Preterm infants frequently need oxygen supplementation to survive but it is difficult to determine the precise oxygen saturation levels that optimize outcomes without adverse effects. The NICHD/NHLBI-funded SUPPORT Trial was designed to test the effects of oxygen supplementation using oxygen saturation targets in the recommended range. Four other multicenter randomized controlled trials (BOOST II United Kingdom, BOOST II Australia, BOOST II New Zealand, COT Canada) used the same intervention as SUPPORT as part of a planned prospective analysis. The group formed the Neonatal Oxygenation Prospective Meta-analysis Collaboration (NeOProM) to undertake the first prospective individual participant data meta-analysis in neonatal medicine. The investigators of all the five trials collaborated in the design and data collection so the results could be combined with an individual participant data meta-analysis. Some of these trials indicate that within the levels of oxygen saturations recommended for preterm infants the risks for death, retinopathy of prematurity, bronchopulmonary dysplasia, and necrotizing enterocolitis may differ by oxygen saturation targets. An individual participant meta-analysis of data is essential because the sample size of the combined trials is necessary to detect important outcomes such as death or disability in survivors because the individual trials reported differences in the point estimate and confidence intervals. The prospective design of this individual participant data meta-analysis is innovative and will be one of the first in medicine. The prospective meta- analysis overcomes important limitations inherent to retrospective meta-analysis. The primary outcome that will be assessed is a composite outcome of death or major disability at 18-24 months of age corrected for gestation at birth. It is expected that this prospective individual participant meta-analysis will provide robust and definite results that can drive the field, inform experts and clinicians to develop consensus on recommendations, and improve major outcomes in this high risk population. Preterm infants are an increasingly important public health constituency with high mortality and long-term morbidities that may be reduced by application of the results of the proposed analyses.
Preterm infants often need oxygen supplementation to survive and improve their outcomes but there have been insufficient data on which to determine how much oxygen needs to be administered. The current application is to conduct an analysis of the results of the five randomized controlled trials of oxygen saturation targeting in preterm infants. These trials were prospectively designed to be combined in an innovative analysis that considers individual patient characteristics to provide the highest level of evidence for clinician to care for these infants.