Premedication for Less Invasive Surfactant Administration Study (PRELISA)

Completed · Phase 4 · Has a placebo group

Conditions studied: Respiratory Distress Syndrome, Newborn

In brief

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.

Key facts

Study ID

NCT05065424

Run by

University of Texas Southwestern Medical Center

People needed

58

Starts

2022-04-06

Expected to finish

2026-03-02

Last updated by the study team

2026-03-16

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants ≥29 weeks gestational age initiated on CPAP in the delivery room or upon admission who require ≥0.25 FiO2.

You may not qualify if…

• 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

Where it is running

• Parkland Health and Hospital System — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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