Premedication for Less Invasive Surfactant Administration Study (PRELISA) (PRELISA)
Respiratory Distress Syndrome, Newborn
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn focused on measuring Premedication for Less Invasive Surfactant Administration, Fentanyl and Atropine for Less Invasive Surfactant Administration, Cerebral Near Infrared Spectroscopy monitoring in neonates, Premedication for LISA, Fentanyl and Atropine for LISA, Cerebral NIRS monitoring in neonates
Eligibility Criteria
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
Sites / Locations
- Parkland Health and Hospital SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
IV Atropine and Fentanyl Premedication Arm
IV Normal Saline Placebo Arm
Participants will receive premedication regimen of 20 micrograms/kilogram intravenous atropine and 0.5 micrograms/kilogram intravenous fentanyl prior to performance of LISA.
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.