Fentanyl versus placebo before less invasive surfactant administration: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- The primary outcome is the need for mechanical ventilation from the LISA procedure onwards up to 72 h of life.
研究概览
简要总结
For all nonemergent neonatal ventilation,premedicarion is considered mandatory.Awake laryngoscopy is known to be painful and associated with many adverse events.There is still no concensus on whether or not to use sedation during LISA. With sedation LISA procedure become smooth and sucessful but it might compromise the infants respiratory drive which is a prerequisite for LISA. This study will therefore be conducted to determine the efeects of fentanyl on the requirement of mechanical ventilation in the 72hr following the procedure in infants with RDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 2.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm baby with gestational age between 28 to 34 weeks diagnosed with RDS will enroll in this study .
- •RDS will be diagnosed clinically initially and later confirm by chest X ray .
- •A written informed consent will be obtained from the parents of the baby for participation in the study.
排除标准
- •Baby with major congenital anomaly .
- •Intubated at delivery room.
- •Alternative cause of respiratory distress.
结局指标
主要结局
The primary outcome is the need for mechanical ventilation from the LISA procedure onwards up to 72 h of life.
时间窗: The primary outcome is the need for mechanical ventilation from the LISA procedure onwards up to 72 h of life.
次要结局
- Number of laryngoscopy attempts during the procedure(Complications occurring during and after the procedure SpO2 80 percentage hypotension with mean below gestational age bradycardia 100 bpm)