Comparison of 3% Normal Saline Nebulization Versus Steroid Nebulization in the Treatment of Bronchiolitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- efficacy of 3% hypertonic saline in acute brochiolitis
研究概览
简要总结
To compare the efficacy of 3% normal saline nebulization and steroid nebulization in the treatment of bronchiolitis in infants.
详细描述
Comparison of 3% normal saline nebulization versus steroid nebulization in the treatment of bronchiolitis Abstract Objectives: To compare the efficacy of 3% normal saline nebulization and steroid nebulization in the treatment of bronchiolitis in infants.
Study Design: Randomized Controlled Trial Place and duration of study: This study was conducted at the Department of Pediatrics, Mardan Medical Complex, Mardan from 15th of November 2022 to 15th of March 2023.
Methods: A total of 60 infants between the ages of 3 to 12 months admitted in the pediatric unit with bronchiolitis were equally randomized into 2 groups. Patients in Group-A were nebulized with 3% normal saline while patients in Group-B were nebulized with steroid and salbutamol, 3 times a day at intervals of 8 hours until they improved enough for discharge. Assessment was done at 0, 12, 24, 48 and 72 hours using respiratory distress assessment instrument. Primary outcome was efficacy of the treatment defined as number of patients discharged from hospital in ≤ 72 hours after start of treatment. Efficacy between the 2 groups was compared by applying the chi-square test, p ≤0.05 was considered statistically significant.
Keywords: 3% normal saline, Bronchiolitis, Nebulization, Pediatric intensive care unit, Steroids.
Introduction:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients in Group-A were nebulized with 3% normal saline
Patients in Group-A were nebulized with 3% normal saline 3 times a day at intervals of 8 hours until they improved enough for discharge
干预措施: 3% normal saline (Drug)
patients in Group-B were nebulized with steroid and salbutamol with 0.9% normal saline
patients in Group-B were nebulized with steroid (beclomethasone dipropionate 400 μg/day in 3 divided doses) and salbutamol with 0.9% normal saline 3 times a day at intervals of 8 hours until they improved enough for discharge
干预措施: steroid(beclomethasone dipropionate 400 μg/day) and salbutamol with 0.9% normal saline (Drug)
结局指标
主要结局
efficacy of 3% hypertonic saline in acute brochiolitis
时间窗: discharged from hospital in ≤ 72 hours after start of treatment
Primary outcome was efficacy of the treatment defined as number of patients discharged from hospital in ≤ 72 hours after start of treatment. Efficacy between the 2 groups was compared by applying the chi-square test, p ≤0.05 was considered statistically significant.
次要结局
未报告次要终点
研究者
faizan sadiq
faizan sadiq,principal investigator, post graduate resident in pediatrics
Mardan Medical Complex