Centre for Perinatal Research, School of Medicine, University of Nottingham, Nottingham, UK.
Lifespan and Population Health, School of Medicine, University of Nottingham, Nottingham, UK.
BMJ Open. 2024 May 30;14(5):e078633. doi: 10.1136/bmjopen-2023-078633.
Prevention of necrotising enterocolitis (NEC) is vital for improving neonatal outcomes. Feeding own mother's milk helps prevent NEC. Rates of own mother's milk feeding in the East Midlands are lower than the national average and the incidence of NEC is higher. The East Midlands Neonatal Operational Delivery Network (EMNODN) has created a care bundle to improve these in babies born at <32 weeks' gestation, the group at the highest risk of NEC. The bundle was introduced in September 2022 and embedded by December 2022. We will evaluate its effectiveness and conduct a process evaluation to understand barriers and facilitators to implementation.
We will conduct a retrospective cohort study (workstream 1) using data from the National Neonatal Research Database (NNRD). We will identify infants receiving any own mother's milk on day 14 and at discharge, and cases of severe NEC. We will aggregate outcomes by birth month and use interrupted time series analysis to estimate an incidence rate ratio for changes after the care bundle was embedded, relative to pre-implementation. We will model data from all other NNRD units and assess whether there are any concurrent changes to exclude confounding due to other events.We will apply the RE-AIM framework (workstream 2), supplemented by the Consolidated Framework for Implementation Research and Framework for Implementation Fidelity, to conduct a mixed methods evaluation in EMNODN units. We will triangulate data from several sources, including questionnaires and semistructured interviews with parents and healthcare professionals, and data from patient records.
The study has approval from the South East Scotland Research Ethics Committee 01 and the Health Research Authority and Health and Care Research Wales (IRAS 323099). Results will be disseminated via scientific journals and conferences, to neonatal service commissioners and through public-facing infographics.
NCT05934123.
预防坏死性小肠结肠炎（NEC）对于改善新生儿结局至关重要。母乳喂养有助于预防 NEC。东米德兰兹地区的母乳喂养率低于全国平均水平，NEC 的发病率更高。东米德兰兹新生儿运营分娩网络（EMNODN）创建了一个护理包，以改善胎龄<32 周的婴儿的这些情况，这些婴儿是 NEC 风险最高的群体。该护理包于 2022 年 9 月推出，并于 2022 年 12 月实施。我们将评估其有效性，并进行过程评估，以了解实施的障碍和促进因素。
我们将使用国家新生儿研究数据库（NNRD）的数据进行回顾性队列研究（工作流程 1）。我们将确定在第 14 天和出院时接受任何母乳喂养的婴儿以及严重 NEC 的病例。我们将按出生月份汇总结果，并使用中断时间序列分析来估计护理包实施后与实施前相比变化的发病率比。我们将对所有其他 NNRD 单位的数据进行建模，并评估是否存在任何并发变化，以排除其他事件导致的混杂。我们将应用 RE-AIM 框架（工作流程 2），并补充实施研究综合框架和实施保真度框架，在 EMNODN 单位进行混合方法评估。我们将从多个来源（包括问卷和父母和医疗保健专业人员的半结构化访谈以及患者记录中的数据）收集数据，并进行三角分析。
该研究已获得东南苏格兰研究伦理委员会 01 和英国健康研究局和威尔士健康和护理研究局（IRAS 323099）的批准。结果将通过科学期刊和会议、向新生儿服务专员以及通过面向公众的信息图进行传播。
NCT05934123。
