NCT02626143已完成不适用
Effect of Feeding Mode on Infant Growth and Cognitive Function
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 582
- 试验地点
- 1
- 主要终点
- Auditory Event-related Potential
研究概览
简要总结
This study is intended to compare growth, nutritional status, and brain development in children fed an Investigational cow's milk based formula containing a nutrient-rich whey protein, a standard cow's milk based formula, or fed exclusively breast milk.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 0 Days 至 120 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton, 0-120 days of age at study entry
- •Term infant with birth weight of 2500 to 4500 grams
- •Exclusively feed infant formula or exclusively feeding breast milk
- •Signed informed consent
排除标准
- •History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised.
- •Feeding difficulties or formula intolerance
- •Receiving complementary feedings
研究组 & 干预措施
Breast milk
No Intervention
Investigational nutrient-rich whey protein formula
Experimental
干预措施: Investigational nutrient-rich whey protein formula (Other)
Cow's milk based formula
Active Comparator
干预措施: Cow's milk based formula (Other)
结局指标
主要结局
Auditory Event-related Potential
时间窗: 24 months
Body weight
时间窗: 24 months
Head circumference
时间窗: 24 months
Body length
时间窗: 24 months
次要结局
- Dietary Intake(24 months)
- Medically confirmed adverse events(24 months)
- Body Composition: Deuterium Dilution(12 and 24 months)
- Language development: Rule Inference(10 months)
- Language development: Word Discovery(10 months)
- Blood sample: Metabolic markers(24 months)
- Blood sample: Micronutrient status(24 months)
- Language development: Native3 Phoneme Repertory(12 months)
- Body Composition: Air Displacement Plethysmography(6 months)
- Bayley Scales of Infant and Toddler Development(12 months)
- Sleep measures (Amount of time awake & asleep in a 7-day period)(24 months)
- Language development: MacArthur Communicative Development Inventory(24 months)
研究者
研究点 (1)
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