跳至主要内容
临床试验/NCT03015051
NCT03015051终止4 期

Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis

IRCCS Burlo Garofolo15 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

High flow (2 L/kg/min) nasal cannula oxygen therapy

干预措施: Oxygen (Drug)

Low flow

Active Comparator

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

发起方
IRCCS Burlo Garofolo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Ronfani

Head of Clinical Epidemiology and Public Health Research Unit

IRCCS Burlo Garofolo

研究点 (15)

Loading locations...

相似试验