Study to evaluate the Efficacy and Safety of nebulization with Adrenaline and 3% Hypertonic saline vs nebulization with 3% Hypertonic saline alone in Acute Bronchiolitis: A Randomized Controlled Trial.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- 1-To evaluate the efficacy of nebulization with adrenaline and 3% hypertonic saline vs nebulization with 3% hypertonic saline alone.
研究概览
简要总结
Acute Bronchiolitis is a lower respiratory tract viral infection that primarily affects the small airways(bronchioles).RSV is the most common cause.Bronchiolitis remains a significant cause of respiratory disease during the first 2 years of life.Diagnosis of bronchiolitis is largely clinical.Treatment is mostly supportive such as oxygen supplementation and hydration.Antibiotics have proven to be ineffective.Treatment with nebulized adrenaline with 3% hypertonic saline have found to decrease severity of symptoms in infants with acute viral bronchiolitis as well as shorten the duration of hospitalization.It is simple,seemingly efficient and cost effective with excellent safety profile.Hence,more research is warranted for further confirmation and expansion of data to clarify this potential treatment modality.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Month(s) 至 24.00 Month(s)（—）
- 性别
- All
入选标准
- •Admitted patient with a chronological age of 2 months to 24 months, a clinical diagnosis of Acute bronchiolitis and their initial Wang respiratory score will be 3 or higher will be enrolled in this study.
排除标准
- •Attendants not giving consent.
- •Children with prior illness with wheezing.
- •Children with prior use of bronchodilators.
- •Premature infants (<34wks of gestation).
- •Children with congenital heart disease.
- •Children with chronic lung disease.
- •Severe bronchiolitis (either wang CSS >9 or baseline oxygen saturation <85%).
结局指标
主要结局
1-To evaluate the efficacy of nebulization with adrenaline and 3% hypertonic saline vs nebulization with 3% hypertonic saline alone.
时间窗: Evaluation Every 24 Hour
2-To evaluate the safety of nebulization with adrenaline and 3% hypertonic saline vs nebulization with 3% hypertonic saline alone.
时间窗: Evaluation Every 24 Hour
次要结局
- To evaluate the changes in clinical scoring after nebulization with adrenaline & 3% hypertonic saline vs nebulization with 3% hypertonic saline alone(Evaluation Every 24 Hour.)
- To evaluate the changes in average length of hospital stay after nebulization with adrenaline & 3% hypertonic saline vs nebulization with 3% hypertonic saline alone(Evaluation every 24 hour)
研究者
Dr Trigunateet Gupta
Narayan Medical College and Hospital