NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Efficacy in reducing need of MV
研究概览
简要总结
Infants born between 28 and 32 weeks' gestation with radiological findings and clinical symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) within the first hour of life, were randomized to receive either standard medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life, followed by medical air until NCPAP was needed. The aim of the study was to assess the therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20% oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in terms of reducing the rate of mechanical ventilation (MV).
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
- 28 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inborn infants between 28 and 32 weeks of GA
- •Silverman score > 5,
- •radiological finding of RDS
- •a requirement of inspiratory flow of oxygen (FiO2) > 0,25 (SaO2 ) between 88-95% within the first hour of life.
排除标准
- •major congenital malformations
- •intraventricular hemorrhage (IVH) more than grade 2
- •need of intubation in the delivery room or requirement of FiO2 >0,4 during the first hour of life.
结局指标
主要结局
Efficacy in reducing need of MV
时间窗: 7 days
efficacy in reducing need of intubation for MV in infantans undergoing NCPAP within the first 7 days of life
次要结局
- surfactant need(participants will be followed for the duration of hospital stay, an expected average of 10 weeks)
- major complications of prematurity(participants will be followed for the duration of hospital stay, an expected average of 10 weeks)
- ventilatory assistance(participants will be followed for the duration of hospital stay, an expected average of 10 weeks)
- length of stay(participants will be followed for the duration of hospital stay, an expected average of 10 weeks)