Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Fraction of inspired oxygen
研究概览
简要总结
With the development of the Intubation Surfactant Extubation technic, in which surfactant is administered during a brief intubation followed by immediate extubation, surfactant therapy can be given during nasal continuous positive airway pressure treatment further reducing need for mechanical ventilation. Preterm newborn babies until eight hours of life, with respiratory distress syndrome, will be randomized to standard delivery of surfactant via endotracheal tube airway inserted after premedication for pain with midazolam and remifentanil or to surfactant delivery via Proseal laryngeal mask airway size 1. The intent is to is to compare efficacy and safety of surfactant administration via two different airways and ventilatory approaches.
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
- 30 Minutes 至 8 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birthweight more than 1000 grams
- •Gestational age more than 28 weeks and less than 35 weeks
- •Chronologic age less than 8 hours
- •Diagnosis of RDS by clinical and radiographic criteria
- •Treated with nasal continuous positive airway pressure and supplemental oxygen more than 30%
- •Parental consent
排除标准
- •Birthweight less than 1000 grams
- •Gestational age more than 28 weeks and less than 35 weeks
- •Chronologic age more than 8 hours
- •Maternal fever or premature rupture of fetal membranes less than 18 hours
- •Diagnosis other than respiratory distress syndrome
- •Babies who require or have already had endotracheal intubation
- •Analgesia and or sedation during the first six hours of life
- •Apgar 5 minute score less than three
- •Babies with congenital anomalies or signs of acute circulatory failure
结局指标
主要结局
Fraction of inspired oxygen
时间窗: three hours
次要结局
- Hormonal evaluation of pain(three hours)
- Proseal laryngeal mask surfactant treatment failure(Six hours)
- Rate of respiratory distress syndrome complications(28 days)