Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial.

Abstract

BACKGROUND Previous results from our trial of early treatment with continuous positive airway pressure (CPAP) versus early surfactant treatment in infants showed no significant difference in the outcome of death or bronchopulmonary dysplasia. A lower (vs. higher) target range of oxygen saturation was associated with a lower rate of severe retinopathy but higher mortality. We now report longer-term results from our prespecified hypotheses. 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.).

DOI: 10.1056/NEJMoa1208506

5 Figures and Tables

010020020132014201520162017
Citations per Year

413 Citations

Semantic Scholar estimates that this publication has 413 citations based on the available data.

See our FAQ for additional information.

Cite this paper

@article{Vaucher2012NeurodevelopmentalOI, title={Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial.}, author={Yvonne E. Vaucher and Myriam Peralta-Carcelen and Neil Norman Finer and Waldemar A. Carlo and Marie G. Gantz and Michele C. Walsh and Abbot R. Laptook and Bradley A. Yoder and Roger G. Faix and Abhik Kumar Das and Kurt R . Schibler and Wade Rich and Nancy S. Newman and Betty R. Vohr and Kimberly Yolton and Roy Heyne and Deanne E Wilson-Costello and Patricia W. Evans and Ricki F. Goldstein and Michael J. Acarregui and Ira S. Adams-Chapman and Athina Pappas and Susan R. Hintz and Brenda B. Poindexter and Anna M Dusick and Elisabeth C. McGowan and Richard A. Ehrenkranz and Anna Bodnar and Charles R. Bauer and Janell Fuller and T Michael O'shea and Gary J Myers and Rosemary D. Higgins}, journal={The New England journal of medicine}, year={2012}, volume={367 26}, pages={2495-504} }