临床试验/NCT02124863

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.

Vrije Universiteit Brussel2 个研究点分布在 1 个国家目标入组 67 人开始时间: 2013年9月最近更新: 2017年2月10日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Vrije Universiteit Brussel
入组人数: 67
试验地点: 2
主要终点: Number of Refluxes

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

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

发起方

Vrije Universiteit Brussel

申办方类型

Other

责任方

Principal Investigator

主要研究者

Filip Van Ginderdeuren

PT, Drs

Vrije Universiteit Brussel

研究点 (2)

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