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

Browse trials for

• Enterocolitis, Necrotizing 228

Keywords

• Probiotics

Enterocolitis, Necrotizing

228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.

This study's planned enrollment of 48,000 is above the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.

Lead sponsor

Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Study population

Groups and cohorts

• 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

• Dietary supplementProbiotics

  Any exposure to probiotics in first 14 days of life

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

Primary outcomes

1. Severe necrotising enterocolitis (NEC)

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

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

Secondary outcomes

1. Necrotising enterocolitis (NNAP definition)

   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)).

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

2. Pragmatically defined NEC

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

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

3. Late onset sepsis

   HQIP NNAP case definition

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

4. Pragmatically defined late onset sepsis

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

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

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)

   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

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

7. Survival without any NEC

   NEC is defined as per the NNAP definition

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

8. Brain injury

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

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

9. Treated retinopathy of prematurity

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

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

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

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

    Time frame: 36 weeks postmenstrual age

12. Severe bronchopulmonary dysplasia

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

    Time frame: 36 weeks postmenstrual age

13. Length of stay

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

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

14. Time to full feeds

    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)

    Time frame: Before discharge from final neonatal unit

15. Growth

    Weight for post-menstrual age standard deviation score

    Time frame: 36 weeks corrected gestational age

Study documents

• Protocol and statistical analysis plan ↗ · Apr 23, 2025

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — Study protocol available now. Analysis code will be available after publication of results.