SUSPENDED

Premedication for Less Invasive Surfactant Administration Study (PRELISA)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-06
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT05065424

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.

Ages Eligible for Study:0 Hours to 72 Hours
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Infants ≥29 weeks gestational age initiated on CPAP in the delivery room or upon admission who require ≥0.25 FiO2.
  1. * Infants requiring intubation prior to surfactant therapy
  2. * Infants with known severe congenital anomalies (including complex congenital heart disease, airway, and central nervous system anomalies)
  3. * Infants born to mothers with known opioid addiction or in a methadone treatment program
  4. * Maternal COVID19 infection (RT-PCR positive) within two weeks prior to delivery

Contacts and Locations

Principal Investigator

Venkatakrishna Kakkilaya, MD
STUDY_DIRECTOR
UT Southwestern Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Venkatakrishna Kakkilaya, MD, STUDY_DIRECTOR, UT Southwestern Medical Center

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 Registration Dates

Study Start Date2022-04-06
Study Completion Date2025-11

Study Record Updates

Study Start Date2022-04-06
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Respiratory Distress Syndrome, Newborn