Probiotics Supplementation in Premature Infants
Not Applicable
Completed
- Conditions
- Prematurity
- Interventions
- Dietary Supplement: Probiotic supplementation
- Registration Number
- NCT01379417
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 199
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maltodextrin Probiotic supplementation Maltodextrin Probiotic B lactis/B longum Probiotic supplementation Bifidobacterium lactis + Bifidobacterium longum Probiotic B longum Probiotic supplementation Bifidobacterium longum Probiotic B lactis Probiotic supplementation Bifidobacterium lactis
- Primary Outcome Measures
Name Time Method Weight (g) From 4 to 6 weeks after inclusion
- Secondary Outcome Measures
Name Time Method Growth between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period) measured by:
* weight gain (g/day)
* height (cm/week)
* head circumference(cm/week)
Trial Locations
- Locations (3)
Service de Nénatologie, Hôpital Femme Mère Enfant
🇫🇷Bron, France
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
🇫🇷Lyon, France
Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, France