Influence of Expiration Lente Prolongée on Gastro-oesopageal Reflux in Infants Under the Age of 1 Year
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 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 a specific airway clearance technique, l'Expiration Lente Prolongée (ELPr), induces or aggravates gastro-oesophageal reflux in infants under the age of one year. Infants referred to hospital for a multichannel intraluminal impedance pH (pH-MII) monitoring are included in this study. Participation is only possible after signing the informal consent by one of the parents.
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 365 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants under the age of one year and on suspicion of GOR who were referred for 24h impedance-pH monitoring are included in this study.
排除标准
- •prematurity (gestational age less than 37 weeks),
- •the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
研究组 & 干预措施
Expiration Lente Prolongée
In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of 'Expiration Lente Prolongée (ELPr)' . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).
干预措施: expiration lente prolongée (Other)
结局指标
主要结局
number of refluxes
时间窗: 20 minutes
次要结局
未报告次要终点
研究者
Filip Van Ginderdeuren
Prof.Dr.
Vrije Universiteit Brussel