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临床试验/NCT02913040
NCT02913040已完成不适用

High Flow Nasal Cannula Therapy for Infants With Bronchiolitis

Princess Amalia Children's Clinic8 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
111
试验地点
8
主要终点
PEWS (Pediatric Early Warning Score) (in points 0-28)

研究概览

简要总结

In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea.

详细描述

In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal Cannula with Low Flow Nasal Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea. The study will take place on the pediatric (Non intensive care) units of 5 different hospitals in the Netherlands.

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
1 Week 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • bronchiolitis PEWS (Pediatric Early Warning Score 0-28) >= 6 oxygen saturation < 92%

排除标准

  • chronic lung disease hemodynamic significant heart disease syndromal disease facial abnormalities

结局指标

主要结局

PEWS (Pediatric Early Warning Score) (in points 0-28)

时间窗: 24 hours

Sustained reduction in PEWS \>= 2 points within 24 hours (min 0- max 28 points)

次要结局

  • Comfort (in points 0-10)(24 hours)
  • duration of hospitalisation in days(15 days)
  • admission to PICU (Pediatric Intensive Care Unit) (yes or no)(5 days)
  • ability to feed (yes or no)(5 days)

研究者

发起方
Princess Amalia Children's Clinic
申办方类型
Other
责任方
Sponsor

研究点 (8)

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