Use of Premedication for Less Invasive Surfactant Administration: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Number of bradycardia and hypoxemia events during LISA procedure
研究概览
简要总结
The purpose of this study is to conduct a double blinded randomized control trial to determine the safety and efficacy of using IV fentanyl and atropine prior to Less Invasive Surfactant Administration (LISA) procedure in preterm infants with Respiratory Distress Syndrome compared to the local standard of care to perform this procedure without any premedication.
Hypothesis: In infants greater than or equal to 29 weeks gestational age requiring the Less Invasive Surfactant Administration procedure, premedication with a combination of IV atropine and IV fentanyl will be associated with fewer combined bradycardia events, defined as heartrate less than 100 beats per minute for longer than 10 seconds, and hypoxemia events, defined as saturations less than or equal to 80% for longer than 30 seconds, during the procedure compared with placebo.
Specific Aims:
- To determine if infants ≥29 week GA receiving IV fentanyl and atropine prior to LISA will have a decrease in hypoxemia and bradycardia events during the procedure compared to infants receiving placebo
- To determine if infants ≥29 week GA receiving premedication prior to Less Invasive Surfactant Administration will have higher procedure first attempt success rate compared with infants receiving placebo
- To determine the effect of premedication on cerebral oxygenation compared to placebo during and for 12 hours after Less Invasive Surfactant Administration in infants ≥29 week GA using cerebral Near Infrared Spectroscopy.
- To determine the effect of premedication prior to Less Invasive Surfactant Administration on the need for mechanical ventilation during ≤72 hours of life in preterm infants.
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
- 0 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants ≥29 weeks gestational age initiated on CPAP in the delivery room or upon admission who require ≥0.25 FiO2.
排除标准
- •Infants requiring intubation prior to surfactant therapy
- •Infants with known severe congenital anomalies (including complex congenital heart disease, airway, and central nervous system anomalies)
- •Infants born to mothers with known opioid addiction or in a methadone treatment program
- •Maternal COVID19 infection (RT-PCR positive) within two weeks prior to delivery
研究组 & 干预措施
IV Atropine and Fentanyl Premedication Arm
Participants will receive premedication regimen of 20 micrograms/kilogram intravenous atropine and 0.5 micrograms/kilogram intravenous fentanyl prior to performance of LISA.
干预措施: IV Atropine and Fentanyl Premedication Arm (Drug)
IV Normal Saline Placebo Arm
Participants will receive two intravenous Normal Saline infusions in quantities equivalent to the calculated volumes of atropine and fentanyl for participant's weight prior to performance of LISA.
干预措施: IV Normal Saline Placebo Arm (Drug)
结局指标
主要结局
Number of bradycardia and hypoxemia events during LISA procedure
时间窗: Time of medication infusion to completion of LISA procedure
* Bradycardia events will be defined as heartrate \<100 beats per minute for \>10 seconds. Heartrate will be obtained from the participant's heartrate monitor. * Hypoxemia events will be defined as participant saturation (SpO2) =\<80% for \>30 seconds. SpO2 will be obtained from the participant's pulse oximeter monitor. * Events will be recorded by the respiratory therapist and/ or bedside nurse present during the procedure
次要结局
- Percent of time spent with cerebral Near Infrared Spectroscopy (NIRS) values <55%(From time of start of LISA procedure to 12 hours after procedure)
- Procedure first attempt success rate(At time of LISA procedure)
- Intubation rate(Within 24 hours after LISA procedure)
- Mean number of attempts required(At time of LISA procedure)
- Mean duration of bradycardia and hypoxemia events(Time of medication infusion to completion of LISA procedure)
研究者
Venkat Kakkilaya
Principal Investigator
University of Texas Southwestern Medical Center