A Randomized Double Blinded Placebo Controlled Trial of One Versus Two Doses of Oral Dexamethasone for the Treatment of Acute Asthma Exacerbation in the Pediatric Emergency Department (ED)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Treatment Failure
研究概览
简要总结
Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.
详细描述
A randomized double blinded placebo controlled trial comparing one dose of dexamethasone administered in the Emergency Department with two doses, the first given in the emergency department and the second 24 hours after the index ED visit.
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
- 18 Months 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of asthma defined as at least two (2) prior episodes of respiratory illness characterized by wheezing treated with inhaled beta agonists
排除标准
- •pregnancy
- •severe chronic cardiac, respiratory, neurological or neuromuscular disease
- •complete resolution of symptoms after one treatment of beta agonists
- •severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater
研究组 & 干预措施
Control
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit
干预措施: Dexamethasone (Drug)
Investigational
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit
干预措施: Dexamethasone (Drug)
Investigational
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit
干预措施: placebo (Drug)
结局指标
主要结局
Treatment Failure
时间窗: 5 days
number of patients who experience any of the following outcomes - unplanned hospital admission for asthma symptoms, unplanned ED visit for asthma symptoms, unplanned urgent care visit for asthma symptoms, unplanned primary care physician visit for asthma symptoms, or prescription of a course of steroids
次要结局
- Change in Symptom Severity From Day 1 to Day 5(5 days)
研究者
Geoffrey W Jara-Almonte
Sub-Investigator
New York Presbyterian Brooklyn Methodist Hospital