NCT03597113已完成不适用
Growth and Compliance of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 46
- 主要终点
- Weight
研究概览
简要总结
The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 180 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant is experiencing persistent feeding intolerance or allergy and diagnosed wtih Cow's Milk Protein Allergy (CMPA) or other condition where an extensively hydrolyzed formula is deemed appropriate by their healthcare professional
- •Infants using OTC medications, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance
- •Parent(s) of infants enrolled on prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids directed by their healthcare professional, confirm their intention to continue their use during the study until directed by their healthcare professional to discontinue.
- •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 from enrollment through the duration of the study
- •Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrollment through the duration of the study
- •Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB)
排除标准
- •Participation in another study that has not been approved as a concomitant study by AN
结局指标
主要结局
Weight
时间窗: Baseline to Study Day 30
Measured in Kg
次要结局
- Formula Intake(Baseline to Study Day 30)
研究者
研究点 (46)
Loading locations...
相似试验
已完成
3 期
Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy InfantsGrowthNCT00920166Sodilac97
已完成
不适用
Infants Fed Extensively Hydrolyzed Casein-Based Infant FormulasInfant DevelopmentNCT04006236Abbott Nutrition245
已完成
3 期
Tolerance and Compliance of Infants Fed an Hydrolyzed Infant FormulaInfantGastrointestinal IntoleranceNCT01573871Abbott Nutrition25
Unknown
不适用
New Infant Formula Supports Adequate Growth in Healthy InfantsInfant DevelopmentNCT03614468Worthy Health80
已完成
不适用
Growth and Tolerance of Infants Fed Infant FormulasGrowth and ToleranceNCT01808105Abbott Nutrition424