Understanding why rice infant formula is prescribed

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

This study looks at why doctors give rice infant formula to babies, especially before six months old, and how it affects their growth and health in the first year of life.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 6 Months to 36 Months
• Sex: All
• Sponsor: Mead Johnson Nutrition (industry)
• Locations: 17 sites (Bécon-les-Granits, Becon-les-Granits and 16 other locations)
• Trial ID: NCT06318117 on ClinicalTrials.gov

What this trial studies

This observational study aims to describe the real-life consumption patterns of rice infant formula (RIF) during the first year of life. It focuses on the reasons pediatricians prescribe RIF, particularly when consumption begins before six months of age. The study will also monitor feeding modalities before, during, and after RIF consumption, track the growth of children who have consumed RIF for at least one month, and assess any digestive or allergic symptoms. Additionally, sociodemographic characteristics of the infant's family will be collected.

Who should consider this trial

Good fit: Ideal candidates include children aged 6 to 36 months who have consumed rice infant formula for at least one month.

Not a fit: Patients who have significant medical abnormalities, were hospitalized in a neonatology unit, or are unable to comply with the study protocol may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safe and effective use of rice infant formula in infants, potentially improving dietary recommendations.

How similar studies have performed: While this study focuses on a specific aspect of infant nutrition, similar observational studies have successfully provided valuable insights into infant feeding practices.

Eligibility criteria

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.

Where this trial is running

Bécon-les-Granits, Becon-les-Granits and 16 other locations

• Dr Christine REGIMBART - Private Practice — Bécon-les-Granits, Becon-les-Granits, France (RECRUITING)
• Scm Les Pediatrices Du Pic St Loup — St Clement, DE Riviere, France (RECRUITING)
• Dr Frederic Couttenier Private Practice — Attiches, France (RECRUITING)
• Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department — Auxerre, France (RECRUITING)
• Elise Foy-Foulkes Private Practice — Boulogne-Billancourt, France (RECRUITING)
• Dr. Anne Cheve Private Practice — Brest, France (RECRUITING)
• Dr. Sandra Brancato Private Practice — Brignon, France (RECRUITING)
• Dr. Karim Abada Private Practice — Foix, France (RECRUITING)
• Dr. Nellie Houeto Private Practice — Hyères, France (NOT_YET_RECRUITING)
• Dr. Anne Sengier - Private Practice — Le Havre, France (RECRUITING)
• Dr. Amandine Blasquez Private Practice — Libourne, France (RECRUITING)
• Centre Hospitalier de Montauban - Pediatric Department — Montauban, France (RECRUITING)
• Centre Hospitalier Universitaire de Nantes - Pediatric emergency department — Nantes, France (RECRUITING)
• Dr. Marc Sznajder Private Practice — Paris, France (RECRUITING)
• Hôpital NOVO - Pediatric department — Pontoise, France (RECRUITING)
• Dr Marta Nowak-Mohamed - Private Practice — Vichy, France (RECRUITING)
• Dr. Piotr Gembara Private Practice — Vichy, France (RECRUITING)

Study contacts

• Principal investigator: Hugues Piloquet, MD — CHU Nantes Children's chronic disease service
• Study coordinator: Amy Benson, MS

Conditions: Infant Formula, Rice Formula