Reason for Prescribing Rice Infant Formula

Mead Johnson Nutrition

Status: Enrolling

Conditions: Infant Formula

Treatments: Other: Rice infant formula

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06318117

3398-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 6 to 36 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Rice infant formula started before age of 6 months

Description:

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.

Treatment:

Other: Rice infant formula

Rice infant formula started after age of 6 months

Description:

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.

Treatment:

Other: Rice infant formula