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Enrolling by Invitation

NCT Number: NCT06422988

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

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).

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Key information

Conditions

Enterocolitis, Necrotizing Digestive System Diseases Enterocolitis Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College

London, SW10 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

Any exposure to probiotics in first 14 days of life

Other names: Labinic, Proprems, Acidophillus, Bifidobacterium, Bio-kult, Infloran, LB2

Primary outcomes

  1. Severe necrotising enterocolitis (NEC)

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

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

Secondary outcomes

  1. Necrotising enterocolitis (NNAP definition)

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

    NEC diagnosed at postmortem or NEC diagnosed during surgery or NEC diagnosed using clinical and radiographic features (where the infant has at least one clinical feature (bilious gastric aspirate or emesis, abdominal distension, occult, gross blood in stool) and at least one radiographic feature (pneumatosis, hepato-biliary gas, pneumoperitoneum)).

  2. Pragmatically defined NEC

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

    Infants who had a recorded diagnosis of necrotising enterocolitis and received at least 5 consecutive days of antibiotics whilst also nil by mouth

  3. Late onset sepsis

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

    HQIP NNAP case definition

  4. Pragmatically defined late onset sepsis

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

    Growth of any organisms that appear in the NNAP lists of "Clearly pathogenic organisms" and "Other organisms"

  5. Survival to discharge home

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

  6. Survival without severe NEC or late onset sepsis (LOS)

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

    LOS is defined according to the Healthcare Quality Improvement Partnership (HQIP) National Neonatal Audit Programme (NNAP) case definition i.e. blood stream or cerebrospinal fluid confirmed pure growth in culture after first three days of life

  7. Survival without any NEC

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

    NEC is defined as per the NNAP definition

  8. Brain injury

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

    Either left or right grade 3 or higher intra-ventricular haemorrhage or cystic periventricular leukomalacia

  9. Treated retinopathy of prematurity

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

    Defined as cryotherapy, laser therapy or injection of anti-vascular endothelial growth factor therapy for ROP in either or both eyes

  10. Stage of retinopathy of prematurity

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

  11. Bronchopulmonary dysplasia

    Time frame: 36 weeks postmenstrual age

    Defined as any respiratory or ventilatory support or supplemental oxygen at 36 weeks postmenstrual age

  12. Severe bronchopulmonary dysplasia

    Time frame: 36 weeks postmenstrual age

    Defined as ventilation via endotracheal tube or trachestomy, and excluding non-invasive support or CPAP, at 36 weeks postmenstrual age

  13. Length of stay

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

    Number of days between first neonatal unit admission and final neonatal unit discharge for surviving infants

  14. Time to full feeds

    Time frame: Before discharge from final neonatal unit

    Defined as the number of days until an infant is recorded as not requiring any parenteral nutrition or fluid (i.e. no parenteral nutrition or intravenous dextrose)

  15. Growth

    Time frame: 36 weeks corrected gestational age

    Weight for post-menstrual age standard deviation score

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Newcastle University
  • Queen Mary University of London
  • University of Nottingham

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 21, 2024
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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