NCT01808105已完成不适用
Growth and Tolerance of Young Infants Fed Infant Formulas
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
- 424
- 试验地点
- 50
- 主要终点
- Weight
研究概览
简要总结
To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.
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 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton from full term birth with a gestational age 37-42 weeks
- •Birth weight > 2490 g (~5 lbs 8 oz)
- •Between 0 and 5 days of age
- •Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
- •Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
- •Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
- •No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
排除标准
- •Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
- •Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
- •Treatment with antibiotics
- •Mother intends to use a combination of breast and formula feeding
研究组 & 干预措施
Human Milk
Other
Reference group, breast feeding ad libitum
干预措施: Human Milk (Other)
Control Formula
Active Comparator
Ready to feed infant formula, feed ad libitum
干预措施: Control Formula (Other)
Experimental Formula 1
Experimental
Ready to feed infant formula with human milk oligosaccharides, feed ad libitum
干预措施: Experimental Formula 1 (Other)
Experimental Formula 2
Experimental
Ready to feed infant formula with human milk oligosaccharides, feed ad libitum
干预措施: Experimental Formula 2 (Other)
结局指标
主要结局
Weight
时间窗: Study Day (SD) 14 - 119
Weight gain per day
次要结局
- Length(Study Day (SD) 1, 14, 28, 42, 84 and 119 visits)
- Stool Characteristics(Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits)
- Feeding Tolerance(Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits)
- Head Circumference(Study Day (SD) 1, 14, 28, 42, 84 and 119 visits)
研究者
研究点 (50)
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