Prospective Meta-Analysis of Oxygen Saturation Trials in Preterm Infants

描述（由申请人提供）：早产儿经常需要补充氧气来生存，但很难确定精确的氧饱和度水平，以优化结果而不产生不良反应。NICHD/ nhlbi资助的SUPPORT试验旨在测试在推荐范围内使用氧饱和度目标的补氧效果。另外四个多中心随机对照试验（BOOST II英国，BOOST II澳大利亚，BOOST II新西兰，COT加拿大）使用与SUPPORT相同的干预措施作为计划前瞻性分析的一部分。该小组成立了新生儿氧合前瞻性荟萃分析协作组织（NeOProM），开展了新生儿医学领域首个前瞻性个体参与者数据荟萃分析。所有五项试验的研究人员在设计和数据收集方面进行了合作，因此结果可以与个体参与者数据荟萃分析相结合。其中一些试验表明，在推荐的早产儿血氧饱和度水平内，死亡、早产儿视网膜病变、支气管肺发育不良和坏死性小肠结肠炎的风险可能因血氧饱和度目标而异。个体参与者数据的荟萃分析是必要的，因为联合试验的样本量对于检测重要的结果（如幸存者的死亡或残疾）是必要的，因为单个试验报告的点估计和置信区间存在差异。这个个体参与者数据荟萃分析的前瞻性设计是创新的，将是医学上的第一个。前瞻性荟萃分析克服了回顾性荟萃分析固有的重要局限性。评估的主要结果是18-24月龄死亡或重大残疾的综合结果，经出生时妊娠校正。预期这项前瞻性个体参与者荟萃分析将提供可靠和明确的结果，可以推动该领域的发展，告知专家和临床医生就建议达成共识，并改善这一高风险人群的主要结局。早产儿是一个日益重要的公共卫生群体，具有高死亡率和长期发病率，可以通过应用拟议的分析结果来降低。

DESCRIPTION (provided by applicant): 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.