Comparison of Clinical Improvement Using Nebulised Nacetylcysteine Versus Nebulised 3 percent Hypertonic Saline For Acute Bronchiolitis: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- To compare the change in pre and post clinical severity scores in patients with bronchiolitis receiving nebulised N-Acetylcysteine versus Nebulised 3%Hypertonic Saline
研究概览
简要总结
Aim of study-
Comparison of clinical improvement using nebulised N-Acetylcysteine versus Nebulised 3%Hypertonic Saline for Acute Bronchiolitis.
Objectives-
Primary objective-To compare the change in pre and post clinical severity scores in patients with bronchiolitis receiving nebulised N-Acetylcysteine versus Nebulised 3%Hypertonic Saline
Secondary objectives- 1. To compare the duration of hospitalization in both the groups.
2. To compare the duration of ventilation or oxygen support if required among both the groups
Operational definitions-
· Bronchiolitis -Patient <2 years of age with prodromal history consistent with upper respiratory tract infection followed by wheezing and/or crackles on auscultation1
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 2.00 Year(s)（—）
- 性别
- All
入选标准
- •parents have provided consent for their participation in the study with diagnosis of Bronchiolitis hospitalized in NICU or PICU or ward and a clinical severity score of more than 4 on presentation.
排除标准
- •Patients affecting with:
- •congenital cardiac diseases 2.anatomical pulmonary defects 3.bronchopulmonary dysplasia 4.chronic lung disease 5.neuromuscular impairment.
结局指标
主要结局
To compare the change in pre and post clinical severity scores in patients with bronchiolitis receiving nebulised N-Acetylcysteine versus Nebulised 3%Hypertonic Saline
时间窗: From Baseline to end of study at day 5
次要结局
- 1.To compare the duration of hospitalization in both the groups.
研究者
Dr Sujaya Mukhopadhyay
Government Institute of Medical Sciences (GIMS)