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| Name | Class |
|---|---|
| BioFortis | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rice infant formula | Other | Any commercially available rice infant formula whom the pediatrician has previously deemed, or is deeming it useful to consume. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hugues Piloquet, MD | CHU Nantes Children's chronic disease service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department | Auxerre | Auxerre | 89011 | France | ||
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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 |
| Dr Christine REGIMBART - Private Practice |
| Bécon-les-Granits |
| Becon-les-Granits |
| 49026 |
| France |
| Scm Les Pediatrices Du Pic St Loup | Saint-Clément | DE Riviere | 34980 | France |
| Dr. Anne Sengier - Private Practice | Le Havre | LE Havre | 76600 | France |
| Centre Hospitalier de Montauban - Pediatric Department | Montauban | Montauban | France |
| Centre Hospitalier Universitaire de Nantes - Pediatric emergency department | Nantes | Nantes | 44093 | France |
| Hôpital NOVO - Pediatric department | Pontoise | Pontoise | 95300 | France |
| Dr Marta Nowak-Mohamed - Private Practice | Vichy | Vichy | 03200 | France |
| Dr Frederic Couttenier Private Practice | Attiches | 59551 | France |
| Elise Foy-Foulkes Private Practice | Boulogne-Billancourt | 92100 | France |
| Dr. Anne Cheve Private Practice | Brest | 29200 | France |
| Dr. Sandra Brancato Private Practice | Brignon | 30190 | France |
| Dr. Karim Abada Private Practice | Foix | 09017 | France |
| Dr. Nellie Houeto Private Practice | Hyères | 83400 | France |
| Dr. Amandine Blasquez Private Practice | Libourne | 33500 | France |
| Dr. Marc Sznajder Private Practice | Paris | 75011 | France |
| Dr. Piotr Gembara Private Practice | Vichy | 03200 | France |