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

Sodilac86 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Growth Allergy

Interventions

Modilac Rose 1OTHER

Infant formula used for non-breastfed children

Eligibility

Sex: ALLMax age: 1 Month

Medical Language ↔ Plain English

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: * Partial breastfed children * Infants presenting a cow's milk protein allergy * Infants currently participating in another trial * Infants presenting an organic disease involving medicinal or surgical treatment

Locations (9)

Unnamed facility

Aix-les-Bains, France

Unnamed facility

Asnières, France

Unnamed facility

Besançon, France

Unnamed facility

Boulogne-Billancourt, France

Outcomes

Primary Outcomes

Growth parameters

Time frame: 2nd, 4th and 6th months

Secondary Outcomes

Clinical Tolerance

Time frame: 3 days before the 2nd and 6th months

Atopic diseases (eczema atopic, asthma)

Time frame: 2nd and 6th months

Data from ClinicalTrials.gov

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