NCT04006236已完成不适用
Growth and Tolerance of Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 31
- 主要终点
- Weight
研究概览
简要总结
This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is judged to be in good health
- •Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks
- •Participant's birth weight was > 2490 g (~5 lbs. 8 oz.)
- •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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study
- •Participant's parent(s) 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
排除标准
- •An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- •Participant is taking and plans to continue taking medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- •Participant participates in another study that has not been approved as a concomitant study by AN.
- •Participant has an allergy or intolerance to any ingredient in the study product
- •Participant has been treated with antibiotics within 1 week prior to enrollment
结局指标
主要结局
Weight
时间窗: Day of Age (DOA) 14 to 119
Interval weight gain per day
次要结局
- Length(Study Day (SD) 1 to DOA 119)
- Formula Intake(Study Day (SD) 1 to DOA 119)
- Head Circumference(Study Day (SD) 1 to DOA 119)
- Stool Characteristics(Study Day (SD) 1 to DOA 119)
研究者
研究点 (31)
Loading locations...
相似试验
已完成
3 期
Growth and Tolerance of Young Infants Fed Infant FormulasInfant NewbornNCT01380886Abbott Nutrition209
已完成
不适用
Growth and Tolerance of Young Infants Fed Infant FormulaGrowth and ToleranceNCT04105686Abbott Nutrition366
尚未招募
不适用
Preterm Infants Fed a Human Milk FortifierGrowthNCT05551975Abbott Nutrition321
终止
不适用
Growth and Tolerance Trial on Infant Formula With HMOHealthy GrowthNCT04066413FrieslandCampina265
已完成
不适用
Infants Fed a Hydrolyzed Infant FormulaGastrointestinal ToleranceNCT05369494Abbott Nutrition33