NCT05369494已完成不适用
Tolerance of Infants Fed a Hydrolyzed Infant Formula
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 14
- 主要终点
- Weight Maintenance
研究概览
简要总结
The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant is 0 to 90 days of age at enrollment.
- •Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional
- •Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study
- •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 (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
- •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) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study
排除标准
- •An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development
- •Awareness of a positive drug screen in the mother or participant
- •Suspected maternal substance abuse including alcohol
- •Participation in another study that has not been approved as a concomitant study by AN
- •Participant is receiving oral or inhaled steroids
- •Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
- •Participant has received an amino acid-based formula
结局指标
主要结局
Weight Maintenance
时间窗: Study Day1 to Study Day 28
Change in weight for age z-score
次要结局
- Gastrointestinal Tolerance(Study Day1 to Study Day 28)
- Weight(Study Day1 to Study Day 28)
- Length(Study Day1 to Study Day 28)
研究者
研究点 (14)
Loading locations...
相似试验
已完成
不适用
Tolerance of Infants Fed a Hydrolysate FormulaGastrointestinal ToleranceNCT03628183Abbott Nutrition51
已完成
不适用
Growth and Tolerance of Young Infants Fed Infant FormulaGrowth and ToleranceNCT04105686Abbott Nutrition366
已完成
不适用
Infants Fed Extensively Hydrolyzed Casein-Based Infant FormulasInfant DevelopmentNCT04006236Abbott Nutrition245
已完成
不适用
Healthy Term Infants Fed Milk-Based Infant FormulaToleranceNCT04529759Abbott Nutrition108
已完成
3 期
Growth and Tolerance of Young Infants Fed Infant FormulasInfant NewbornNCT01380886Abbott Nutrition209