NCT06422988

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 48,000 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 32 Weeks
• Healthy volunteers: Not accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics	Any exposure to probiotics in first 14 days of life

Timeline

• Start date: 2024-05-30
• Primary completion: 2025-07-30
• Completion: 2026-12-30
• First posted: 2024-05-21
• Last updated: 2025-05-07

Locations

1 site across 1 country: United Kingdom