Prospective Meta-Analysis of Oxygen Saturation Trials in Preterm Infants

描述(申请人提供)：早产儿经常需要补充氧气才能存活，但很难确定准确的氧饱和度水平，从而在没有不良影响的情况下优化预后。NICHD/NHLBI资助的支持试验旨在测试在推荐范围内使用血氧饱和度目标进行氧气补充的效果。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 Canada)使用相同的干预措施作为计划的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(NEOProM)，以承担新生儿医学中第一个预期的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都进行了合作，因此结果可以与单个参与者的数据荟萃分析相结合。其中一些试验表明，在推荐的早产儿氧饱和度水平内，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氧饱和度目标而异。对数据进行个体参与者荟萃分析是必要的，因为联合试验的样本量对于检测幸存者的死亡或残疾等重要结果是必要的，因为单独试验报告的点估计和可信区间存在差异。这种个体参与者数据荟萃分析的前瞻性设计是创新的，将是医学界的首创之一。前瞻性荟萃分析克服了回溯性荟萃分析固有的重要局限性。将评估的主要结果是18-24个月大时死亡或严重残疾的综合结果，经出生时妊娠校正。预计这项预期的个体参与者荟萃分析将提供强有力和明确的结果，推动这一领域的发展，让专家和临床医生就建议达成共识，并改善这一高危人群的主要结果。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，可通过应用拟议的分析结果来减少。

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.