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临床试验/NCT05934123
NCT05934123已完成不适用

Effects of Implementation of a Care Bundle on Rates of Necrotising Enterocolitis and Own Mother's Milk Feeding in the East Midlands: a Mixed Methods Impact and Process Evaluation Study

University Hospitals of Derby and Burton NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 53,600 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53,600
试验地点
1
主要终点
Severe NEC requiring surgery or resulting in death

研究概览

简要总结

Necrotising enterocolitis (NEC) is a life-threatening gut disease in babies born early. Feeding preterm babies their own mother's milk prevents NEC. Fewer babies in the East Midlands get their own mother's milk than the national average, and more babies get NEC.

The East Midlands Neonatal Operational Delivery Network (EMNODN) has created a care bundle to increase own mothers' milk feeding and reduce rates of NEC among babies born more than 8 weeks early, who are at the greatest risk of NEC. The care bundle describes the support that parents can expect to receive to help mothers feed their breastmilk to their babies. It also provides guidelines to help neonatal units ensure babies receive optimum nutritional care.

This study will find whether this bundle is effective in helping more babies receive their own mothers' milk and in reducing NEC. It will also identify how well the bundle was introduced and which parts of the bundle were most helpful.

The study team will answer these questions by collecting and studying data from babies' medical records.

详细描述

Necrotising enterocolitis (NEC) is a serious, life-threatening disease in preterm infants. Preterm birth, affecting over 52,000 babies per year (around 7.3% of live births), is the largest cause of neonatal mortality in the UK. The 2019 NHS Long Term Plan aims to reduce neonatal mortality by 50% with plans to "improve the safety and effectiveness of neonatal critical care" and "enhance the experiences of families" during this worrying period.

An estimated 12% of infants born weighing <1500g develop NEC and 30% of these die. Survivors have an increased risk of adverse neurodevelopmental outcomes, including cerebral palsy and cognitive impairment. In the UK, NEC rates are collected by the National Neonatal Audit Programme (NNAP), a national audit run by the Royal College of Paediatrics and Child Health, commissioned by the Healthcare Quality Improvement Partnership (https://nnap.rcpch.ac.uk).

The East Midlands Neonatal Operational Delivery Network (EMNODN) (https://www.emnodn.nhs.uk) is one of 11 clinically managed Neonatal Operational Delivery Networks in England. ODNs were formed, in 2003, by the Department of Health, to ensure that babies and their families receive high quality, equitable and accessible care. The rate of NEC in the EMNODN has remained above the national average since 2017 (when this measure was added to NNAP) and there are wide variations between units.

Preterm infants are unable to directly suckle on the breast. Mothers express breastmilk which is fed to their infant via an oro/nasogastric tube. As infants grow and mature, they develop the ability to suck and swallow and establish breastfeeding. Some infants continue to receive own mother's milk via a cup, syringe, or bottle as per parental choice; all these are included within 'own mother's milk feeding'. Encouraging and supporting own mother's milk feeding prevents NEC and has several additional advantages, including improved long-term neurodevelopment and parent-infant bonding. Health economic analysis estimates that if all premature infants were fed own mother's milk, the total lifetime cost saving to the NHS would be £46.7 million (£30.1 million in the first year of life) and there would be 238 fewer deaths per year with a gain of £153.4 million in lifetime productivity. The adjusted incremental costs of medical NEC and surgical NEC over and above the average costs incurred for extremely premature infants without NEC, in 2011, were estimated to be $74,004 (95% confidence interval (CI), $47,051-$100,957) and $198,040 (95% CI, $159,261-$236,819) per infant, respectively.

Early start and continuation of feeding with own mother's milk, such that babies go home breastfeeding, is vital to ensure babies continue to receive own mother's milk throughout neonatal care and remain at a reduced risk of NEC. Unfortunately, in NNAP, rates of any breast milk feeding at discharge in EMNODN have been consistently below the national average, again with wide local variations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • All infants born at <32 weeks' gestational age admitted for neonatal care in England and Wales between 01/01/2016 to 30/09/2023 and who survived at least 48 hours
  • Exclusion criteria:
  • Infants whose data are not included in the National Neonatal Research Database (NNRD)

排除标准

  • 未提供

结局指标

主要结局

Severe NEC requiring surgery or resulting in death

时间窗: Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)

Incidence rate ratio for incidence of severe NEC requiring surgery or resulting in death in evaluation phase compared to pre-implementation phase

Receiving any own mother's milk at discharge

时间窗: Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)

Incidence rate ratio for incidence of receiving any own mother's milk at discharge in evaluation phase compared to pre-implementation phase

Receiving any own mother's milk on day 14 of life

时间窗: Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22)

Incidence rate ratio for incidence of receiving any own mother's milk on day 14 of life in evaluation phase compared to pre-implementation phase

次要结局

  • Any NEC, including NEC not requiring surgery and not resulting in death(Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22))
  • Exclusive own mother's milk feeding at discharge(Evaluation phase (01/23-09/23) compared to pre-implementation phase (01/16-08/22))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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