waldemar A, Gantz Marie G, Walsh Michele C, Laptook Abbot R, Yoder Bradley A, Faix Roger G, Das Abhik, Schibler Kurt, Rich Wade, Newman Nancy S, Vohr Betty R, Yolton Kimberly, Heyne Roy J, Wilson-Costello Deanne E, Evans Patricia W, Goldstein Ricki F, Acarregui Michael J, Adams-Chapman Ira, Pappas Athina, Hintz Susan R, Poindexter Brenda, Dusick Anna M, McGowan Elisabeth C, Ehrenkranz Richard A, Bodnar Anna, Bauer Charles R, Fuller Janell, O'Shea T Michael, Myers Gary J, Higgins Rosemary D, SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network
Аннотация
METHODS: Using a 2-by-2 factorial design, we randomly assigned infants born between 24 weeks 0 days and 27 weeks 6 days of gestation to early CPAP with a limited ventilation strategy or early surfactant administration and to lower or higher target ranges of oxygen saturation (85 to 89% or 91 to 95%). The primary composite outcome for the longer-term analysis was death before assessment at 18 to 22 months or neurodevelopmental impairment at 18 to 22 months of corrected age.
RESULTS: The primary outcome was determined for 1234 of 1316 enrolled infants (93.8%); 990 of the 1058 surviving infants (93.6%) were evaluated at 18 to 22 months of corrected age. Death or neurodevelopmental impairment occurred in 27.9% of the infants in the CPAP group (173 of 621 infants), versus 29.9% of those in the surfactant group (183 of 613) (relative risk, 0.93; 95% confidence interval [CI], 0.78 to 1.10; P=0.38), and in 30.2% of the infants in the lower-oxygen-saturation group (185 of 612), versus 27.5% of those in the higher-oxygen-saturation group (171 of 622) (relative risk, 1.12; 95% CI, 0.94 to 1.32; P=0.21). Mortality was increased with the lower-oxygen-saturation target (22.1%, vs. 18.2% with the higher-oxygen-saturation target; relative risk, 1.25; 95% CI, 1.00 to 1.55; P=0.046).
CONCLUSIONS: We found no significant differences in the composite outcome of death or neurodevelopmental impairment among extremely premature infants randomly assigned to early CPAP or early surfactant administration and to a lower or higher target range of oxygen saturation. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Heart, Lung, and Blood Institute; SUPPORT ClinicalTrials.gov number, NCT00233324.).