Physiotherapy Including Frequent Changes of Body Position and Stimulation to Physical Activity for Infants With Bronchiolitis and Other Acute Respiratory Infections - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Time to improvement
研究概览
简要总结
Children who are in a hospital with respiratory distress often have difficulty breathing, have thick mucus, and may find it hard to eat normally. Sometimes physical therapy is used to treat these children, but it is not entirely known which methods help the children's condition. The aim of this study is to evaluate the most common physiotherapy treatment method that is currently in use in Sweden for infants who are hospitalized with a lower respiratory infection.
详细描述
All children under 2 years of age who are admitted to the hospital for a respiratory infection and who have previously been essentially healthy are asked to participate. The infants will be randomized to 3 groups, 1 control group and 2 intervention groups. The infants in the control group will receive the standard care at the clinic. In one intervention group the parents will receive instructions how to vary their child body position regularly, and in the other intervention group the child will receive physiotherapy regularly and the parents will carry out some treatment. Further actions in the form of inhalations or stimulation of deep breathing, will be used when needed. The children will be observed following a structured observational protocol regularly throughout the hospital stay.
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 (Investigator)
盲法说明
Randomisation is carried out with sealed envelopes that are only opened just before intervention starts.
There are different care givers who carry out the observations and who perform the interventions.
入排标准
- 年龄范围
- 0 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants hospitalized because of respiratory infections such as bronchiolitis, pneumonia or other airway obstructions.
- •Age 0-24 months
- •Born in gestation week 35 or later.
- •Guardians understand written Swedish, English, Arabic or Persian
排除标准
- •Previous cardiac or respiratory disease
- •hospitalized more than 24 hours on this occasion
结局指标
主要结局
Time to improvement
时间窗: Baseline, after 20 minutes, and every third hour up to discharge from hospital, no more than two weeks
First improvement regarding any of the following: Wang respiratory score, use of supplemented oxygen, use of supplemented high air flow, use of tube feeding, hospital stay
次要结局
- oxygen saturation(Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes)
- respiratory rate(Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes)
- Lung complications(At discharge from the ward, no more than two weeks)
- Heart rate(Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes)
- General condition, parents' assessment(Baseline and every third hour up to discharge from hospital, no more than two weeks)