NCT00820833已完成不适用
Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2007年10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
- 230
- 试验地点
- 1
- 主要终点
- mean weight gain
研究概览
简要总结
The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy newborn infant
- •birth weight between 2500g and 4800g
- •singleton birth
- •mother's BMI before pregnancy was between 26 and 25
- •for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age
- •for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age
- •having obtained signed informed consent of legal representative
排除标准
- •body weight smaller than 5th percentile for that gestational age
- •newborn whose mother has diabetes
- •newborn whose mother has a drug dependence during pregnancy
- •newborn currently participating in another trial
结局指标
主要结局
mean weight gain
时间窗: 3 months
次要结局
- blood test assessments; body composition, bone density(9 months)
研究者
研究点 (1)
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