A Randomized Controlled Trial on the Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis in Children
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Wood-Downes-Ferres clinical score calculation
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients
- Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis
- Length of Hospitalization
详细描述
This is a double-blind clinical trial that will include all admitted patients with acute bronchiolitis, meeting inclusion criteria, admitted in Pediatrics department Combined Military Hospital Nowshera. Patients will be divided into two groups randomly. Group I patients will be nebulized with drug adrenaline every 6 hours and group II patients will be nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, researchers will record WDF score by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. All data will be recorded on a research Performa including length of hospital stay. Data will be entered on SPSS to calculate results. Independent sample t-test was used to measure the effect of two drugs on the length of hospital stay and improvement of respiratory score with a 95% confidence interval. P value less than 0.05 will be considered as significant.
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
- Double (Participant, Care Provider)
盲法说明
Investigator will make all the protocol and research Performa. Drugs will already be prepared for nebulization and labelled by investigator. Researcher /care provider will nebulize the patients of both groups randomly and record the results accordingly.
入排标准
- 年龄范围
- 1 Month 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children admitted in PICU with acute bronchiolitis
排除标准
- •children with co-exiting illnesses like
- •Congenital Heart Disease
- •Immunodeficiency
- •other Infectious disease like Meningitis, encephalitis, Pneumonia, TORCH
- •Kidneys or liver problem
研究组 & 干预措施
Hypertonic saline nebulization group
First group of patients diagnosed as acute bronchiolitis will be nebulized with hypertonic saline every 6 hours and data will be recorded on a Performa
干预措施: Hypertonic Saline Solution, 1 Ml (Drug)
Adrenaline nebulization group
Second group of patients will be nebulized with adrenaline every 6 hours and data will be recorded on a Performa
干预措施: Adrenaline (Drug)
结局指标
主要结局
Wood-Downes-Ferres clinical score calculation
时间窗: at 24 and 48 hours of treatment
A score of 0-3 mild, 4-6 moderately ill, \>6 severely ill
次要结局
- total length of hospitalization(less than 7 days, 7-10 days, 10-14 days)
研究者
Syed Qamar Zaman
Assistant Professor & Head of Pediatrics Department
Combined Military Hospital, Pakistan