Year: 2010
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.)
Source: New England Journal of Medicine
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: MULTICENTER NETWORK OF NEONATAL INTENSIVE CARE UNITS, General Clinical Research Center, University of New Mexico Clinical and Translational Science Center, Atlanta Clinical and Translational Science Institute (UL1), General Clinical Research Center, NICHD Cooperative Multicenter Neonatal Research Network, General Clinical Research Center, GENERAL CLINICAL RESEARCH CENTER, GENERAL CLINICAL RESEARCH CENTER, GENERAL CLINICAL RESEARCH CENTER, General Clinical Research Center, GENERAL CLINICAL RESEARCH CENTER, Multicenter Network of Neonatal Intensive Care Units, General Clinical Research Center, Stanford Center for Clinical and Translational Education and Research (SCCTER)UL1, NICHD Cooperative Multicenter Neonatal Research Network, UNM HSC Clinical and Translational Science Center, Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network, GENERAL CLINICAL RESEARCH CENTER, NICHD Cooperative Multicenter Neonatal Research Network, Cooperative Multicenter Neonatal Research Network, NICHD Cooperative Multicenter Neonatal Research Network, Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network, Multicenter Network of Neonatal Intensive Care Units, General Clinical Research Center, Cooperative Multicenter Neonatal Research Network - UAB, NICHD Cooperative Multicenter Neonatal Research Network, General Clinical Research Center, Multicenter Network of Neonatal Intensive Care Units, University of Iowa Clinical and Translational Science Program (UL1), General Clinical Research Center, Neonatal Research Network Data Coordinating Center (DCC), Atlanta Clinical and Translational Science Institute (ACTSI) Renewal, Cooperative Multicenter Network of Neontal Intensive Care Units, GENERAL CLINICAL RESEARCH CENTER, University of New Mexico - General Clinical Research Center, NICHD Cooperative Multicenter Neonatal Research Network, General Clinical Research Center, NICHD Cooperative Multicenter Neonatal Research Network - Utah Center, NICHD Cooperative Multicenter Neonatal Research Network, General Clinical Research Center, Yale University Clinical and Translational Science Award Program, MULTICENTER NETWORK OF NEONATAL INTENSIVE CARE UNITS, Data Ctr for the Cooperative Neonatal Research Network, Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network, NICHD Coooperative Multicenter Neonatal Research Network, NICHD Neonatal Research Network Clinical Center UAB, NICHD Neonatal Research Network - Stanford University, NICHD Neonatal Research Network, Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal ResearchNetwork, NICHD Cooperative Multicenter Neonatal Research Network, North Carolina Clinical Center
OpenAlex ID: W1589536239