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?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,170
Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed.
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
Incidence of necrotizing enterocolitis (NEC
NEC defined in CNN according to modified Bell's criteria.
Time frame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Survival
Time frame: From date of randomization until the date of 34 weeks corrected gestational age
Late-onset sepsis
Culture proven late onset sepsis
Time frame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Growth anthropometrics at 36 weeks corrected gestation
Z scores of weight and head circumference
Time frame: at 36 weeks corrected age or discharge from level III NICU whichever occure first.
Time to achieve full enteral feed
Defined by reaching 140 mL/kg/day sustained for three consecutive days
Time frame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
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