Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants
NCT ID: NCT06810154
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
2170 participants
INTERVENTIONAL
2025-06-01
2028-05-30
Brief Summary
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* Does the use of a multi-strain probiotic combination reduce the incidence of NEC in preterm infants?
* Are there any adverse effects associated with the administration of this probiotic combination?
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Detailed Description
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Control Phase: No probiotics will be administered, and outcomes will be recorded to establish baseline NEC rates.
Intervention Phase: Participants will receive a daily multi-strain probiotic combination (0.5 g sachet) starting within 24 hours of enteral feeding initiation.
Participants will be:
* Preterm infants born at \<32 weeks' gestation and \<1500 g birth weight.
The study uses a stepped-wedge cluster randomized trial (SW-CRT) design, where neonatal intensive care units (NICUs) transition from the control phase to the intervention phase at pre-specified intervals. Individual consent will be obtained for probiotic administration and data collection during the intervention phase, and data collection-only consent will be sought during the control phase.
This trial is designed to provide high-quality evidence on the efficacy and safety of probiotics in preventing NEC in preterm infants.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Control
Infants will not receive any probiotics.
No interventions assigned to this group
Multi-strain probiotics
Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) within 24 hours of commencing enteral feeds.
Multi-strain probiotics
Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed.
Interventions
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Multi-strain probiotics
Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Conditions affecting gastrointestinal systems that prohibit infants from starting on feed in the first 72 hours after birth.
0 Hours
72 Hours
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Belal Alshaikh
Principle investigator
Locations
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Foothills Medical Center
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Children's and Women's health of Britch Columbia
Vancouver, British Columbia, Canada
IWK
Halifax, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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U of Calgary REB24-1960
Identifier Type: -
Identifier Source: org_study_id
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