Treating Wheezing in Children With Hypertonic Saline (TWICS)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Rates of admission to hospital
研究概览
简要总结
Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used in bronchodilator therapy for acute viral wheezing in all children under age 6 years will provide superior symptom relief leading to decreased admission rates from the Emergency Department.
The study will test the efficacy of frequent doses of inhaled bronchodilator co-administered with either 3% hypertonic saline (HS, study group) or 0.9% normal saline (NS, control group) in a prospective, double blind, randomized controlled, multi-centre clinical trial of children under age 6 years presenting to the ED with acute viral-associated wheezing.
详细描述
the brief summary captures the essence of the study
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Days 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age under 6 years
- •History of viral upper respiratory infection within previous 7 days
- •Wheezing or crackles detected on chest auscultation
- •Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.
排除标准
- •History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
- •Severe illness at presentation as defined by any of the following
- •respiratory rate greater than 80/min
- •SaO2 less than 88% in room air
- •need for assisted ventilation
- •Use of nebulized HS within previous 12 hours
- •Presence of active varicella infection.
结局指标
主要结局
Rates of admission to hospital
时间窗: duration of hospital ER stay, an average of 4 hours
Rates of admission to hospital
次要结局
- Improvement in respiratory distress scores after initial protocol treatment in the ED(time from pre-intervention assessment to post-intervention assessment, an average of 2 hours)
- Length-of-stay in the ED in the subgroup of patients not admitted(an average of 6 hours)
- Cumulative dose of bronchodilator administered in ED prior to admission/discharge order(an average of 6 hours)
- Rate of return visit to ED (for respiratory illness) within 14 days of enrollment(14 days)
- Length of hospital stay in the those who are admitted(length of hospital stay, an average of 3 days)
研究者
Dr. Michael Flavin
Professor of Pediatrics
Queen's University