Chest Physiotherapy in Light and Moderate Bronchiolitis in Ambulatory Children Under Two Years of Age - a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Reduction of Kristjansson Respiratory Score
研究概览
简要总结
Randomized trial of chest physiotherapy in outpatients with bronchiolitis under two years of age, during two consecutive seasonal outbreaks.
详细描述
A randomized controlled trial was conducted (following CONSORT Statement) in the Paediatric Emergency Department of Centro Hospitalar Universitário São João-Porto (CHUSJ), a tertiary care hospital, during the period from December to March in 2011 and 2012.
Ethical approval was obtained from the Ethics Committee of Centro Hospitalar Universitário São João-Porto.
Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis based on clinical findings, including wheezing or wheezing with crackles, respiratory distress and alteration of feeding condition, were signalized by the physician who met them at the emergency room.
Then, the main investigator of the study interviewed the caregivers and informed about the aims and procedures of the study, after a formal written consent in accordance with the Declaration of Helsinki was sign by all the caregivers.
Severity grade was established with the Kristjansson Respiratory Score which variate from light to severe, being the light to moderate selected to 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
- None
盲法说明
One control group and one intervention group, where chest physiotherapy is used.
入排标准
- 年龄范围
- 15 Days 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis
排除标准
- •presence of comorbidities, such as cystic fibrosis, neuromuscular, congenital heart disease, prematurity or respiratory distress and all the cases that were admitted into the hospital
研究组 & 干预措施
Control
The participants just received standard medical treatment
Intervention
The participants received medical treatment and chest physiotherapy sessions
干预措施: Chest physiotherapy (Procedure)
结局指标
主要结局
Reduction of Kristjansson Respiratory Score
时间窗: Baseline; after two weeks of treatment
Verified by changes in the Kristjansson Respiratory Score, which is a practical and simple score, that assesses the main signs and symptoms of bronchiolitis, having a good validity and inter-observer reliability.It assigns a value between 0 and 2 to each of the five variables: respiratory rate, chest recession, breath sound, skin colour and general condition. A higher Kristjansson respiratory score indicate a worse respiratory condition.
次要结局
未报告次要终点
研究者
Frederico Ramos Pinto
Principal Investigator
Universidade do Porto