Premedication for Less Invasive Surfactant Administration Study (PRELISA)
Status:
Not yet recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
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 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 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 using cerebral
Near Infrared Spectroscopy
- To determine the effect of premedication prior to Less Invasive Surfactant
Administration on the need for mechanical ventilation for 24 hours after the procedure