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Набор по приглашению NCT06422988

Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis (NEC) In Infants Born Before 32 Weeks Gestation?

— Наблюдательное Enterocolitis, Necrotizing

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Probiotics.
Кому может быть актуально
Состояния в реестре: Enterocolitis, Necrotizing. Базовые параметры: до 32 Weeks · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis (NEC) In Infants Born Before 32 Weeks Gestation? An Observational Study Using Routinely Collected Data.

Обзор

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).

Вмешательства

  • Пищевая добавка Probiotics
    Any exposure to probiotics in first 14 days of life

Первичные конечные точки

  • Severe necrotising enterocolitis (NEC) [Срок оценки: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months]
Вторичные конечные точки (12)
  • Necrotising enterocolitis (NNAP definition) [Срок оценки: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months]
  • Pragmatically defined NEC [Срок оценки: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months]
  • Late onset sepsis [Срок оценки: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months]
  • Pragmatically defined late onset sepsis [Срок оценки: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months]
  • Survival to discharge home [Срок оценки: On date of discharge from final neonatal unit, assessed up to 24 months]
  • Survival without severe NEC or late onset sepsis (LOS) [Срок оценки: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months]
  • Survival without any NEC [Срок оценки: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months]
  • Brain injury [Срок оценки: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months]
  • Treated retinopathy of prematurity [Срок оценки: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months]
  • Stage of retinopathy of prematurity [Срок оценки: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months]
  • Bronchopulmonary dysplasia [Срок оценки: 36 weeks postmenstrual age]
  • Severe bronchopulmonary dysplasia [Срок оценки: 36 weeks postmenstrual age]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • Imperial College — London

Идентификаторы

NCT: NCT06422988 · IRAS323099

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗