Clinical trial NCT06810154: Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants
Official title: Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants: a Stepped-Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Necrotizing Enterocolitis (NEC)
Keywords: Probiotics
Necrotizing enteroclitis
preterm infants
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 2170
Sex: ALL
Minimum age (years): 0
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A Stepped-Wedge Cluster Randomized Trial
Primary purpose: PREVENTION

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.

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 outcomes:
measure: Incidence of necrotizing enterocolitis (NEC
timeFrame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Secondary outcomes:
measure: Survival
timeFrame: From date of randomization until the date of 34 weeks corrected gestational age
measure: Late-onset sepsis
timeFrame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
measure: Growth anthropometrics at 36 weeks corrected gestation
timeFrame: at 36 weeks corrected age or discharge from level III NICU whichever occure first.
measure: Time to achieve full enteral feed
timeFrame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Other outcomes:
measure: Probiotic sepsis
timeFrame: birth to discharge from level III NICU or 34 weeks corrected age whichever comes first
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Children's and Women's health of Britch Columbia
state: British Columbia
city: Halifax
country: Canada
facility: IWK
Study officials:
References: