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Completed

NCT Number: NCT06318117

Reason for Prescribing Rice Infant Formula

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.

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Key information

Conditions

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department, Auxerre, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child aged between 6 and 36 months,
  • Child who has already consumed a RIF for at least one month, or still consuming a RIF, or who will benefit from taking a RIF, according to the pediatrician,
  • Legal representatives (parents/guardians) deemed capable of following the requirements of the protocol and have given their consent orally.

Exclusion criteria

  • Child with a clinically relevant and significant abnormality in the medical history or 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 and breast 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 the judgment 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 master the French language well enough to understand the information letter.

Treatment and study plan

Rice infant formula

Other

Any commercially available rice infant formula whom the pediatrician has previously deemed, or is deeming it useful to consume.

Primary outcomes

  1. Questionnaire - reason for prescribing a RIF during the 1st year of life.

    Time frame: 1 to 7 months

    The main objective is to describe the main reason for prescribing a RIF by the pediatrician during the 1st year of life.

Secondary outcomes

  1. Questionnaire - Reason for prescribing a RIF in first 6 months of life

    Time frame: up to 365 days of age

    o describe the main reason for prescribing a RIF by the pediatrician during the 1st 6 months of life.

  2. Questionnaire - Diet characteristics

    Time frame: up to 365 days of age

    To describe the conditions of RIF consumption during the follow-up, and the other main characteristics of the diet.

  3. Growth z-scores body mass index (BMI)-for-age

    Time frame: up to 365 days of age

    body mass index (BMI)-for-age

  4. Growth z-score

    Time frame: up to 365 days of age

    Weight-for-age z-score

  5. Growth z-score

    Time frame: up to 365 days of age

    Length/Height-for-age z-score

  6. Growth z-score

    Time frame: up to 365 days of age

    Weight-for-length/height z-score

  7. Growth z-score

    Time frame: up to 365 days of age

    Head circumference-for-age z-score

  8. Questionnaire - Evolution of digestive and allergic symptoms

    Time frame: up to 365 days of age

    To describe the evolution of digestive and allergic symptoms during follow-up.

  9. Socio-demographic characteristics

    Time frame: up to 365 days of age

    To describe the socio-demographic characteristics of the infants' families

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Collaborators

  • BioFortis

Registry information

Official study title

Observational Study on the Use of Infant Formulas Based on Rice Protein Hydrolysate in Real Life Conditions

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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