|Title||Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial.|
|Publication Type||Journal Article|
|Year of Publication||2012|
|Authors||Vaucher YE, Peralta-Carcelen M, Finer NN, Carlo WA, Gantz MG, Walsh MC, Laptook AR, Yoder BA, Faix RG, Das A, Schibler K, Rich W, Newman NS, Vohr BR, Yolton K, Heyne RJ, Wilson-Costello DE, Evans PW, Goldstein RF, Acarregui MJ, Adams-Chapman I, Pappas A, Hintz SR, Poindexter B, Dusick AM, McGowan EC, Ehrenkranz RA, Bodnar A, Bauer CR, Fuller J, T O'Shea M, Myers GJ, Higgins RD|
|Corporate Authors||SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network|
|Journal||N Engl J Med|
|Date Published||2012 Dec 27|
|Keywords||Bronchopulmonary Dysplasia, Child Development, Continuous Positive Airway Pressure, Developmental Disabilities, Female, Follow-Up Studies, Humans, Infant, Infant Mortality, Infant, Extremely Low Birth Weight, Infant, Extremely Premature, Infant, Newborn, Outcome Assessment, Health Care, Oximetry, Oxygen, Oxygen Inhalation Therapy, Pulmonary Surfactants, Retinopathy of Prematurity, Socioeconomic Factors|
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.).
|Alternate Journal||N Engl J Med|
|PubMed Central ID||PMC4140695|
|Grant List||U10 HD021373 / HD / NICHD NIH HHS / United States |
U10 HD040461 / HD / NICHD NIH HHS / United States
UL1 TR000041 / TR / NCATS NIH HHS / United States
U10 HD053089 / HD / NICHD NIH HHS / United States
UL1 TR001449 / TR / NCATS NIH HHS / United States
UG1 HD053089 / HD / NICHD NIH HHS / United States