Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

Nantes University Hospital127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

127

Conditions

Duration of Parenteral Nutrition

Interventions

Eligibility

Sex: ALLMin age: 1 DayMax age: 2 Weeks

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition

Time frame: at D14 and D21.

Secondary Outcomes

Age when Enteral Nutrition reaches 50% of Nutritional needs.

Incidence of Nosocomial Infections.

Composition of Colic Flora.

Fecal Calprotectin as Index of Inflammation