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

Imperial College London

Status: Invitation-only

Conditions: Enterocolitis, Necrotizing

Treatments: Dietary Supplement: Probiotics

Study type: Observational

Funder types: Other

Identifiers

NCT06422988

IRAS323099

Details and patient eligibility

About

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).

Enrollment: 48,000 estimated patients

Sex: All

Ages: Under 32 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

48,000 participants in 2 patient groups

Exposed to probiotics

Description:

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.

Treatment:

Dietary Supplement: Probiotics

No probiotic exposure

Description:

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

Treatment:

Dietary Supplement: Probiotics