Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
41 participants
OBSERVATIONAL
2024-03-12
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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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
Any commercially available rice infant formula whom the pediatrician has previously deemed, or is deeming it useful to consume.
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.
Rice infant formula
Any commercially available rice infant formula whom the pediatrician has previously deemed, or is deeming it useful to consume.
Interventions
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Rice infant formula
Any commercially available rice infant formula whom the pediatrician has previously deemed, or is deeming it useful to consume.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Months
36 Months
ALL
Yes
Sponsors
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BioFortis
OTHER
Mead Johnson Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Hugues Piloquet, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Nantes Children's chronic disease service
Locations
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Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department
Auxerre, Auxerre, France
Dr Christine REGIMBART - Private Practice
Bécon-les-Granits, Becon-les-Granits, France
Scm Les Pediatrices Du Pic St Loup
Saint-Clément, DE Riviere, France
Dr. Anne Sengier - Private Practice
Le Havre, LE Havre, France
Centre Hospitalier de Montauban - Pediatric Department
Montauban, Montauban, France
Centre Hospitalier Universitaire de Nantes - Pediatric emergency department
Nantes, Nantes, France
Hôpital NOVO - Pediatric department
Pontoise, Pontoise, France
Dr Marta Nowak-Mohamed - Private Practice
Vichy, Vichy, France
Dr Frederic Couttenier Private Practice
Attiches, , France
Elise Foy-Foulkes Private Practice
Boulogne-Billancourt, , France
Dr. Anne Cheve Private Practice
Brest, , France
Dr. Sandra Brancato Private Practice
Brignon, , France
Dr. Karim Abada Private Practice
Foix, , France
Dr. Nellie Houeto Private Practice
Hyères, , France
Dr. Amandine Blasquez Private Practice
Libourne, , France
Dr. Marc Sznajder Private Practice
Paris, , France
Dr. Piotr Gembara Private Practice
Vichy, , France
Countries
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Other Identifiers
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3398-1
Identifier Type: -
Identifier Source: org_study_id
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