NCT02124863已完成不适用
Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR) 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
- 67
- 试验地点
- 1
- 主要终点
- Number of Refluxes
研究概览
简要总结
The purpose of this study is to determine whether Intrapulmonary Percussive Ventilation ( airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from 0 to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infants from 0 to 12 months
- •impedance monitoring
排除标准
- •gestational age < 24w
- •anti-reflux medication
- •Nissen fundoplication
- •no parental consent
研究组 & 干预措施
Intrapulmonary Percussive Ventilation
Experimental
number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding
干预措施: Intrapulmonary Percussive Ventilation (Device)
结局指标
主要结局
Number of Refluxes
时间窗: during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.
Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV
次要结局
未报告次要终点
研究者
Filip Van Ginderdeuren
PT, Drs
Vrije Universiteit Brussel
研究点 (1)
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