NCT01573871已完成3 期
Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Weight maintenance
研究概览
简要总结
The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 180 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant is 0 to 180 days of age
- •Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
- •Infant has not consumed an extensively hydrolyzed infant formula
- •Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
- •Infant is not receiving steroids.
- •Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
- •Parent(s) confirm their intention not to administer solid foods or juices to their infant through the duration of the study.
- •Parent(s) confirm their intention not to administer vitamin or mineral during the study
排除标准
- •Participation in another study
结局指标
主要结局
Weight maintenance
时间窗: 14 days
次要结局
- Formula volume intake(14 days)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
3 期
Tolerance of Healthy Term Infants Fed Infant Formulas #4Healthy Term InfantsNCT01155414Abbott Nutrition168
已完成
3 期
Tolerance of Healthy Term Infants Fed Infant Formulas #3Gastrointestinal ToleranceNCT00977964Abbott Nutrition270
已完成
2 期
Tolerance of Healthy Term Infants Fed Infant FormulasInfant, NewbornNCT00705562Abbott Nutrition190
已完成
不适用
Tolerance of Healthy Infants Fed Infant FormulasGastrointestinal ToleranceNCT02401217Abbott Nutrition126
已完成
2 期
Tolerance of Healthy, Term Infants to Infant FormulasHealthyNCT00543673Abbott Nutrition180