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Observational Study on the Use of Infant Formulas Based on Rice Protein Hydrolysate in Real Life Conditions
The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest.
The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest. Secondary objectives are to describe the modalities of feeding before, during and after consuming the RIF, to describe the growth of children who have consumed a RIF for at least 1 month, on the basis of anthropometric data collected during the first year of life. As a second intention, this study also aims to monitor the evolution of child's digestive and allergic symptoms, if any, and the sociodemographic characteristics of the infant's family.
Age
0 - 3 years
Sex
ALL
Healthy Volunteers
Yes
Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department
Auxerre, Auxerre, France
Dr Christine REGIMBART - Private Practice
Bécon-les-Granits, Becon-les-Granits, France
Scm Les Pediatrices Du Pic St Loup
Saint-Clément, DE Riviere, France
Dr. Anne Sengier - Private Practice
Le Havre, LE Havre, France
Centre Hospitalier de Montauban - Pediatric Department
Montauban, Montauban, France
Centre Hospitalier Universitaire de Nantes - Pediatric emergency department
Nantes, Nantes, France
Hôpital NOVO - Pediatric department
Pontoise, Pontoise, France
Dr Marta Nowak-Mohamed - Private Practice
Vichy, Vichy, France
Dr Frederic Couttenier Private Practice
Attiches, France
Elise Foy-Foulkes Private Practice
Boulogne-Billancourt, France
Start Date
March 12, 2024
Primary Completion Date
October 31, 2025
Completion Date
December 31, 2025
Last Updated
January 30, 2026
41
ACTUAL participants
Rice infant formula
OTHER
Lead Sponsor
Mead Johnson Nutrition
Collaborators
NCT05868408
NCT05295030
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03456934