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NCT Number: NCT05065424

Premedication for Less Invasive Surfactant Administration Study (PRELISA)

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.

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Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

0 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Parkland Health and Hospital System

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV Atropine and Fentanyl Premedication Arm

Drug

Prior to the LISA procedure, the blinded bedside nurse will infuse IV Atropine, labelled as "Atropine/Placebo," over 1 minute, followed by IV fentanyl, labelled as "Fentanyl/Placebo," over 20 minutes in the presence of blinded respiratory therapist and primary team provider.

After medication infusion, a primary team member will perform Less Invasive Surfactant Administration procedure. Infant vital signs, cerebral Near Infrared Spectroscopy values, pain scores will be monitored and recorded during and for 12 hours after the procedure. Level of respiratory support, oxygen requirement and subsequent need for intubation for 24 hours after the procedure will be obtained from the electronic medical record.

Other names: IV Atropine sulfate and IV Fentanyl citrate

IV Normal Saline Placebo Arm

Drug

Prior to the Less Invasive Surfactant Administration procedure, the blinded bedside nurse will infuse IV Normal Saline, labelled as "Atropine/Placebo," over 1 minute, followed by a second infusion of IV Normal Saline, labelled as "Fentanyl/Placebo," over 20 minutes in the presence of blinded respiratory therapist and primary team provider.

After Normal Saline infusion, primary team member will perform Less Invasive Surfactant Administration procedure. Infant vital signs, cerebral Near Infrared Spectroscopy values, pain scores will be monitored and recorded during and for 12 hours after the procedure. Level of respiratory support, oxygen requirement and subsequent need for intubation for 24 hours after the procedure will be obtained from the electronic medical record.

Primary outcomes

  1. 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

  1. Percent of time spent with cerebral Near Infrared Spectroscopy (NIRS) values <55%

    Time frame: 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 calculated

  2. Procedure first attempt success rate

    Time frame: 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.

  3. Intubation rate

    Time frame: 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.

  4. Mean number of attempts required

    Time frame: At time of LISA procedure

    Procedure attempt defined as introduction of laryngoscope blade into the mouth

  5. Mean duration of bradycardia and hypoxemia events

    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.
    • Duration of events in seconds will be recorded by the respiratory therapist and/ or bedside nurse present during the procedure

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Chiesi Farmaceutici S.p.A.

Registry information

Official study title

Use of Premedication for Less Invasive Surfactant Administration: A Randomized Control Trial

Acronym: PRELISA

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2021
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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