Neonatal Medicine, School of Public Health, Chelsea and Westminster campus, Imperial College London, London, UK
Neonatal Medicine, School of Public Health, Chelsea and Westminster campus, Imperial College London, London, UK.
BMJ Open. 2019 Sep 20;9(9):e033543. doi: 10.1136/bmjopen-2019-033543.
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.
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 <30+0 gestational weeks+days. Primary feasibility outcomes will be rate of recruitment, opt-out, retention, compliance, data completeness and data accuracy; clinical outcomes will include mortality and NEC. The trial will recruit in two neonatal networks in England for 9 months. Data collection will continue until all infants have reached 40+0 corrected gestational weeks or neonatal discharge. Participant identification and recruitment, randomisation and all trial data collection will be embedded within existing neonatal EPR systems (BadgerNet and BadgerEPR); outcome data will be extracted from routinely recorded data held in the National Neonatal Research Database.
This study holds Research Ethics Committee approval to use an opt-out approach to consent. Results will inform future EPR-embedded and data-enabled trials and will be disseminated through conferences, publications and parent-centred information.
ISRCTN registry ISRCTN62501859; Pre-results.
坏死性小肠结肠炎（NEC）是一种潜在的毁灭性新生儿疾病。输血与 NEC 之间存在时间相关性，这一点已得到充分证实。观察性数据表明，在输血期间暂停肠内喂养可能会降低 NEC 的风险，但这一点尚未在随机试验中得到验证；目前英国的实践做法存在差异。预防 NEC 是一个研究重点，但没有适当规模的试验解决这个问题。简化的默认同意模式的使用以及将试验流程嵌入现有的电子病历（EPR）系统中，为提高试验效率和招募提供了机会。
我们将开展一项随机、对照、多中心、非盲、试点试验，比较两种护理路径：继续喂养牛奶（在输血前、输血期间和输血后）和暂停喂养牛奶（在输血前、输血期间和输血后 4 小时内），婴儿将以相等的概率随机分配。我们将使用默认同意。一项嵌套的定性研究将探讨父母和医疗保健专业人员的观点。如果婴儿出生时胎龄为<30+0 周+天，就有资格参加试验。主要可行性结局将包括招募率、默认同意、保留率、依从性、数据完整性和数据准确性；临床结局将包括死亡率和 NEC。该试验将在英格兰的两个新生儿网络中进行，为期 9 个月。数据收集将持续到所有婴儿达到 40+0 校正胎龄或新生儿出院。参与者识别和招募、随机化和所有试验数据收集将嵌入现有的新生儿 EPR 系统（BadgerNet 和 BadgerEPR）中；结局数据将从国家新生儿研究数据库中记录的常规数据中提取。
本研究获得了使用默认同意方法的伦理委员会批准。研究结果将为未来基于 EPR 的嵌入式和数据驱动的试验提供信息，并将通过会议、出版物和以父母为中心的信息进行传播。
ISRCTN 注册表 ISRCTN62501859；预结果。
