NCT02274883已完成不适用
The Effect of Feeding Infant Formula With Enriched Protein Fractions
Mead Johnson Nutrition3 个研究点 分布在 1 个国家目标入组 451 人开始时间: 2014年11月最近更新:
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
- 451
- 试验地点
- 3
- 主要终点
- Infant cognitive development
研究概览
简要总结
This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
详细描述
To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10-14 days of age
- •Exclusively formula-fed
- •Singleton birth
- •Gestational age of 37-42 weeks
- •Birth weight of 2500g to 4000g
- •Signed Informed Consent Form
排除标准
- •History of underlying metabolic or chronic disease
- •Congenital malformation
- •Condition which is likely to interfere with food ingestion, normal growth, development and evaluation
- •Evidence of feeding difficulties or intolerance
- •Immunocompromised
- •Head/brain disease/injury
研究组 & 干预措施
Enriched Protein Fractions
Experimental
This group is given Infant formula with enriched protein fractions.
干预措施: Enriched Protein Fractions (Dietary Supplement)
Protein Fractions
Active Comparator
This group is given Infant formula with protein fractions.
干预措施: Protein Fractions (Dietary Supplement)
结局指标
主要结局
Infant cognitive development
时间窗: At 12 months of age
Cognitive Scale of Bayley-III is used as the assessment tool.
次要结局
- Infant cognitive development(At 18 months of age)
- Infant language and motor skills(At 4, 6, 9, 12 and 18 months of age)
- Infant acquisition of social and emotional milestones and adaptive development(At 4, 6, 9, 12 and 18 months of age)
- Infant temperament(At 12 and 18 months of age)
- Infant attention capabilities(At 12 and 18 months of age)
- Physical development(At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age)
- Stool characteristics(At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age)
- Formula intake(At 30, 42, 60, 90, 120, 180, 275 and 365 days of age)
- Fecal microbiome and metabolome profile(Average of 14 days of age and 120 days of age)
- Medically-confirmed Adverse Events(Up to 19 months of age)
研究者
研究点 (3)
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