Premedication for Less Invasive Surfactant Administration Study (PRELISA) (PRELISA)

  • STATUS
    Recruiting
  • End date
    May 21, 2023
  • participants needed
    58
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 21 April 2022

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

Details
Condition Respiratory Distress Syndrome, Newborn
Treatment IV Atropine and Fentanyl Premedication Arm, IV Normal Saline Placebo Arm
Clinical Study IdentifierNCT05065424
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Infants ≥29 weeks gestational age between 0-72 hours of life on CPAP for respiratory support who qualify for the LISA procedure as determined by the primary team using Parkland OPTISURF guidelines

Exclusion Criteria

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
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