Year: 2010
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: Previous studies have suggested that the incidence of retinopathy is lower in preterm infants with exposure to reduced levels of oxygenation than in those exposed to higher levels of oxygenation. However, it is unclear what range of oxygen saturation is appropriate to minimize retinopathy without increasing adverse outcomes. METHODS: We performed a randomized trial with a 2-by-2 factorial design to compare target ranges of oxygen saturation of 85 to 89% or 91 to 95% among 1316 infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. The primary outcome was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before discharge from the hospital, or both. All infants were also randomly assigned to continuous positive airway pressure or intubation and surfactant. RESULTS: The rates of severe retinopathy or death did not differ significantly between the lower-oxygen-saturation group and the higher-oxygen-saturation group (28.3% and 32.1%, respectively; relative risk with lower oxygen saturation, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P=0.21). Death before discharge occurred more frequently in the lower-oxygen-saturation group (in 19.9% of infants vs. 16.2%; relative risk, 1.27; 95% CI, 1.01 to 1.60; P=0.04), whereas severe retinopathy among survivors occurred less often in this group (8.6% vs. 17.9%; relative risk, 0.52; 95% CI, 0.37 to 0.73; P<0.001). There were no significant differences in the rates of other adverse events. CONCLUSIONS: A lower target range of oxygenation (85 to 89%), as compared with a higher range (91 to 95%), did not significantly decrease the composite outcome of severe retinopathy or death, but it resulted in an increase in mortality and a substantial decrease in severe retinopathy among survivors. The increase in mortality is a major concern, since a lower target range of oxygen saturation is increasingly being advocated to prevent retinopathy of prematurity. (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, Aerosolized PGE1 in Neonatal Pulmonary Hypertension, 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, 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: W2210128369