Probiotics Supplementation in Premature Infants

Not Applicable

Completed

• Conditions: Prematurity

• 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

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-23
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-26
• Last Update Posted: 2011-08-29

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

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