Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- hospital admission within 7 days after the day of enrollment
研究概览
简要总结
This is a prospective, randomized, controlled, double-blinded, clinical trial
Subject : 3mo ~ 24mo. aged infants with bronchiolitis
The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.
详细描述
Randomly assigned to one of three groups
- Group I : nebulized epinephrine + 0.9% saline + placebo
- Group II : nebulized epinephrine + 3% saline + placebo
- Group III : nebulized epinephrine + 0.9% saline + dexamethasone
Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral dexamethasone.
The primary outcome is hospital admission within 7 days after the day of enrollment
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3mo ~ 24mo aged patients with bronchiolitis visit to emergency departments
- •RDAI score 4-15
排除标准
- •< 3mo, > 24mo
- •infants who had received oral or inhaled corticosteroids during the preceding 2 weeks
- •infants with a previous episode of wheezing or a diagnosis of asthma
- •any chronic cardiopulmonary disease
- •immunodeficiency
- •infants needed intubation
- •infants with a previous history of apnea or intubation
- •infants with side effect of dexamethasone
- •infants born at less than 37 weeks of gestation who had a corrected age of less than 6 weeks at presentation
研究组 & 干预措施
0.9% saline + oral placebo
nebulized epinephrine + 0.9% saline + placebo => epinephrine + 0.9% saline
干预措施: 0.9% saline + oral dexamethasone (Drug)
3% saline + oral placebo
nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
干预措施: 3% saline + oral placebo (Drug)
0.9% saline + oral dexamethasone
nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline
干预措施: 0.9% saline + oral dexamethasone (Drug)
结局指标
主要结局
hospital admission within 7 days after the day of enrollment
时间窗: within 7 days
hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department)
次要结局
- Heart rate(baseline, between nebulizer, 60min, 120min, 180min, 240min)
- RDAI score(baseline, between nebulizer, 60min, 120min, 180min, 240min)
- respiratory rate(baseline, between nebulizer, 60min, 120min, 180min, 240min)
- Oxygen saturation(baseline, between nebulizer, 60min, 120min, 180min, 240min)
- unplanned revisit and admission rate after revisit(in 7days)
研究者
Jin Hee Lee
Assistant Professor
Seoul National University Hospital