Duration of Parenteral Nutrition
Conditions
Keywords
Digestive and Nutritional Effects, Safety and Growth, Feeding Tolerance
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
1 Days to 2 Weeks
Healthy volunteers
No
Inclusion criteria
1. newborns (\< 2 weeks of life) 2. 32 Weeks of Gestation, 3. weight \< 1500g, 4. Enteral nutrition begun, 5. Clinical stability, 6. Signed consent form from both parents.
Exclusion criteria
1. newborns (\>= 2 weeks of life), 2. weight \>= 1500g, 3. pathology avoiding the start of the enteral nutrition, 4. other pathologies of those due to premature and its complications, 5. No signed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition | at D14 and D21. |
Secondary
| Measure | Time frame |
|---|---|
| Age when Enteral Nutrition reaches 50% of Nutritional needs. | — |
| Incidence of Nosocomial Infections. | — |
| Composition of Colic Flora. | — |
| Fecal Calprotectin as Index of Inflammation | — |
Countries
France
Outcome results
None listed