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Prophylactic Probiotics to Extremely Low Birth Weight Prematures (PROPEL)
Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common problem resulting in prolonged need for intravenous lines and poor nutrition. The aim of the study is to evaluate whether supplementation with the probiotic bacterium Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight increases feeding tolerance to breast milk and thereby improves nutrition, increases growth and reduces serious complications and mortality in this population. Beyond this, possible mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.
Details
| Lead sponsor | Ostergotland County Council, Sweden |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 134 |
| Start date | 2012-06 |
| Completion | 2015-12 |
Conditions
- Feeding; Difficult, Newborn
- Growth Failure
- Necrotizing Enterocolitis
- Sepsis
Interventions
- Lactobacillus reuteri
- Placebo
Primary outcomes
- Time to Establish Full Enteral Feeds — Birth to gestational week 36+0
The age of the infants in days when the infant receive 150 ml/kg/day via enteral feeding for the first time.
Countries
Sweden