跳至主要内容
临床试验/CTRI/2025/08/093274
CTRI/2025/08/093274尚未招募3 期

Comparison of weaning from high flow nasal cannula versus direct transition to nasal prong oxygen therapy in children with respiratory distress-a randomized controlled trial.

JIPMER IMRF1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2025年9月2日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
136
试验地点
1
主要终点
To compare the efficacy between weaning from high flow nasal cannula & direct transition from high flow nasal cannula to nasal prong oxygen therapy in terms of improvement in respiratory assessment score in managing children aged 1 month (corrected) to 5 years (completed)with respiratory distress

研究概览

简要总结

Although there are several studies regarding high flow nasal cannula efficiency, there is no consensus on starting maintenance and weaning methods. A deeper understanding of HFNC weaning is essential. As unnecessary slow weaning may prolong hospital stay .They are only few studies regarding weaning strategy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Month(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • All children aged one month to completed 5 years with clinical diagnosis of respiratory distress with respiratory assessment score of 6 or more.

排除标准

  • Children with hemodynamic instability children who need mechanical ventilator support children with known/suspected heart disease children with known/suspected neuromuscular disorder children with suspected upper airway obstruction or foreign body children with suspected air leak children with suspected intestinal obstruction children receiving HFNC therapy via tracheostomy tube children received HFNC within 1 month children who weaned from mechanical ventilation to HFNC.

结局指标

主要结局

To compare the efficacy between weaning from high flow nasal cannula & direct transition from high flow nasal cannula to nasal prong oxygen therapy in terms of improvement in respiratory assessment score in managing children aged 1 month (corrected) to 5 years (completed)with respiratory distress

时间窗: To compare the efficacy between weaning from high flow nasal cannula & direct transition from high flow nasal cannula to nasal prong oxygen therapy in terms of improvement in respiratory assessment score in managing children aged 1 month (corrected) to 5 years (completed)with respiratory distress

次要结局

  • To compare the following between weaning from high flow nasal cannula & direct transition from high flow nasal cannula to nasal prong oxygen therapy in terms of improvement in respiratory assessment score in managing children aged 1 month (corrected) to 5 years (completed)with respiratory distress(to compare the need for invasive mechanical ventilation)

研究者

发起方
JIPMER IMRF
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sisira C R

JIPMER

研究点 (1)

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