Clinical trial NCT05065424: Premedication for Less Invasive Surfactant Administration Study (PRELISA)
Official title: Use of Premedication for Less Invasive Surfactant Administration: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: 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
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2021-10-04
Enrollment: 58
Sex: ALL
Minimum age (years): 0
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of bradycardia and hypoxemia events during LISA procedure
timeFrame: Time of medication infusion to completion of LISA procedure
Secondary outcomes:
measure: Percent of time spent with cerebral Near Infrared Spectroscopy (NIRS) values <55%
timeFrame: From time of start of LISA procedure to 12 hours after procedure
measure: Procedure first attempt success rate
timeFrame: At time of LISA procedure
measure: Intubation rate
timeFrame: Within 24 hours after LISA procedure
measure: Mean number of attempts required
timeFrame: At time of LISA procedure
measure: Mean duration of bradycardia and hypoxemia events
timeFrame: Time of medication infusion to completion of LISA procedure
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Venkatakrishna Kakkilaya, MD
role: STUDY_DIRECTOR
References:
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