Reason for Prescribing Rice Infant Formula

Infant Formula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06318117
• Other study ID #: 3398-1
• Status: Not yet recruiting
• Start date: March 30, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Mead Johnson Nutrition
• Contact: Amy Benson, MS
• Phone: 8124298905
• Email: amy.benson[@]reckitt.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 11 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infant Formula

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department	Auxerre
France	Dr Christine REGIMBART - Private Practice	Bécon-les-Granits	Becon-les-Granits
France	Centre Hospitalier Universitaire de Nantes - Pediatric emergency department	Nantes
France	Hôpital NOVO - Pediatric department	Pontoise

Sponsors (2)

Lead Sponsor	Collaborator
Mead Johnson Nutrition	BioFortis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Growth z-scores body mass index (BMI)-for-age	body mass index (BMI)-for-age	up to 365 days of age
Secondary	Growth z-score	Weight-for-age z-score	up to 365 days of age
Secondary	Growth z-score	Length/Height-for-age z-score	up to 365 days of age
Secondary	Growth z-score	Weight-for-length/height z-score	up to 365 days of age
Secondary	Growth z-score	Head circumference-for-age z-score	up to 365 days of age
Secondary	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
Secondary	Socio-demographic characteristics	To describe the socio-demographic characteristics of the infants' families	up to 365 days of age