NCT02118935已完成不适用
Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance
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
- 161
- 试验地点
- 7
- 主要终点
- Infant State (Infant behavior over a 72 hour period)
研究概览
简要总结
The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.
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
- 14 Days 至 35 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton, 14-35 days of age at baseline
- •Term infant with birth weight of a minimum of 2500 grams
- •Solely formula-fed
- •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
- •Maternal history of illicit drug use or psychiatric disease
研究组 & 干预措施
Previously marketed cow's milk-based infant formula
Active Comparator
干预措施: Previously marketed cow's mlik-based infant formula (Other)
Marketed cow's milk-based infant formula with prebiotics
Experimental
干预措施: Marketed cow's milk-based infant formula with prebiotics (Other)
结局指标
主要结局
Infant State (Infant behavior over a 72 hour period)
时间窗: 14 weeks
Sleep Measures (Amount of time awake and asleep in a 72 hour period)
时间窗: 14 weeks
次要结局
- Achieved Length(14 weeks)
- Achieved Head Circumference(14 weeks)
- Formula Intake(14 weeks)
- Fecal microbiome(Baseline and 112 days of age)
- Medically-confirmed Adverse Events(14 weeks)
- Salivary Cortisol levels(70 and 120 days of age)
- Temperament - Infant Behavior Questionnaire(Once at 112 days of age)
- Sleep Characteristics(14 weeks)
- Achieved Weight(14 weeks)
研究者
研究点 (7)
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