Use of Premedication for Less Invasive Surfactant Administration: A Randomized Control Trial
Overview
- Phase
- Phase 4
- Intervention
- IV Atropine and Fentanyl Premedication Arm
- Conditions
- Respiratory Distress Syndrome, Newborn
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Number of bradycardia and hypoxemia events during LISA procedure
- Status
- Completed
- Last Updated
- last month
Overview
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 ≥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.
Investigators
Venkat Kakkilaya
Principal Investigator
University of Texas Southwestern Medical Center
Eligibility Criteria
Inclusion Criteria
- •Infants ≥29 weeks gestational age initiated on CPAP in the delivery room or upon admission who require ≥0.25 FiO2.
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
- •Maternal COVID19 infection (RT-PCR positive) within two weeks prior to delivery
Arms & Interventions
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.
Intervention: IV Atropine and Fentanyl Premedication 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.
Intervention: IV Normal Saline Placebo Arm
Outcomes
Primary Outcomes
Number of bradycardia and hypoxemia events during LISA procedure
Time Frame: 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 Outcomes
- 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)