Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein (Rose)
The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants|
- Growth parameters [ Time Frame: 2nd, 4th and 6th months ] [ Designated as safety issue: Yes ]
- Clinical Tolerance [ Time Frame: 3 days before the 2nd and 6th months ] [ Designated as safety issue: No ]
- Atopic diseases (eczema atopic, asthma) [ Time Frame: 2nd and 6th months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Experimental: Modilac Rose 1
Infant formula with partially hydrolysed rice protein
Other: Modilac Rose 1
Infant formula used for non-breastfed children
Other Name: Modilac Rose 1
This objective will result in the study of non-inferiority of the experimental formula in terms of variation of weight compared with growth curves after 3 to 6 months of exclusive regime with the experimental formula.
Parents provide informed written consent.
4 visits are forecasted in pediatric surgeries: V1(inclusion), V2 (2 months), V3 (4 months) and V4 (6 months). The last visit corresponds to the beginning of the food diversification decided by the pediatrician. Ideally it takes place at 6 months. If the food diversification starts at 4 months, then V3 and V4 constitute the same last visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997971
|Aix les bains, France, 73100|
|Asnieres, France, 92600|
|Besancon, France, 25000|
|Boulogne Billancourt, France, 92100|
|Caen, France, 14000|
|Ecully, France, 69130|
|Lyon, France, 69005|
|Meaux, France, 77100|
|St Priest en Jarez, France, 42270|
|Principal Investigator:||Jean-Philippe Girardet, PhD||Hôpital d'enfants Armand Trousseau|