Effectiveness of N-Acetyl Cysteine vs 3% NaCl nebulisation in children with acute bronchiolitis aged 6 months to 2 years: A randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the mean duration of hospital stay and change in clinical severity score parameters (respiratory rate ,o2 saturation,wheezing,retraction,general condition )
研究概览
简要总结
3% NACL nebulisation is a hypertonic saline inducing an osmotic flow of water into the mucus layer thus increasing mucociliary clearance ,reducing airway edema.
N-acetylcysteine(NAC) nebulisation is an antioxidant that cleaves disulphide bonds by converting them to 2 sulphuryl groups.Thus action results in breakup of mucoprotein in lung mucus.
NAC has been used in treatment studies like in cystic fibrosis, chronic bronchitis,idiopathic pulmonary fibrosis and critically ill states
Need for the study: A few studies show that N-acetyl cysteine can be used in treatment of acute bronchiolitis by decreasing the clinical severity and reduce hospitalisationas compared to 3% NaCl.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 24.00 Month(s)（—）
- 性别
- All
入选标准
- •First episode of respiratory distress associated with wheezing Clinical severity score more than 3 No evidence of bacterial infection.
排除标准
- •Cardiac diseases such as congenital heart disease Preterm birth or history of mechanical ventilation in neonatal period History of pneumonia.
结局指标
主要结局
To evaluate the mean duration of hospital stay and change in clinical severity score parameters (respiratory rate ,o2 saturation,wheezing,retraction,general condition )
时间窗: Assess pre treatment severity before 1st nebulization | Detect early response after 1st dose(after 6 hours of 1st dose),Evaluate ongoing improvement(on day 2,3,4) and final clinal outcome based on reduction of clinical severity score (on day 5)
次要结局
未报告次要终点
研究者
Dr Madhan kumar
Aarupadai veedu medical college and hospital