Reason for Prescribing Rice Infant Formula

NCT06318117 | Completed

• 1 other identifier: 3398-1
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Infant Formula

Keywords

Rice Formula

Outcome Measures

Primary Outcomes (1)

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

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

  1 to 7 months

Secondary Outcomes (9)

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

  up to 365 days of age

• Questionnaire - Diet characteristics

  up to 365 days of age

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

  up to 365 days of age

• Growth z-score

  up to 365 days of age

• Growth z-score

  up to 365 days of age

Study Arms (2)

Rice infant formula started before age of 6 months

After inclusion (V1), infants will return for a V2 visit at 12 months (± 30 days) of age (according to the child's regular appointment calendar). No visit is imposed by the protocol. Anthropometric data from visits to the pediatrician carried out between V1 and V2 will be collected from medical records, as well as the date of cessation of RIF, if applicable. Retrospective data will be collected from medical files (anthropometric data, medical and feeding history) and from parents' and investigator's recall.

Other: Rice infant formula

Rice infant formula started after age of 6 months

After inclusion (V1), infants will return for a V2 visit at 12 months (± 30 days) of age (according to the child's regular appointment calendar). No visit is imposed by the protocol. Anthropometric data from visits to the pediatrician carried out between V1 and V2 will be collected from medical records, as well as the date of cessation of RIF, if applicable. Retrospective data will be collected from medical files (anthropometric data, medical and feeding history) and from parents' and investigator's recall.

Other: Rice infant formula

Interventions

Rice infant formula OTHER

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

Rice infant formula started after age of 6 months; Rice infant formula started before age of 6 months

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

120 infants will be recruited for this study, according to the following inclusion and non-inclusion criteria, including at least 60 infants who started the RIF before the age of 6 months.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mead Johnson Nutrition: lead
• BioFortis: collaborator

Study Sites (17)

Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department

Auxerre, Auxerre, 89011, France

Location

Dr Christine REGIMBART - Private Practice

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

Location

Scm Les Pediatrices Du Pic St Loup

Saint-Clément, DE Riviere, 34980, France

Location

Dr. Anne Sengier - Private Practice

Le Havre, LE Havre, 76600, France

Location

Centre Hospitalier de Montauban - Pediatric Department

Montauban, Montauban, France

Location

Centre Hospitalier Universitaire de Nantes - Pediatric emergency department

Nantes, Nantes, 44093, France

Location

Hôpital NOVO - Pediatric department

Pontoise, Pontoise, 95300, France

Location

Dr Marta Nowak-Mohamed - Private Practice

Vichy, Vichy, 03200, France

Location

Dr Frederic Couttenier Private Practice

Attiches, 59551, France

Location

Elise Foy-Foulkes Private Practice

Boulogne-Billancourt, 92100, France

Location

Dr. Anne Cheve Private Practice

Brest, 29200, France

Location

Dr. Sandra Brancato Private Practice

Brignon, 30190, France

Location

Dr. Karim Abada Private Practice

Foix, 09017, France

Location

Dr. Nellie Houeto Private Practice

Hyères, 83400, France

Location

Dr. Amandine Blasquez Private Practice

Libourne, 33500, France

Location

Dr. Marc Sznajder Private Practice

Paris, 75011, France

Location

Dr. Piotr Gembara Private Practice

Vichy, 03200, France

Location

Study Officials

• Hugues Piloquet, MD

  CHU Nantes Children's chronic disease service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 19, 2024
• Study Start: March 12, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (17)