NCT02490852已完成不适用
Study of Nutritional Suitability of a New Infant Formula for Term Infants
Ausnutria Hyproca B.V.18 个研究点 分布在 4 个国家目标入组 304 人开始时间: 2015年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 18
- 主要终点
- Weight gain
研究概览
简要总结
This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.
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
- — 至 13 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy full term infant (37-42 weeks of gestational age)
- •Birth weight 2,500 to 4,500 g
- •Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation
- •Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary
- •Informed consent signed by parent(s)/caregiver(s)
排除标准
- •Congenital illness or malformation that may affect infant feeding or normal growth
- •Gastrointestinal disorders
- •Suspected or known allergy to milk protein for formula groups
- •Known food allergies in parents or siblings for formula groups
- •Multiples
- •Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrollment
- •Infant participating in another clinical study
- •Infant's family unable to comply with the protocol according to the investigators's assessment
结局指标
主要结局
Weight gain
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (18)
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