NCT02860026撤回不适用
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
Mead Johnson Nutrition34 个研究点 分布在 1 个国家开始时间: 2016年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 34
- 主要终点
- Rate of body weight gain from 14 to 120 days of age
研究概览
简要总结
This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton 10-14 days of age at randomization
- •Term infant with birth weight of minimum of 2500 grams
- •Solely formula fed
- •Signed informed consent and protected health information
排除标准
- •History of underlying metabolic or chronic disease, anemia, or immune compromise
- •Feeding difficulties or formula intolerance
结局指标
主要结局
Rate of body weight gain from 14 to 120 days of age
时间窗: 3.5 months
次要结局
- Recall of infant formula at each study visit(Up to 3.5 months)
- Body length measured at each study visit(Up to 3.5 months)
- Medically confirmed adverse events collected throughout the study period(Up to 3.5 months)
- Head circumference measured at each study visit(Up to 3.5 months)
- Recall of stool characteristics questionnaire measured at each study visit(Up to 3.5 months)
- Recall of gastrointestinal tolerance questionnaire at each study visit(Up to 3.5 months)
研究者
研究点 (34)
Loading locations...
相似试验
终止
不适用
Growth and Tolerance Trial on Infant Formula With HMOHealthy GrowthNCT04066413FrieslandCampina265
已完成
不适用
Growth and Tolerance of Infants Fed Infant FormulasGrowth and ToleranceNCT01808105Abbott Nutrition424
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 Infants Fed Milk-Based Infant FormulaGastro-Intestinal ToleranceNCT03967132Abbott Nutrition189
终止
3 期
Growth and Tolerance of Healthy Term Infants to a New Infant FormulaHealthy Term InfantsNCT01137877Abbott Nutrition399