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

NCT06422988 | Enrolling By Invitation

• 1 other identifier: IRAS323099
• Study Type: observational
• Target: 48,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Probiotics

Outcome Measures

Primary Outcomes (1)

• Severe necrotising enterocolitis (NEC)

  NEC confirmed at surgery or postmortem or listed as a cause of death

  From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

Secondary Outcomes (15)

• Necrotising enterocolitis (NNAP definition)

  From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

• Pragmatically defined NEC

  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 to discharge home

  On date of discharge from final neonatal unit, assessed up to 24 months

Study Arms (2)

Exposed to probiotics

Receipt of any probiotic in the first 14 days of life. Probiotics to include: Labinic, Proprems probiotic, Acidophillus, Bifidobacterium, Bio-kult, Infloran, LB2. To address potential recording error, infants whose NNRD records show minimal (one day) of probiotic exposure will only be classed as exposed if they are cared for in a probiotic unit. Probiotic units are defined as: * units who have confirmed that a guideline was in place to provide probiotics to infants born before 32 weeks gestation and that the guideline was in place at any point in the year that the infant was born OR * units where more than 50% of the infants eligible to be part of the cohort received probiotics in the six months after the infant was born.

Dietary Supplement: Probiotics

No probiotic exposure

Did not receive any probiotic in the first 14 days of life.

Dietary Supplement: Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

Any exposure to probiotics in first 14 days of life

Also known as: Labinic, Proprems, Acidophillus, Bifidobacterium, Bio-kult, Infloran, LB2

Exposed to probiotics; No probiotic exposure

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants born very preterm i.e. before 32 weeks gestation

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• University of Nottingham: collaborator
• Newcastle University: collaborator
• Queen Mary University of London: collaborator

Study Sites (1)

Imperial College

London, SW10 9NH, United Kingdom

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Senior Lecturer

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 21, 2024
• Study Start: May 30, 2024
• Primary Completion: July 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

GB (1)