Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sodilac
- 入组人数
- 86
- 试验地点
- 9
- 主要终点
- Growth parameters
研究概览
简要总结
The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.
详细描述
This objective will result in the study of non-inferiority of the experimental formula in terms of variation of weight compared with growth curves after 3 to 6 months of exclusive regime with the experimental formula.
Parents provide informed written consent.
4 visits are forecasted in pediatric surgeries: V1(inclusion), V2 (2 months), V3 (4 months) and V4 (6 months). The last visit corresponds to the beginning of the food diversification decided by the pediatrician. Ideally it takes place at 6 months. If the food diversification starts at 4 months, then V3 and V4 constitute the same last visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term health infants with gestational age ranging from 37 to 42 weeks
- •Infants less than 1 month old
- •Non breastfed children at the inclusion
- •Growth parameter normal
- •Apgar score > 5 to 7 minutes
- •Change in the formula because of digestive troubles (colics, gas, regurgitation) or risks of allergy
- •Absence of metabolic, nervous or digestive troubles
- •Absence of digestive haemorrhage, apnea or dizzy turn
排除标准
- •Partial breastfed children
- •Infants presenting a cow's milk protein allergy
- •Infants currently participating in another trial
- •Infants presenting an organic disease involving medicinal or surgical treatment
结局指标
主要结局
Growth parameters
时间窗: 2nd, 4th and 6th months
次要结局
- Clinical Tolerance(3 days before the 2nd and 6th months)
- Atopic diseases (eczema atopic, asthma)(2nd and 6th months)