Reason for Prescribing Rice Infant Formula

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infant Formula
• Intervention / Treatment: Other: Rice infant formula

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Amy Benson, MS; Phone Number: 8124298905; Email: amy.benson@reckitt.com
• Study Contact Backup: Name: Jami Walker; Phone Number: 8124297299; Email: jami.walker@reckitt.com

Study Locations

• France
  • Auxerre, France, 89011
    • Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department
    • Contact: Bertrand Soto, MD
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes - Pediatric emergency department
    • Contact: Hugues Piloquet, MD
  • Pontoise, France, 95300
    • Hôpital NOVO - Pediatric department
    • Contact: Mariana Englender, MD
  • Becon-les-Granits
    • Bécon-les-Granits, Becon-les-Granits, France, 49026
      • Dr Christine REGIMBART - Private Practice
      • Contact: Christine Regimbart, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• Child aged between 6 and 11 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; 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; Any commercially available rice infant formula whom the pediatrician has previously deemed, or is deeming it useful to consume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire - Reason for prescribing a RIF in first 6 months of life	o describe the main reason for prescribing a RIF by the pediatrician during the 1st 6 months of life.	up to 365 days of age
Questionnaire - Diet characteristics	To describe the conditions of RIF consumption during the follow-up, and the other main characteristics of the diet.	up to 365 days of age
Growth z-scores body mass index (BMI)-for-age	body mass index (BMI)-for-age	up to 365 days of age
Growth z-score	Weight-for-age z-score	up to 365 days of age
Growth z-score	Length/Height-for-age z-score	up to 365 days of age
Growth z-score	Weight-for-length/height z-score	up to 365 days of age
Growth z-score	Head circumference-for-age z-score	up to 365 days of age
Questionnaire - Evolution of digestive and allergic symptoms	To describe the evolution of digestive and allergic symptoms during follow-up.	up to 365 days of age
Socio-demographic characteristics	To describe the socio-demographic characteristics of the infants' families	up to 365 days of age

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Collaborators: BioFortis
• Investigators: Principal Investigator: Hugues Piloquet, MD, CHU Nantes Children's chronic disease service

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Rice Formula
• Other Study ID Numbers: 3398-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No