Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 14
- 主要终点
- Delay for obtention of healing defined by all of these parameters at least 8 hours in a row : pulse oxymétry >94% AND normal feeding AND specific respiratory distress score lower than one as described in the protocol AND normal respiratory rate
研究概览
简要总结
The purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age.
详细描述
Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the majority of hospital admissions in young children. It is also probably the most common serious illness of childhood lacking evidence-based treatment. Evidence against the effectiveness of chest physiotherapy with vibration and postural drainage techniques has been described but forced expiratory technique, as described in France, has never been evaluated.
The investigators hypothesised that forced expiratory technique was able to reduce the duration of respiratory distress.
Comparison(s): The investigators compare physiotherapy with forced expiratory techniques to simple aspiration of naso-pharyngeal secretions.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Child aged 15 days to 24 months
- •First acute bronchiolitis
- •Indication of hospitalisation
- •One or more of these criteria : toxic aspect; apnea or cyanosis; respiratory rate > 60/min; pulse oxymetry < 95%; alimentary intake < 2/3 of the needs.
排除标准
- •Prematurity (gestational age < 32 weeks)
- •Brondysplasia
- •Chronic lung disease or congenital heart disease
- •Respiratory distress necessitating admission in the Pediatric Intensive Care Unit (PICU)
- •3 or more chest physiotherapy procedures since hospitalisation
- •Parental refusal
- •Any chest physiotherapy contra-indication
结局指标
主要结局
Delay for obtention of healing defined by all of these parameters at least 8 hours in a row : pulse oxymétry >94% AND normal feeding AND specific respiratory distress score lower than one as described in the protocol AND normal respiratory rate
时间窗: obtention
次要结局
- Safety of the forced expiratory technique(during hospitalisation)
- Comparison of pulse oxymetry before/after chest physiotherapy(during hospitalisation)
- Quality of Life Scale(on discharge)