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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Infants will not receive any probiotics. | |
| Multi-strain probiotics | Experimental | Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) within 24 hours of commencing enteral feeds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-strain probiotics | Biological | Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of necrotizing enterocolitis (NEC | NEC defined in CNN according to modified Bell's criteria. | 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 | Description | Time Frame |
|---|---|---|
| Survival | From date of randomization until the date of 34 weeks corrected gestational age | |
| Late-onset sepsis | Culture proven 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Probiotic sepsis | Culture proven sepsis by one of the probiotics products | birth to discharge from level III NICU or 34 weeks corrected age whichever comes first |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Belal N Alshaikh, MD, MSc | Contact | +1 403 956 1588 | balshaik@ucalgary.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Center | Calgary | Alberta | T2Z 2G9 | Canada |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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A Stepped-Wedge Cluster Randomized Trial
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| Growth anthropometrics at 36 weeks corrected gestation | Z scores of weight and head circumference | 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 | From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first |
| Royal Alexandra Hospital | Edmonton | Alberta | Canada |
|
| Children's and Women's health of Britch Columbia | Vancouver | British Columbia | Canada |
|
| IWK | Halifax | Canada |
|
| D007410 |
| Intestinal Diseases |