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Effects of transfusion thresholds on neurocognitive outcome of extremely low birth weight infants (ETTNO) a blinded randomized controlled multicenter trial

输血阈值对极低出生体重婴儿神经认知结局的影响（ETTNO）一项盲法随机对照多中心试验

基本信息

批准号：
130239308
负责人：
Professor Dr. Axel Franz
金额：
--
依托单位：
Abteilung IV: Neonatologie
依托单位国家：
德国
项目类别：
Clinical Trials
财政年份：
2010
资助国家：
德国
起止时间：
2009-12-31 至 2018-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/130239308?language=en
关键词：
Effects transfusion thresholds neurocognitive outcome

项目摘要

Extremely low birth weight (ELBW) infants uniformly develop anemia of prematurity and frequently require multiple red blood cell transfusions (RBCT) during neonatal intensive care. The criteria currently applied to indicate RBCT in this population are based on expert opinion rather than evidence and conclusive data of long-term effects of RBCT practices do not exist. Both, giving RBCT to improve oxygen carrying capacity and restricting RBCT to avoid RBCT associated risks and costs potentially impair long-term development. The proposed blinded randomized controlled trial was designed and will be powered to compare the effect of restrictive versus liberal red blood cell transfusion guidelines on long-term neurodevelopmental outcome in ELBW infants. ELBW infants will be randomized to receive RBCT according to liberal or restrictive RBCT guidelines, which both reflect current practice in Germany and aim for a clinically relevant difference in mean hemoglobin concentrations. The primary outcome measure is the incidence of death or major neurodevelopmental impairment determined at 24 months of age corrected for prematurity. Key secondary outcomes are the incidences of individual components of the composite primary outcome, the mental and physical developmental index scores of the Bayley Scales of Infant Development (II edition), and growth. Safety analyses will assess the incidences of all major diseases of prematurity. The results of this trial may help to improve the quality of life of these patients and reduce long-term health care costs.

极低出生体重儿（ELBW）均会发生早产儿贫血，在新生儿重症监护期间经常需要多次输注红细胞（RBCT）。目前用于指示该人群中RBCT的标准是基于专家意见而不是证据，并且不存在RBCT实践长期影响的结论性数据。给予RBCT以提高携氧能力和限制RBCT以避免RBCT相关的风险和成本两者都可能损害长期发展。拟定的盲法随机对照试验旨在比较限制性与自由性红细胞输注指南对ELBW婴儿长期神经发育结局的影响。ELBW婴儿将根据自由或限制性RBCT指南随机接受RBCT治疗，这两种指南均反映了德国的现行实践，并旨在获得平均血红蛋白浓度的临床相关差异。主要结局指标是在24个月龄时确定的死亡或主要神经发育障碍的发生率（校正早产）。关键次要结局是复合主要结局的单个组分的发生率、贝利婴儿发育量表（II版）的精神和身体发育指数评分以及生长。安全性分析将评估所有主要早产儿疾病的发生率。这项试验的结果可能有助于改善这些患者的生活质量，并降低长期医疗费用。