NCT03346174已完成不适用
Influence of Assisted Autogenic Drainage (AAD) and Bouncing Combined With Assisted Autogenic Drainage (BAAD) on Acid and Non-acid Gastro-oesophageal Reflux (GOR) in Infants < 1 Year
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 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 Assisted Autogenic Drainage (AAD) or bouncing combined with Assisted Autogenic Drainage (BAAD), induces or aggravates acid and non-acid gastro-oesophageal reflux in infants under the age of one year. Infants, referred to the hospital for impedance-pH monitoring are included in this study.
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
- Single (Outcomes Assessor)
盲法说明
Data will be analyzed by an experienced paediatric gastro-enterologist, blinded to the different treatment modalities
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
- •Each child under the age of 1 year, referred for 24 h impedance monitoring to confirm a clinically suspected diagnosis of pathological GOR will be included
排除标准
- •prematurity (gestational age less than 37 weeks),
- •the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
结局指标
主要结局
number of refluxes
时间窗: 20 minutes
次要结局
- number of acid refluxes(20 minutes)
研究者
Filip Van Ginderdeuren
Prof. Dr.
Vrije Universiteit Brussel
研究点 (2)
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