Premedication for Less Invasive Surfactant Administration Study (PRELISA)
- Conditions
- Respiratory Distress Syndrome, Newborn
- Interventions
- Drug: IV Normal Saline Placebo ArmDrug: IV Atropine and Fentanyl Premedication Arm
- Registration Number
- NCT05065424
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 58
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IV Normal Saline Placebo Arm 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. IV Atropine and Fentanyl Premedication Arm 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.
- Primary Outcome Measures
Name Time Method Number of bradycardia and hypoxemia events during LISA procedure 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
- Secondary Outcome Measures
Name Time Method Percent of time spent with cerebral Near Infrared Spectroscopy (NIRS) values <55% From time of start of LISA procedure to 12 hours after procedure Cerebral NIRS is a method of noninvasively monitoring cerebral oxygenation. The probes detect a value every 6 seconds and display onto the monitor. Scores between 55-80% are considered within the normal range. Scores less than 55% are considered suboptimal cerebral oxygenation.
* Percent of time spent with low NIRS values \<55% during the 12 hour observation period will be calculatedProcedure first attempt success rate At time of LISA procedure * Procedure attempt is defined as introduction of laryngoscope blade into the mouth.
* Procedure success is defined by ability to insert catheter and administer surfactant, without surfactant aspirated from the stomach after administration.
* Rate will be calculated as a percent of participants in each arm.Intubation rate Within 24 hours after LISA procedure * Rate will be calculated as a percent of participants in each group.
* Participants need for and timing of intubation will be obtained from electronic medical record.Mean number of attempts required At time of LISA procedure Procedure attempt defined as introduction of laryngoscope blade into the mouth
Mean duration of bradycardia and hypoxemia events 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.
* Duration of events in seconds will be recorded by the respiratory therapist and/ or bedside nurse present during the procedure
Trial Locations
- Locations (1)
Parkland Health and Hospital System
🇺🇸Dallas, Texas, United States