Observational Study on the Use of Infant Formulas Based on Rice Protein Hydrolysate in Real Life Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 17
- 主要终点
- Questionnaire - reason for prescribing a RIF during the 1st year of life.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Rice infant formula (Other)
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.
干预措施: Rice infant formula (Other)
结局指标
主要结局
Questionnaire - reason for prescribing a RIF during the 1st year of life.
时间窗: 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.
次要结局
- Questionnaire - Reason for prescribing a RIF in first 6 months of life(up to 365 days of age)
- Questionnaire - Diet characteristics(up to 365 days of age)
- Growth z-scores body mass index (BMI)-for-age(up to 365 days of age)
- Questionnaire - Evolution of digestive and allergic symptoms(up to 365 days of age)
- Socio-demographic characteristics(up to 365 days of age)
- Growth z-score(up to 365 days of age)