Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- death
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of heliox is not clear.This study aimed to determine whether ARDS neonate would benefit from heliox when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.
详细描述
Acute respiratory distress syndrome (ARDS) can result in severe hypoxemia refractory to mechanical ventilation, mechanical ventilation including high frequency oscillation ventilation is the main method. But it is partial unuseful.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Minutes 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infant less than 28 days
- •diagnosis of ARDS
- •informed parental consent has been obtained
排除标准
- •major congenital malformations or complex congenital heart disease
- •transferred out of the neonatal intensive care unit without treatment
研究组 & 干预措施
heliox combined with mechanical ventilation (MV)
heliox combined with mechanical ventilation (MV) is given to infant with ARDS
干预措施: heliox combined with MV (Drug)
mechanical ventilation
mechanical ventilation (MV) is given to infant with ARDS
干预措施: MV (Drug)
结局指标
主要结局
death
时间窗: within 100 days
death
次要结局
- Bayley Scales of Infant Development(at 2 months old and 2 years old)
研究者
Ma Juan
Principal Investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University