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ClinicalTrials.gov ID

NCT06810154

Lead Sponsor

University of CalgaryOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

2,170Estimated

Last Update Posted

Feb 5, 2025Actual

Start Date

Jun 1, 2025Estimated

Primary Completion Date

May 30, 2027Estimated

Completion Date

May 30, 2028Estimated

Official Title

Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants: a Stepped-Wedge Cluster Randomized Trial

Brief Summary

The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) in preterm infants born at less than 32 weeks of gestation. The main questions it aims to answer are:

• 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?

Detailed Description

Researchers will compare outcomes between two phases:

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.

• Necrotizing Enterocolitis (NEC)

• Multi-strain probiotics

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Infants born between <32 0/7 weeks gestation.

Exclusion Criteria:

• Major congenital or chromosomal abnormalities
• Conditions affecting gastrointestinal systems that prohibit infants from starting on feed in the first 72 hours after birth.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

University of CalgaryOTHER

kumar.kumaran@ahs.ca780-735-5179

balpreet.singh@iwk.nshealth.ca902-470-7055