Safety and Efficacy of Hypertonic Vrs. Normal Saline as Diluent of Salbutamol to Reduce Respiratory Distress in Outpatients With the Clinical Diagnosis of Bronchiolitis During the RSV Epidemic.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations
研究概览
简要总结
We will study if small children who become ill with respiratory distress during the RSV epidemic are better relieved with salbutamol nebulizations diluted in hypertonic (3%), instead of normal (0.9%) saline.
详细描述
In Santiago, Chile, a near collapse of health services is a notorious feature of every winter when vast numbers of small children line for attention because of respiratory distress caused by a probable RSV infection.
Our study will examine if nebulized salbutamol diluted in hypertonic (3%), instead of normal (0.9%) saline, provides better relief in outpatients.
If hypertonic saline proves safe and effective, the patients could be better managed and the pressure for attention diminished at a low cost, by a simple change in the saline ampule.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 1 to 24 months
- •Mild to moderate respiratory distress (Tal score below 9)
- •Up to 5 days of respiratory symptoms, including today
- •Expiratory wheezing heard on chest auscultation
- •Indication of salbutamol nebulization treatment by attending physician
排除标准
- •Two prior episodes of wheezing
- •Premature birth (below 38 weeks), if below 6 months of age
- •Lobar pneumonia
- •Body temperature above 38 degree Celsius
- •Use of salbutamol during the previous 6 hours
- •Pulse oxymetry reading below 90%
- •Congenital heart disease
- •Chronic pulmonary disease: Asthma, cystic fibrosis, bronchopulmonary dysplasia
- •Other chronic or genetic condition or disease
研究组 & 干预措施
1
Salbutamol is diluted in hypertonic (3%) saline.
干预措施: Inhalation of salbutamol diluted in hypertonic saline (Drug)
2
Salbutamol is diluted in normal (0.9%) saline.
干预措施: Inhalation of salbutamol diluted in normal saline (Drug)
结局指标
主要结局
Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations
时间窗: 1 hour
次要结局
- Change in the respiratory distress score (Tal) between the basal score and the first nebulization(15 to 20 minutes)
- Change in the respiratory distress score (Tal) between the basal score and the second nebulization(15 to 20 minutes after the first nebulization)
- Change in pulse oxymetry reading between the basal score and after each of the three nebulizations(1 hour)
- Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization(1 hour)