Using a Single Dose of Dexamethasone at 0.6mg/kg of Body Weight Versus 0.15 mg/kg of Body Weight for the Treatment of Croup: an Internal Vanguard Randomized Controlled Non-Inferiority Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Return Visits or Readmissions to the Hospital
研究概览
简要总结
Croup is a common childhood respiratory disease that often leads to frequent emergency department visits. It is a viral infection that causes cough, throat, and airway swelling, making breathing difficult. Dexamethasone is a medication that helps to reduce swelling, making breathing easier for children. A standard dose of 0.6mg/kg is used in children. However, a lower amount (due to side effects of steroids in children) has been suggested. We will examine whether 25% less than the standard dose is equally effective in treating croup. Investigators will conduct a clinical study with the support of patients with lived experience (which, in this case, are the parents of the children) to better care for children with croup. If proven, this study can improve the outcome in children with croup.
详细描述
Croup is a common childhood respiratory disease that leads to frequent emergency department (ED) visits. It accounts for 7% and 3% of hospitalization in under 5 and children between 6 months-3 years in North America, respectively. It is a self-limiting viral infection characterized by the sudden onset of a seal-like barking cough, often accompanied by stridor, voice hoarseness, and respiratory distress. Glucocorticoids are a class of corticosteroids with anti-inflammatory properties that help alleviate croup symptoms. While dexamethasone (a type of glucocorticoid) is commonly used to treat croup at 0.6mg/kg, a low dose of 0.15mg/kg (due to adverse events (AEs)) has been suggested to be equally effective. Investigators propose an innovative and multidisciplinary approach to investigate the noninferiority of dexamethasone at 0.15mg/kg versus 0.6mg/kg to treat 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged with clinical diagnosis of croup
排除标准
- •Children who are unable to tolerate or ingest oral dexamethasone,
- •Known hypersensitivity/allergy to dexamethasone,
- •Other causes of stridor (such as acute epiglottitis, bacterial tracheitis, anaphylaxis, foreign body aspiration),
- •Other underlying systemic diseases defined as chronic lung disease, chronic heart disease, chronic kidney disease, and immunodeficiency),
- •Recent exposure to varicella,
- •Treatment with oral or intravenous corticosteroids within the preceding 72 hours.
研究组 & 干预措施
0.15mg/kg dexamethasone
Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg)
干预措施: 0.15 mg/kg dexamethasone (Drug)
Standard practice of 0.6mg/kg dexamethasone
Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg)
干预措施: 0.15 mg/kg dexamethasone (Drug)
结局指标
主要结局
Return Visits or Readmissions to the Hospital
时间窗: Seven days following initial presentation to the ED with croup.
Return visits or readmissions to the hospital within 7 days following initial presentation to the ED with croup.
次要结局
- Adverse Events(within 7 and 30 days of treatment.)