NCT01585142已完成不适用
Assessment of Growth of Infants Fed With BabyNes System (Single-serve Formulas, Adaptative System)
Société des Produits Nestlé (SPN)4 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2012年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- z-score weight-for-age (WHO Child Growth Standards)
研究概览
简要总结
The purpose of this study is to assess the growth of infants fed with BabyNes System, compared to the World Health Organization Reference, during the first four months of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborn
- •Full term newborn (≥ 37 weeks gestation)
- •Birth weight ≥ 2500 g and ≤ 4500 g
- •Newborn from birth to 14 days of age at the time of enrollment
- •The newborn's mother has voluntarily elected to exclusively formula feed her newborn
- •Having obtained his/her signed legal representative's informed consentHealthy newborn infant
排除标准
- •Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
- •Newborn whose mother's BMI was abnormal (<18.5 or >30kg/m2) at start of pregnancy
- •Newborn whose mother has diabetes of type-1 or type-2
- •Newborn whose mother has a chronic infectious disease
- •Newborn whose parents / caregivers cannot be expected to comply with treatment
- •Newborn currently participating in another nutritional interventional clinical trial (except for vaccination studies)
研究组 & 干预措施
BabyNes system formula
Experimental
干预措施: Test formula (Other)
结局指标
主要结局
z-score weight-for-age (WHO Child Growth Standards)
时间窗: 4 months
次要结局
- Growth(12 months)
- Compliance(12 months)
- Morbidity(12 months)
研究者
研究点 (4)
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