Clinical trial NCT06318117: Reason for Prescribing Rice Infant Formula
Official title: Observational Study on the Use of Infant Formulas Based on Rice Protein Hydrolysate in Real Life Conditions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infant Formula
Keywords: Rice Formula
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
First posted: 2024-03-19
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Questionnaire - reason for prescribing a RIF during the 1st year of life.
timeFrame: 1 to 7 months
Secondary outcomes:
measure: Questionnaire - Reason for prescribing a RIF in first 6 months of life
timeFrame: up to 365 days of age
measure: Questionnaire - Diet characteristics
timeFrame: up to 365 days of age
measure: Growth z-scores body mass index (BMI)-for-age
timeFrame: up to 365 days of age
measure: Growth z-score
timeFrame: up to 365 days of age
measure: Growth z-score
timeFrame: up to 365 days of age
measure: Growth z-score
timeFrame: up to 365 days of age
measure: Growth z-score
timeFrame: up to 365 days of age
measure: Questionnaire - Evolution of digestive and allergic symptoms
timeFrame: up to 365 days of age
measure: Socio-demographic characteristics
timeFrame: up to 365 days of age
Other outcomes:
Locations:
city: Bécon-les-Granits
country: France
facility: Dr Christine REGIMBART - Private Practice
state: Becon-les-Granits
city: St Clement
country: France
facility: Scm Les Pediatrices Du Pic St Loup
state: DE Riviere
city: Attiches
country: France
facility: Dr Frederic Couttenier Private Practice
city: Auxerre
country: France
facility: Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department
city: Boulogne-Billancourt
country: France
facility: Elise Foy-Foulkes Private Practice
city: Brest
country: France
facility: Dr. Anne Cheve Private Practice
city: Brignon
country: France
facility: Dr. Sandra Brancato Private Practice
city: Foix
country: France
facility: Dr. Karim Abada Private Practice
city: Hyères
country: France
facility: Dr. Nellie Houeto Private Practice
city: Le Havre
country: France
facility: Dr. Anne Sengier - Private Practice
city: Libourne
country: France
facility: Dr. Amandine Blasquez Private Practice
city: Montauban
country: France
facility: Centre Hospitalier de Montauban - Pediatric Department
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - Pediatric emergency department
city: Paris
country: France
facility: Dr. Marc Sznajder Private Practice
city: Pontoise
country: France
facility: Hôpital NOVO - Pediatric department
city: Vichy
country: France
facility: Dr Marta Nowak-Mohamed - Private Practice
city: Vichy
country: France
facility: Dr. Piotr Gembara Private Practice
Study officials:
affiliation: CHU Nantes Children's chronic disease service
name: Hugues Piloquet, MD
role: PRINCIPAL_INVESTIGATOR
References: