Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis (NEC) In Infants Born Before 32 Weeks Gestation? An Observational Study Using Routinely Collected Data.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 48,000
- 试验地点
- 1
- 主要终点
- Severe necrotising enterocolitis (NEC)
研究概览
简要总结
Necrotising enterocolitis (NEC) is one of the leading causes of mortality and morbidity in very preterm infants. This study aims to determine whether NEC rates are different between infants who receive probiotics versus infants who do not receive probiotics. The study has a retrospective cohort design and will utilise routinely collected data from the UK National Neonatal Research Database (NNRD). The cohort will comprise all infants born before 32 weeks gestation and cared for in neonatal units in England and Wales between 2016 and 2022. A propensity score matched approach will be used to conduct two comparisons: i) the risk of necrotising enterocolitis (NEC) between who do and those who do not receive probiotics in the first 14 days of life ii) the risk of NEC between babies who receive the two most common probiotic products used in UK units, (Labinic and Proprems).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible infants must have been born at less than 32 weeks gestation and be cared for in a English or Welsh unit which contributes data to the National Neonatal Research Database (this includes all NHS neonatal units in England and Wales).
- •Infants born in the period January 1st, 2016, to December 31st, 2022 (7 years) will be included.
排除标准
- •They have missing data for any of: gestational age at birth, birth weight, year of birth and date of death (for those that died).
- •Their NNRD record does not include details of their first admission or begins after Day 3 of life.
- •The absolute value of their recorded birthweight for gestational age z score exceeds 4 or is missing.
- •They die in the first two postnatal days of life.
- •They have a major congenital abnormality
结局指标
主要结局
Severe necrotising enterocolitis (NEC)
时间窗: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
NEC confirmed at surgery or postmortem or listed as a cause of death
次要结局
- Pragmatically defined NEC(From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months)
- Survival without severe NEC or late onset sepsis (LOS)(From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months)
- Treated retinopathy of prematurity(From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months)
- Late onset sepsis(From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months)
- Pragmatically defined late onset sepsis(From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months)
- Survival without any NEC(From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months)
- Necrotising enterocolitis (NNAP definition)(From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months)
- Brain injury(From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months)
- Stage of retinopathy of prematurity(From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months)
- Bronchopulmonary dysplasia(36 weeks postmenstrual age)
- Survival to discharge home(On date of discharge from final neonatal unit, assessed up to 24 months)
- Severe bronchopulmonary dysplasia(36 weeks postmenstrual age)
- Length of stay(From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months)
- Time to full feeds(Before discharge from final neonatal unit)
- Growth(36 weeks corrected gestational age)
研究者
Cheryl Battersby
Clinical Senior Lecturer
Imperial College London