Necrotizing Enterocolitis (NEC)
Conditions
Keywords
Probiotics, Necrotizing enteroclitis, preterm infants
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.
Interventions
BIOLOGICALMulti-strain probiotics
Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed.
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A Stepped-Wedge Cluster Randomized Trial
Eligibility
Sex/Gender
ALL
Age
0 Hours to 72 Hours
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of necrotizing enterocolitis (NEC | From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first | NEC defined in CNN according to modified Bell's criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | From date of randomization until the date of 34 weeks corrected gestational age | — |
| Late-onset sepsis | From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first | Culture proven late onset sepsis |
| Growth anthropometrics at 36 weeks corrected gestation | at 36 weeks corrected age or discharge from level III NICU whichever occure first. | Z scores of weight and head circumference |
| Time to achieve full enteral feed | From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first | Defined by reaching 140 mL/kg/day sustained for three consecutive days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Probiotic sepsis | birth to discharge from level III NICU or 34 weeks corrected age whichever comes first | Culture proven sepsis by one of the probiotics products |
Countries
Canada
Contacts
Primary ContactBelal N Alshaikh, MD, MSc
Outcome results
None listed