Management of Recurrent Croup: Comparison Between Inhaled Fluticasone and Oral Prednisolone
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Quantity of Recurrent Episodes
研究概览
简要总结
Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of this study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.
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
- None
入排标准
- 年龄范围
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric population: 6 months to 15 years of age
- •2 or more episodes of croup in 12 month period
- •croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress.
排除标准
- •Grade 3 or 4 subglottic stenosis
- •Subglottic hemangioma
- •Posterior laryngeal cleft
- •Recurrent respiratory papillomatosis
- •External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc)
- •Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body
- •Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress
- •Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease.
- •Other medical conditions necessitating chronic steroid utilization
研究组 & 干预措施
Inhaled steroids
Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
干预措施: Fluticasone (Drug)
Oral control
Patient and clinician observation with short term oral prednisolone as needed. Offered at 1mg/kg (body weight) daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
干预措施: Prednisolone IF needed (Drug)
结局指标
主要结局
Quantity of Recurrent Episodes
时间窗: 1 year
Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.
次要结局
- Severity of Croup Episodes(1 year)
研究者
David Brown
Associate Professor of Otorhinolaryngology
University of Michigan