Reason for Prescribing Rice Infant Formula

Last updated: January 28, 2026
Sponsor: Mead Johnson Nutrition
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Rice infant formula

Clinical Study ID

NCT06318117
3398-1
  • Ages 6-36
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Child aged between 6 and 36 months,

  • Child who has already consumed a RIF for at least one month, or still consuming aRIF, or who will benefit from taking a RIF, according to the pediatrician,

  • Legal representatives (parents/guardians) deemed capable of following therequirements of the protocol and have given their consent orally.

Exclusion

Exclusion Criteria:

  • Child with a clinically relevant and significant abnormality in the medical historyor on physical examination;

  • Child who has been hospitalized in a neonatology unit (due to prematurity,malformation or neonatal pathology), or born with a low birth weight (≤ 2,500 g);

  • For children not diversified at the time of starting RIF: mixed feeding with RIF andbreast milk and/or infant formula based on cow's milk;

  • Child born to minor parent(s);

  • Infant or infant's family unable to comply with study protocol or procedures, in thejudgment of the investigator;

  • Participation in any other clinical trial prior to inclusion;

  • Refusal of the Parents / legal representatives of the child, or who do not masterthe French language well enough to understand the information letter.

Study Design

Total Participants: 41
Treatment Group(s): 1
Primary Treatment: Rice infant formula
Phase:
Study Start date:
March 12, 2024
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department

    Auxerre 3035843, Auxerre 89011
    France

    Site Not Available

  • Dr Christine REGIMBART - Private Practice

    Bécon-les-Granits, Becon-les-Granits 49026
    France

    Site Not Available

  • Dr Christine REGIMBART - Private Practice

    Bécon-les-Granits 3033927, Becon-les-Granits 49026
    France

    Site Not Available

  • Scm Les Pediatrices Du Pic St Loup

    Saint-Clément 2981060, DE Riviere 34980
    France

    Site Not Available

  • Scm Les Pediatrices Du Pic St Loup

    St Clement, DE Riviere 34980
    France

    Site Not Available

  • Dr. Anne Sengier - Private Practice

    Le Havre 3003796, LE Havre 76600
    France

    Site Not Available

  • Centre Hospitalier de Montauban - Pediatric Department

    Montauban 2993002, Montauban
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes - Pediatric emergency department

    Nantes 2990969, Nantes 44093
    France

    Site Not Available

  • Hôpital NOVO - Pediatric department

    Pontoise 2986140, Pontoise 95300
    France

    Site Not Available

  • Dr Marta Nowak-Mohamed - Private Practice

    Vichy 2969392, Vichy 03200
    France

    Site Not Available

  • Dr Frederic Couttenier Private Practice

    Attiches, 59551
    France

    Site Not Available

  • Dr Frederic Couttenier Private Practice

    Attiches 3036451, 59551
    France

    Site Not Available

  • Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department

    Auxerre, 89011
    France

    Site Not Available

  • Elise Foy-Foulkes Private Practice

    Boulogne-Billancourt, 92100
    France

    Site Not Available

  • Elise Foy-Foulkes Private Practice

    Boulogne-Billancourt 3031137, 92100
    France

    Site Not Available

  • Dr. Anne Cheve Private Practice

    Brest, 29200
    France

    Site Not Available

  • Dr. Anne Cheve Private Practice

    Brest 3030300, 29200
    France

    Site Not Available

  • Dr. Sandra Brancato Private Practice

    Brignon, 30190
    France

    Site Not Available

  • Dr. Sandra Brancato Private Practice

    Brignon 3030055, 30190
    France

    Site Not Available

  • Dr. Karim Abada Private Practice

    Foix, 09017
    France

    Site Not Available

  • Dr. Karim Abada Private Practice

    Foix 3018174, 09017
    France

    Site Not Available

  • Dr. Nellie Houeto Private Practice

    Hyères, 83400
    France

    Site Not Available

  • Dr. Nellie Houeto Private Practice

    Hyères 3012937, 83400
    France

    Site Not Available

  • Dr. Anne Sengier - Private Practice

    Le Havre, 76600
    France

    Site Not Available

  • Dr. Amandine Blasquez Private Practice

    Libourne, 33500
    France

    Site Not Available

  • Dr. Amandine Blasquez Private Practice

    Libourne 2998517, 33500
    France

    Site Not Available

  • Centre Hospitalier de Montauban - Pediatric Department

    Montauban,
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes - Pediatric emergency department

    Nantes, 44093
    France

    Site Not Available

  • Dr. Marc Sznajder Private Practice

    Paris, 75011
    France

    Site Not Available

  • Dr. Marc Sznajder Private Practice

    Paris 2988507, 75011
    France

    Site Not Available

  • Hôpital NOVO - Pediatric department

    Pontoise, 95300
    France

    Site Not Available

  • Dr Marta Nowak-Mohamed - Private Practice

    Vichy, 03200
    France

    Site Not Available

  • Dr. Piotr Gembara Private Practice

    Vichy, 03200
    France

    Active - Recruiting

  • Dr. Piotr Gembara Private Practice

    Vichy 2969392, 03200
    France

    Site Not Available

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