Efficacy of Single Injection of Dexamethasone for Acute Bronchiolitis in Children Younger Than 2 Years Old: A Randomized, Double-Blind, Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- and oxygen saturation greater than or equal to 95% without oxygen
研究概览
简要总结
The purpose of this study was to determine whether a single intramuscular injection of dexamethasone decreased the duration of symptoms of acute bronchiolitis in young children.
详细描述
Acute bronchiolitis is an infection of the lower respiratory tract causing inflammation of the small airways, leading to bronchiolar obstruction. Corticosteroids are frequently prescribed as anti-inflammatory drugs. The usefulness of corticosteroids for this disease remains controversial, despite many randomized controlled trials (RCTs). Recently, a meta-analysis and systemic review showed significant improvement in clinical symptoms, length of hospital stay and duration of symptoms in children with this disease after treatment with various regimens of systemic corticosteroids.
Dexamethasone is a long acting corticosteroid with biologic half-life ranging from 36-72 hours. A single dose of dexamethasone has been the standard recommendation for the treatment of croup which has a similar pathophysiology without evidence of adverse effects. Furthermore, there is no previous report of this single dosage form of dexamethasone for the treatment of acute bronchiolitis in young children.
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
入排标准
- 年龄范围
- 4 Weeks 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 4 weeks - 24 months
- •Has the first episode of wheezing within 7 days
- •Has evidence of viral infection
- •Requires hospital admission; criteria for admission include one of the following: age < 3 months; respiratory rate > 60 breaths/minute for age < 12 months or 50 breaths/minute for > or equal to 12 months; oxygen saturation in room air < 95% and apathy or refuses feeding.
排除标准
- •Initial admission to intensive care unit
- •Initial requirement for endotracheal intubation or mechanical ventilation
- •A previous history of intubation
- •A known history of asthma or response to the first dose of beta2 agonist nebulization
- •A history of prematurity
- •A history of bronchopulmonary dysplasia or chronic lung disease
- •Underlying congenital heart disease or immunodeficiency
- •Receives treatment of any form of corticosteroids within 2 weeks
- •Has contraindication to corticosteroid treatment
结局指标
主要结局
and oxygen saturation greater than or equal to 95% without oxygen
The time from study entry to respiratory distress resolved, which was defined as the following: respiratory rate score of 0 or 1
wheezing score of 0 or 1
retraction muscle score of 0 or 1
次要结局
- The length of hospital stay
- Additional drugs used
- The duration of oxygen therapy
- Emergency visit and hospital readmission within one month after discharge
- Adverse drug events