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

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Atropine and Fentanyl Premedication Arm
IV Normal Saline Placebo Arm
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn focused on measuring 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

Eligibility Criteria

0 Hours - 72 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkland Health and Hospital SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IV Atropine and Fentanyl Premedication Arm

IV Normal Saline Placebo Arm

Arm Description

Participants will receive premedication regimen of 20 micrograms/kilogram intravenous atropine and 0.5 micrograms/kilogram intravenous fentanyl prior to performance of LISA.

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.

Outcomes

Primary Outcome Measures

Number of bradycardia and hypoxemia events during 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 Outcome Measures

Percent of time spent with cerebral Near Infrared Spectroscopy (NIRS) values <55%
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
Procedure first attempt success rate
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.
Intubation rate
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.
Mean number of attempts required
Procedure attempt defined as introduction of laryngoscope blade into the mouth
Mean duration of bradycardia and hypoxemia events
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

Full Information

First Posted
September 13, 2021
Last Updated
August 17, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05065424
Brief Title
Premedication for Less Invasive Surfactant Administration Study (PRELISA)
Acronym
PRELISA
Official Title
Use of Premedication for Less Invasive Surfactant Administration: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Chiesi Farmaceutici S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IV Atropine and Fentanyl Premedication Arm
Arm Type
Experimental
Arm Description
Participants will receive premedication regimen of 20 micrograms/kilogram intravenous atropine and 0.5 micrograms/kilogram intravenous fentanyl prior to performance of LISA.
Arm Title
IV Normal Saline Placebo Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IV Atropine and Fentanyl Premedication Arm
Other Intervention Name(s)
IV Atropine sulfate and IV Fentanyl citrate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
IV Normal Saline Placebo Arm
Intervention Description
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 Outcome Measure Information:
Title
Number of bradycardia and hypoxemia events during LISA procedure
Description
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 Frame
Time of medication infusion to completion of LISA procedure
Secondary Outcome Measure Information:
Title
Percent of time spent with cerebral Near Infrared Spectroscopy (NIRS) values <55%
Description
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
Time Frame
From time of start of LISA procedure to 12 hours after procedure
Title
Procedure first attempt success rate
Description
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.
Time Frame
At time of LISA procedure
Title
Intubation rate
Description
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.
Time Frame
Within 24 hours after LISA procedure
Title
Mean number of attempts required
Description
Procedure attempt defined as introduction of laryngoscope blade into the mouth
Time Frame
At time of LISA procedure
Title
Mean duration of bradycardia and hypoxemia events
Description
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 Frame
Time of medication infusion to completion of LISA procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharmistha Saha, MD
Organizational Affiliation
Fellow Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharmistha Saha, MD
Phone
214-344-0317
Email
sharmistha.saha@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Venkat Kakkilaya, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Premedication for Less Invasive Surfactant Administration Study (PRELISA)

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