Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 15
- 主要终点
- Hours of oxygen therapy
研究概览
简要总结
Bronchiolitis is the most common respiratory infection of the lower respiratory tract that affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with bronchiolitis require hospital admission because of poor feeding and/or breathing difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of the techniques of administration of oxygen in bronchiolitis is represented by the high flow (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces breathing load and allows for better nutrition. The main aim of therapy with high flows is to reduce the days of oxygen therapy and the cases of intubation. However, up to now, there have been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review on this topic, updated in May 2013, included only one randomized controlled trial (RCT) on a pilot study of 19 subjects comparing HFNC with oxygen administered via "head box". The oxygen saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs 96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the available evidence is insufficient to determine the effectiveness of HFNC.
The aim of this study is to evaluate in a large number of cases the effectiveness of treatment with high flow versus standard treatment, in children with bronchiolitis referred to a Pediatric Emergency Department.
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
- — 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of bronchiolitis
- •age >28 days and <6 months
- •Oxygen saturation (SaO2) <92%
- •respiratory rate >60 breaths/min
- •dyspnea with respiratory distress assessment instrument (RDAI) score ≥8
- •daily milk or food intake less than 2/3 than normally assumed
排除标准
- •chronic diseases or syndromes
- •respiratory diseases (i.e. bronchopulmonary dysplasia)
- •heart diseases
- •preterm birth (before 36 weeks of gestational age)
研究组 & 干预措施
High flow
High flow (2 L/kg/min) nasal cannula oxygen therapy
干预措施: Oxygen (Drug)
Low flow
Low flow (max 3 L/min) oxygen therapy
干预措施: Oxygen (Drug)
结局指标
主要结局
Hours of oxygen therapy
时间窗: up to 5 days
次要结局
- Number of subject admitted in intensive care unit(up to 5 days)
- Number of patients needing intubation(up to 5 days)
- Days of parenteral hydration or nasogastric enteral feeding(up to 5 days)
- Adverse events(up to 15 days)
研究者
Luca Ronfani
Head of Clinical Epidemiology and Public Health Research Unit
IRCCS Burlo Garofolo
