NCT01470768撤回不适用
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas
Mead Johnson Nutrition2 个研究点 分布在 1 个国家开始时间: 2012年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Level of fatty acids in whole blood of infants
研究概览
简要总结
This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0 to 6 months of age inclusive
- •Born at ≥ 37 weeks gestation
- •Birth weight of 2500 g (5 lb 8 oz) or more
- •Infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula OR infants intolerant to breast milk
- •Infants with symptoms suggestive of cow's milk allergy
- •Signed Informed Consent
排除标准
- •Infants who for whatever reasons were not discharged home as per routine
- •Infants with metabolic illness requiring a special formula
- •Infants fed with nasogastric tube
结局指标
主要结局
Level of fatty acids in whole blood of infants
时间窗: 4 months
次要结局
- body weight(4 months)
- Occurrence of allergic manifestations(4 months)
- Occurrence of adverse events(4 months)
- Incidence of gas(4 months)
- Incidence of fussiness(4 months)
- Stool characteristics(4 months)
- Body length(4 months)
- Head Circumference(4 months)
研究者
研究点 (2)
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