NCT01354366已完成不适用
The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants
Mead Johnson Nutrition24 个研究点 分布在 1 个国家目标入组 511 人开始时间: 2011年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 511
- 试验地点
- 24
- 主要终点
- Body weight measured at each study visit
研究概览
简要总结
This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic 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
- 12 Days 至 16 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton, 12-16 days of age at randomization
- •Term infant with birth weight of a 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 or immunocompromised
- •Feeding difficulties or formula intolerance
结局指标
主要结局
Body weight measured at each study visit
时间窗: 3.5 months
次要结局
- Recall of infant formula intake at each study visit(3.5 months)
- Body Length and Head Circumference measured at each study visit(3.5 months)
- Recall of stool characteristics and tolerance at each study visit(3.5 months)
- Medically-confirmed adverse events collected throughout the study period(3.5 months)
- Parental Product Assessment Questionnaire completed at Study Visit 2(once)
研究者
研究点 (24)
Loading locations...
相似试验
已完成
不适用
Evaluation of Infants Fed an Extensively Hydrolyzed Infant FormulaProtein IntoleranceNCT03884309Abbott Nutrition48
已完成
不适用
Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed FormulaCow's Milk AllergyNCT02450643Société des Produits Nestlé (SPN)83
已完成
不适用
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed FormulaCow Milk AllergyNCT03236207Société des Produits Nestlé (SPN)67
终止
3 期
Growth and Tolerance of Healthy Term Infants to a New Infant FormulaHealthy Term InfantsNCT01137877Abbott Nutrition399
终止
不适用
Growth and Tolerance Trial on Infant Formula With HMOHealthy GrowthNCT04066413FrieslandCampina265