Premedication for Less Invasive Surfactant Administration Study (PRELISA) (PRELISA)

March 12, 2026 updated by: Venkat Kakkilaya, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Parkland Health and Hospital System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 3 days (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: IV Atropine and Fentanyl Premedication Arm

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
Placebo Comparator: 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.
Drug: IV Normal Saline Placebo Arm

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time of medication infusion to completion of LISA procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From time of start of LISA procedure to 12 hours after procedure
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.
At time of LISA procedure
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.
Within 24 hours after LISA procedure
Mean number of attempts required
Time Frame: At time of LISA procedure
Procedure attempt defined as introduction of laryngoscope blade into the mouth
At time of LISA procedure
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
Time of medication infusion to completion of LISA procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Chiesi Farmaceutici S.p.A.

Investigators

  • Study Director: Venkatakrishna Kakkilaya, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2022

Primary Completion (Actual)

March 2, 2026

Study Completion (Actual)

March 2, 2026

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2021-0380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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