Infant Formula
Conditions
Keywords
Rice Formula
Brief 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.
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.
Interventions
OTHERRice infant formula
Any commercially available rice infant formula whom the pediatrician has previously deemed, or is deeming it useful to consume.
Sponsors
Mead Johnson Nutrition
BioFortis
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire - reason for prescribing a RIF during the 1st year of life. | 1 to 7 months | The main objective is to describe the main reason for prescribing a RIF by the pediatrician during the 1st year of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Socio-demographic characteristics | up to 365 days of age | To describe the socio-demographic characteristics of the infants' families |
| Questionnaire - Evolution of digestive and allergic symptoms | up to 365 days of age | To describe the evolution of digestive and allergic symptoms during follow-up. |
| Questionnaire - Diet characteristics | up to 365 days of age | To describe the conditions of RIF consumption during the follow-up, and the other main characteristics of the diet. |
| Growth z-scores body mass index (BMI)-for-age | up to 365 days of age | body mass index (BMI)-for-age |
| Growth z-score | up to 365 days of age | Weight-for-age z-score |
| Questionnaire - Reason for prescribing a RIF in first 6 months of life | up to 365 days of age | o describe the main reason for prescribing a RIF by the pediatrician during the 1st 6 months of life. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORHugues Piloquet, MD
CHU Nantes Children's chronic disease service
Outcome results
None listed