NCT02111837已完成不适用
Multicenter, Randomized, Double-blind, Parallel-group, Reference-controlled, Safety Pilot Study to Evaluate the Effects of Specific Lipid Fractions-enriched Infant Formulae in Infants Aged 0-4 Months
Société des Produits Nestlé (SPN)8 个研究点 分布在 2 个国家目标入组 199 人开始时间: 2009年11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
- 199
- 试验地点
- 8
- 主要终点
- Mean weight gain (g/day)
研究概览
简要总结
This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.
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
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborn infant
- •Infant is ≤14 days old on day of enrollment
- •Gestational age ≥37 weeks (full term infants)
- •Birth weight ≥2500 g and ≤4500 g
- •Singleton birth
- •Having obtained his/her parents'/legal representative's informed consent
排除标准
- •Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
- •Infant undergoing antibiotic therapy.
- •Re-hospitalization for more than 2 days in the first 14 days of life.
- •Parents not expected to comply with the protocol during the period of study participation.
- •Infants currently participating in another trial
结局指标
主要结局
Mean weight gain (g/day)
时间窗: Enrollment to age 4 months
次要结局
未报告次要终点
研究者
研究点 (8)
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