Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein (Rose)

Sodilac

Status and phase

Completed

Phase 3

Conditions

Allergy

Growth

Treatments

Other: Modilac Rose 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT00997971

ROS-CL3-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

86 patients

Sex

All

Ages

Under 1 month old

Volunteers

No Healthy Volunteers

Inclusion criteria

Term health infants with gestational age ranging from 37 to 42 weeks
Infants less than 1 month old
Non breastfed children at the inclusion
Growth parameter normal
Apgar score > 5 to 7 minutes
Change in the formula because of digestive troubles (colics, gas, regurgitation) or risks of allergy
Absence of metabolic, nervous or digestive troubles
Absence of digestive haemorrhage, apnea or dizzy turn

Exclusion criteria