Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns
Symbiotic interaction between probiotics ("Living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium" (Fuller, 1989)) and human digestive tract was amply experimented and seems to be an interesting solution to orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group. Nevertheless, our aim is to test clinical efficiency of two new probiotics strains. Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21) and safety (Adverse Events) in very premature babies.
Duration of Parenteral Nutrition
Dietary Supplement: Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns|
- Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition [ Time Frame: at D14 and D21. ]
- Age when Enteral Nutrition reaches 50% of Nutritional needs.
- Incidence of Nosocomial Infections.
- Composition of Colic Flora.
- Fecal Calprotectin as Index of Inflammation
|Study Start Date:||April 2004|
|Study Completion Date:||June 2008|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290576
|Nantes University Hospital|
|Nantes, France, 44093|
|Principal Investigator:||Dominique Darmaun, MD||Nantes UH|