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Enrolling by invitation NCT06422988

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

— Observational Enterocolitis, Necrotizing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Probiotics.
Who it may be relevant to
Registry conditions: Enterocolitis, Necrotizing. Basic parameters: up to 32 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • Dietary supplement Probiotics
    Any exposure to probiotics in first 14 days of life

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Imperial College — London

Identifiers

NCT: NCT06422988 · IRAS323099

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗