The WHEAT pilot trial-WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial
The WHEAT pilot trial-WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial
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DOI：
10.1136/bmjopen-2019-033543
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发表时间：
2019-09-01
期刊：
影响因子：
2.9
通讯作者：
Juszczak, Ed
中科院分区：
文献类型：
--
作者：
Gale, Chris;Modi, Neena;Juszczak, Ed
坏死性小肠结肠炎（NEC）是一种潜在的毁灭性新生儿疾病。红细胞输注和NEC之间的时间关联已得到充分描述。观察数据表明，在红细胞输注前后停止肠内喂养可能会降低NEC的风险，但这尚未在随机试验中得到验证;目前英国的做法各不相同。NEC的预防是研究的重点，但没有适当的动力试验解决了这个问题。使用一个简化的选择退出同意模型和嵌入试验过程中现有的电子病历（EPR）系统提供了机会，以提高试验效率和招聘。方法和分析我们将进行一项随机，对照，多中心，非盲，试点试验比较两种护理途径：连续喂乳（在红细胞输注之前、期间和之后）和停止母乳喂养（红细胞输注前4小时、输注中4小时和输注后4小时），婴儿以等概率随机分配。我们将使用选择退出同意。一项嵌套定性研究将探讨家长和卫生专业人士的意见。出生于以下年龄的婴儿将符合资格：
Introduction Necrotising enterocolitis (NEC) is a potentially devastating neonatal disease. A temporal association between red cell transfusion and NEC is well described. Observational data suggest that withholding enteral feeds around red cell transfusions may reduce the risk of NEC but this has not been tested in randomised trials; current UK practice varies. Prevention of NEC is a research priority but no appropriately powered trials have addressed this question. The use of a simplified opt-out consent model and embedding trial processes within existing electronic patient record (EPR) systems provide opportunities to increase trial efficiency and recruitment.Methods and analysis We will undertake a randomised, controlled, multicentre, unblinded, pilot trial comparing two care pathways: continuing milk feeds (before, during and after red cell transfusions) and withholding milk feeds (for 4 hours before, during and for 4 hours after red cell transfusions), with infants randomly assigned with equal probability. We will use opt-out consent. A nested qualitative study will explore parent and health professional views. Infants will be eligible if born at