NCT00659854Unknown不适用
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change).
研究概览
简要总结
Cow's milk allergy may be involved in the evolution of sleep apnea in infants. The study will assess the effects of specifies diet changes (i.e. non-milk based formula) on the infant. Specifically , infants will be investigated by sleep studies in order to test this hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polysomnographically diagnosed OSA
- •Age is 2-24 months
- •Clinical suspicion of milk allergy due to findings in the medical history or physical exam
排除标准
- •Congenital defects in the pulmonary and gastrointestinal systems
- •Family history of genetic diseases or familial syndromes
- •Infantile asthma.
结局指标
主要结局
Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change).
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (2)
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