Clinical trial NCT06422988: Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis (NEC) In Infants Born Before 32 Weeks Gestation?
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.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Enterocolitis, Necrotizing
Keywords: Probiotics
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Newcastle University
name: Queen Mary University of London
First posted: 2024-05-21
Enrollment: 48000
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born very preterm i.e. before 32 weeks gestation

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).


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

Primary outcomes:
measure: Severe necrotising enterocolitis (NEC)
timeFrame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Secondary outcomes:
measure: Necrotising enterocolitis (NNAP definition)
timeFrame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
measure: Pragmatically defined NEC
timeFrame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
measure: Late onset sepsis
timeFrame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
measure: Pragmatically defined late onset sepsis
timeFrame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
measure: Survival to discharge home
timeFrame: On date of discharge from final neonatal unit, assessed up to 24 months
measure: Survival without severe NEC or late onset sepsis (LOS)
timeFrame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
measure: Survival without any NEC
timeFrame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
measure: Brain injury
timeFrame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
measure: Treated retinopathy of prematurity
timeFrame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
measure: Stage of retinopathy of prematurity
timeFrame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
measure: Bronchopulmonary dysplasia
timeFrame: 36 weeks postmenstrual age
measure: Severe bronchopulmonary dysplasia
timeFrame: 36 weeks postmenstrual age
measure: Length of stay
timeFrame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
measure: Time to full feeds
timeFrame: Before discharge from final neonatal unit
measure: Growth
timeFrame: 36 weeks corrected gestational age
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College
Study officials:
References: