NCT02128867已完成不适用
Influence of Bouncing, Assisted Autogenic Drainage (AAD) and Bouncing and AAD (BAAD) on Gastro-oesophageal Reflux ( GOR ), Oxygen Saturation (SaO2) and Heart Rate in Infants From 0 to 12 Months
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
- 159
- 试验地点
- 2
- 主要终点
- Number of Refluxes
研究概览
简要总结
The purpose of this study is to determine whether three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 365 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infants < 1 year
- •acid reflux monitoring
排除标准
- •gestational age <24 w
- •anti-reflux medication
- •Nissen fundoplication
- •no parental consent
研究组 & 干预措施
Assisted Autogenic Drainage (AAD)
Experimental
airway clearance technique for infants :Assisted Autogenic Drainage
干预措施: Assisted Autogenic Drainage (AAD) (Other)
bouncing and AAD
Experimental
airway clearance technique for infants : bouncing combined with AAD
干预措施: bouncing and AAD (Other)
bouncing
Experimental
bouncing . intervention to relax the infant
干预措施: bouncing (Other)
结局指标
主要结局
Number of Refluxes
时间窗: 15 minutes
number of refluxes will be counted over a period of 15 minutes ( treatment time )
次要结局
- Duration of Reflux Episodes(15 minutes)
研究者
Filip Van Ginderdeuren
PT, Drs.
Vrije Universiteit Brussel
研究点 (2)
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