MedTrace Logo

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

NCT06422988 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 48000

Last updated 2025-05-07

No results posted yet for this study

Summary

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).

Conditions

  • Enterocolitis, Necrotizing

Interventions

DIETARY_SUPPLEMENT

Probiotics

Any exposure to probiotics in first 14 days of life

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER

  • Newcastle University

    collaborator OTHER

  • Queen Mary University of London

    collaborator OTHER

  • Imperial College London

    lead OTHER

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2025-07-30
Completion
2026-12-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06422988 on ClinicalTrials.gov