The Effectiveness of Nebulized 3% Hypertonic Saline With Salbutamol in Acute Bronchiolitis in Hospitalised Children- a Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fit to discharge time
研究概览
简要总结
This study evaluates the effectiveness of nebulized 3% hypertonic saline solution with salbutamol in the treatment of children under 2 years, hospitalised for acute viral bronchiolitis. Half of the participants will receive nebulized 3% hypertonic saline solution with salbutamol three times daily, the other half will receive standard supportive care, which is the cornerstone of the bronchiolitis management.
详细描述
Acute viral bronchiolitis is the most common lower respiratory tract infection in infants up to two years old. Currently there is no effective treatment so standard treatment remains supportive care with supplemental oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion and the provision of fluids.
In recent years some studies have suggested that nebulised hypertonic saline, which improve airway hygiene, may influence the course of the illness and reduce the duration of hospitalisation without significant side effects.
Study protocol: half of the included patients will receive standard treatment for bronchiolitis, which includes only supportive care, the other half will additionally receive nebulized 3% hypertonic saline solution with salbutamol (to avoid potential bronchial obstruction) three times daily.
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
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first episode of bronchiolitis: viral lower respiratory tract infection with signs of airway obstruction (hyperinflated lungs, tachypnea, increased work of breathing) and crepitations on auscultations
- •admission to the hospital
- •Wang CSS between 3 and 9
- •randomisation within 4 hours of admission
排除标准
- •a history or previous episodes of bronchiolitis/bronchitis
- •primary diseases: gastro-oesophageal reflux, chronic cardiac or pulmonary diseases including suspected asthma, immunodeficiency, conditions with hypotonia where more severe course of bronchiolitis is expected
- •premature infants born < 36 weeks of gestation
- •oxygen saturation < 85% and patients requiring admission to high dependency or intensive care units at presentation
研究组 & 干预措施
hypertonic saline
4 ml of nebulized 3 % hypertonic saline + salbutamol 0,03 ml/kg every 8 hours for the time of hospitalisation and standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration)
干预措施: nebulized 3% hypertonic solution (Drug)
结局指标
主要结局
Fit to discharge time
时间窗: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Fit to discharge time: as the point (measured in hours) at which the infant was feeding adequately (taking \>75% of their usual intake) and had been in air with a saturation of at least 92% for 6 h.
次要结局
- Number of participants transferred to the intensive care unit (ICU)(Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time)
- Duration of hospitalisation(Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years)
- Number of participants with treatment related adverse events assessed by questionnaire(Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time)
- Number of patients readmitted to the hospital because of the same diagnose(Through study completion - estimated to 2 years; the patients will be assessed up to one month after discharge)
- Comparison of fit to discharge time between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.(Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years)
- Duration of hypoxia(Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years)
- Clinical severity score (CSS) assessed by Wang score(Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time)
- Comparison of hypoxia duration between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.(Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years)
- Number of participants with treatment related adverse events assessed by questionnaire: comparison of patients with RSV bronchiolitis and patients with non-RSV bronchiolitis.(through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time)
研究者
Tina Plankar Srovin
MD, PhD
University Medical Centre Ljubljana