Heated Humidified High Flow Nasal Cannula (HHHFNC) For Acute Moderate to Severe RSV-Bronchiolitis in Infants Younger Than 3 Months Old: Early Versus Rescue
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- The rate of Pediatric Intensive Care Unit (PICU) admissions
研究概览
简要总结
The enrolled RSV-bronchiolitis patients will be randomized into two arms , the early HHHFNC group and the standard therapy group with rescue HHHFNC to study the efficacy of this treatment.
详细描述
Setting:
The study will be conducted between June 2017 and June 2020 in the short stay unit of the Pediatric Emergency Center (PEC) of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. Infants aged ≤3 months presenting to the unit for treatment of viral bronchiolitis with positive RSV test will be eligible for the study.
Procedure:
Eligible patients will be enrolled after obtaining written consent. For patients who consent, plain chest radiography, and nasopharyngeal swabs will be taken for RSV detection. If the patient has a positive RSV rapid antigen test, patients will be randomized in one of the study arms. Adverse effects in each group will be carefully monitored and documented.
Study Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously healthy infants with age 0-3 months and gestational age ≥30 weeks admitted to the short stay unit with RSV positive bronchiolitis and clinical severity score ≥4 on Wang clinical severity scale.
排除标准
- •Gestational age less than 30 weeks.
- •Previous history of wheezing.
- •Use of steroid within 48 hours of presentation.
- •History of chronic lung disease.
- •Infants admitted directly to ICU.
- •Prior invasive or non-invasive ventilatory support.
- •Tracheostomy.
- •Nasogastric tubes in situ on admission.
- •Upper airway abnormality (like choanal atresia and midfacial anomalies).
- •Immunodeficient children.
- •History of cardiac disease, renal disease or liver disease.
- •History of neuromuscular disorder.
结局指标
主要结局
The rate of Pediatric Intensive Care Unit (PICU) admissions
时间窗: Through study completion, an average of 3 year
The rate of Pediatric Intensive Care Unit admissions
次要结局
- Percentage of revisit, infirmary short-stay and admission to the hospital or PICU(2 weeks after discharge)
- Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED(1 hour after starting of rescue HHHFNC)
- Bronchiolitis Severity Score (BSS)(Up to 72 hours)
- Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)(Up to 72 hours)
- Mean length of stay (LOS)(Through study completion, an average of 3 year)