NCT02433600终止不适用
The Effect of Feeding Infant Formula With Enriched Protein Fractions
Mead Johnson Nutrition2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Sequence Recall using 3-dimensional props
研究概览
简要总结
This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton, 0-90 days of age at randomization
- •Term infant with birth weight of a minimum of 2500 grams
- •Receiving at least 75% of the recommended caloric intake from cow's milk-based infant formula
- •Parent or legally authorized representative attending study visits reads, understands, and speaks English
- •Signed Informed Consent and Protected Health Information authorization
排除标准
- •History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- •Feeding difficulties or formula intolerance
- •Infant born small for gestational age
- •Infant born from a mother who was diabetic at childbirth
- •History of seizures or neurological disorders or infant with known head/brain disease/injury
结局指标
主要结局
Sequence Recall using 3-dimensional props
时间窗: 365 days of age
次要结局
- Electroencephalogram response to stimuli(180 days of age)
- Bayley Scales of Infant and Toddler Development, Third Edition(365 days of age)
- Achieved Head Circumference(52 weeks)
- Sequence Recall using 3-dimensional props(300 days of age)
- Infant Behavior Questionnaire Revised, Short(240 days of age)
- Achieved Length(52 weeks)
- Formula Intake(52 weeks)
- Medically-confirmed Adverse Events(52 weeks)
- MacArthur-Bates Communication Development Inventory(365 days of age)
- Achieved Weight(52 weeks)
研究者
研究点 (2)
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