Randomized Controlled Trial of Video-Laryngoscopy Intervention or Direct Laryngoscopy for Delivery of Less Invasive Surfactant Administration for Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of first attempt success
研究概览
简要总结
Many preterm babies born between 22-28+6 weeks' estimated gestational age (EGA) need surfactant, a medicine that helps the lungs. The goal of the study is to compare the use of video-based visualization to direct visualization during a procedure called less invasive surfactant administration (LISA). The main questions the study aims to answer are: 1) does one method of visualization have a increased rate of giving the medicine successfully on the first attempt? 2) what benefits are there of each method?
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
- 0 Hours 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born ≤28 weeks GA successfully resuscitated in the delivery room (DR) and maintained on CPAP • Need for surfactant in the first 36 hours of life based on clinical assessment and/or meeting threshold per unit protocol
排除标准
- •Infants born ≥29 weeks GA or
- •Infants with known congenital anomalies or
- •Infants who are determined by the primary care team to receive comfort care only or
- •Infants who are intubated at any time prior to surfactant administration
研究组 & 干预措施
Video Laryngoscopy
A video laryngoscopy will be used to visualize the vocal cords and place the LISA catheter for surfactant administration
干预措施: Video Laryngoscopy (Procedure)
Direct Laryngoscopy
Direct laryngoscopy (no camera) will be used to visualize the vocal cords and place the LISA catheter for surfactant administration
干预措施: Direct Laryngoscopy (Procedure)
结局指标
主要结局
Rate of first attempt success
时间窗: During procedure
次要结局
- Amount of surfactant in stomach at the end of the procedure(within 5 min after procedure)
- Mean maximum fractioned inspired O2 used(during procedure)
- Lowest oxygen saturation during catheter insertion(during procedure)
- Fractionated inspired oxygen (FiO2) at 60 mins post procedure(60 minutes post-procedure)
- Lowest heart rate during catheter insertion(during procedure)
- Cross over to alternative method(during procedure)
- Incidence of intubation at 72 hours post surfactant administration(procedure to 72 hours post-procedure)
- Incidence of pneumothorax(procedure to 72 hours post-procedure)
- Incidence of severe (grade III/IV) intraventricular hemorrhage(Birth to discharge)
- Continuous Positive Expiratory Pressure (CPAP) at 60 mins post procedure(60 minutes post-procedure)
- Intubation during procedure(During Procedure)
- Change in provider during procedure(during procedure)
- Survival to discharge or 90 days(up to 90 days)
- Duration of desaturation below 80% SpO2 (sec),(during procedure)
- Duration of bradycardia (HR <100 bpm)(procedure duration)
- Number of desaturation/bradycardia episodes(during procedure)
- Number of surfactant installation attempts(during procedure)
- Time to completion of surfactant installation(during procedure)
- Time to insertion of thin catheter(during procedure)
研究者
Riti Chokshi, MD
Assistant Professor
University of Texas Southwestern Medical Center