NCT02746016已完成不适用
Effect of Formula Supplemented With Oligosaccharides on Infant Behavior
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 26
- 主要终点
- Fussiness
研究概览
简要总结
This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 42 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is in good health as determined from subject's medical history by parent report
- •Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks
- •Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
- •Subject is between 7 and 42 days of age
- •Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation
- •Infant is exclusively formula-fed at time of study entry
- •Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study
- •Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study
排除标准
- •An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development
- •Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- •Subject participates in another study that has not been approved as a concomitant study
- •Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment
- •Subject has been treated with oral antibiotics within 7 days prior to study enrollment
- •Mother intends to use a combination of breast and formula feeding
结局指标
主要结局
Fussiness
时间窗: Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1)
Parent Questionnaires
次要结局
- Gastrointestinal Tolerance(Baseline to SDAY 29)
- Fussiness(Baseline to SDAY 29)
- Hours of daily crying(Baseline to SDAY 29)
- Stool Pattern(Baseline to SDAY 29)
研究者
研究点 (26)
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