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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06318117
Other study ID # 3398-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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