Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK
School of Medicine and Clinical Practice, University of Wolverhampton Faculty of Science and Engineering, Wolverhampton, UK.
BMJ Open. 2019 Aug 22;9(8):e029421. doi: 10.1136/bmjopen-2019-029421.
In England, for babies born at 23-26 weeks gestation, care in a neonatal intensive care unit (NICU) as opposed to a local neonatal unit (LNU) improves survival to discharge. This evidence is shaping neonatal health services. In contrast, there is no evidence to guide location of care for the next most vulnerable group (born at 27-31 weeks gestation) whose care is currently spread between 45 NICU and 84 LNU in England. This group represents 12% of preterm births in England and over onr-third of all neonatal unit care days. Compared with those born at 23-26 weeks gestation, they account for four times more admissions and twice as many National Health Service bed days/year.
In this mixed-methods study, our primary objective is to assess, for babies born at 27-31 weeks gestation and admitted to a neonatal unit in England, whether care in an NICU vs an LNU impacts on survival and key morbidities (up to age 1 year), at each gestational age in weeks. Routinely recorded data extracted from real-time, point-of-care patient management systems held in the National Neonatal Research Database, Hospital Episode Statistics and Office for National Statistics, for January 2014 to December 2018, will be analysed. Secondary objectives are to assess (1) whether differences in care provided, rather than a focus on LNU/NICU designation, drives gestation-specific outcomes, (2) where care is most cost-effective and (3) what parents' and clinicians' perspectives are on place of care, and how these could guide clinical decision-making. Our findings will be used to develop recommendations, in collaboration with national bodies, to inform clinical practice, commissioning and policy-making. The project is supported by a parent advisory panel and a study steering committee.
Research ethics approval has been obtained (IRAS 212304). Dissemination will be through publication of findings and development of recommendations for care.
NCT02994849 and ISRCTN74230187.
在英国，对于 23-26 孕周出生的婴儿，在新生儿重症监护病房（NICU）接受治疗而非在当地新生儿病房（LNU）接受治疗，可提高出院存活率。这一证据正在改变新生儿保健服务。相比之下，对于下一个最脆弱的群体（27-31 孕周出生的婴儿），目前还没有证据来指导他们的治疗地点。这些婴儿的护理在英格兰的 45 个 NICU 和 84 个 LNU 之间分布，他们占英国所有早产儿的 12%，占所有新生儿病房护理天数的三分之一以上。与 23-26 孕周出生的婴儿相比，他们的住院次数多四倍，每年国民保健服务床位使用天数多两倍。
在这项混合方法研究中，我们的主要目标是评估在英格兰新生儿病房接受治疗的 27-31 孕周出生的婴儿，在每个孕周，在 NICU 接受治疗与在 LNU 接受治疗是否会影响存活率和主要并发症（至 1 岁）。我们将分析从 2014 年 1 月至 2018 年 12 月实时、实时患者管理系统中提取的常规记录数据，这些数据来自国家新生儿研究数据库、医院入院统计数据和国家统计局。次要目标是评估（1）提供的护理差异，而不是关注 LNU/NICU 的指定，是否会影响特定胎龄的结果，（2）在哪里护理最具成本效益，以及（3）父母和临床医生对护理地点的看法，以及这些看法如何指导临床决策。我们的研究结果将与国家机构合作，用于为临床实践、委托和决策提供信息。该项目得到了一个家长咨询小组和一个研究指导委员会的支持。
已获得研究伦理批准（IRAS 212304）。传播将通过发表研究结果和制定护理建议来进行。
NCT02994849 和 ISRCTN74230187。
