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Premedication for Neonatal Respiratory Distress Syndrome (PRELISA Trial)

Phase 4
Recruiting
Led By Sharmistha Saha, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours after lisa procedure
Awards & highlights

PRELISA Trial Summary

This trial will help determine if it is safe and more effective to give premedication to infants before they undergo the Less Invasive Surfactant Administration procedure.

Who is the study for?
The PRELISA trial is for preterm infants aged between 0-72 hours, at least 29 weeks gestational age, needing CPAP respiratory support and qualifying for the LISA procedure. It excludes those with severe congenital anomalies, born to mothers with opioid addiction or on methadone treatment, or requiring intubation before surfactant therapy.Check my eligibility
What is being tested?
This study tests if IV fentanyl and atropine given before the LISA procedure can reduce bradycardia and hypoxemia events in preterm infants compared to a placebo. The trial is double-blinded and randomized; success rates of the first attempt and effects on cerebral oxygenation are also measured.See study design
What are the potential side effects?
Potential side effects from IV fentanyl may include slowed breathing rate, low blood pressure, drowsiness or sedation. Atropine could cause dry mouth, blurred vision, sensitivity to light or an increased heart rate. Side effects will be closely monitored during the trial.

PRELISA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby is on CPAP for breathing support and qualifies for the LISA procedure.

PRELISA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of lisa procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of lisa procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interventional procedure
Secondary outcome measures
Intubation rate
Mean duration of bradycardia and hypoxemia events
Mean number of attempts required
+2 more

PRELISA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IV Atropine and Fentanyl Premedication ArmExperimental Treatment1 Intervention
Participants will receive premedication regimen of 20 micrograms/kilogram intravenous atropine and 0.5 micrograms/kilogram intravenous fentanyl prior to performance of LISA.
Group II: IV Normal Saline Placebo ArmPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,043 Previous Clinical Trials
1,053,492 Total Patients Enrolled
Chiesi Farmaceutici S.p.A.Industry Sponsor
198 Previous Clinical Trials
311,956 Total Patients Enrolled
Sharmistha Saha, MDPrincipal InvestigatorFellow Physician

Media Library

IV Atropine and Fentanyl (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05065424 — Phase 4
Neonatal Respiratory Distress Syndrome Research Study Groups: IV Normal Saline Placebo Arm, IV Atropine and Fentanyl Premedication Arm
Neonatal Respiratory Distress Syndrome Clinical Trial 2023: IV Atropine and Fentanyl Highlights & Side Effects. Trial Name: NCT05065424 — Phase 4
IV Atropine and Fentanyl (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05065424 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA accorded approval to IV Atropine and Fentanyl Premedication Arm?

"A score of 3 was assigned to the IV Atropine and Fentanyl Premedication Arm due to its approval status; this is a Phase 4 trial."

Answered by AI

Does my profile meet the prerequisites to be accepted into this experiment?

"This investigation requires 58 neonates between 0 and 72 hours of life with respiratory distress syndrome that meet the Parkland OPTISURF criteria for enrolment. The infants must also be ≥29 weeks gestational age, and currently under CPAP therapy to qualify."

Answered by AI

What precedent exists regarding the combination of IV Atropine and Fentanyl Premedication Arm?

"Currently, 63 clinical trials are evaluating the efficacy of IV Atropine and Fentanyl Premedication Arm. Of these active studies, 16 have reached Phase 3 status. The majority of these experiments take place in Rochester, Minnesota; however there are a total 225 sites across the world hosting research on this specific drug therapy."

Answered by AI

Is it still possible for participants to join this investigation?

"Data hosted on clinicaltrials.gov corroborates that this experiment is presently enlisting test subjects. This trial was initially broadcasted on March 14th 2022 and the details were last modified on March 26th 2022."

Answered by AI

Is participation in the study open to octogenarians?

"This study is seeking participants who are between 0 Hours and 72 hours old. There are 67 trials for minors and 164 studies that target adults aged 65 or older."

Answered by AI

What medical conditions can the IV Atropine and Fentanyl Premedication Arm provide relief for?

"Intravenous atropine and fentanyl premedication arm is normally prescribed for treating ureteric colic. It can also be beneficial in dealing with symptoms such as uncontrollable laughter, contraction of the pupils, or runny nose."

Answered by AI

What is the current capacity for participants in this clinical trial?

"Affirmative. The information hosted on clinicaltrials.gov establishes that this healthcare investigation, which was initially posted in March 14th 2022, is presently recruiting individuals for participation. Approximately 58 volunteers are needed from a single location."

Answered by AI
Recent research and studies
~2 spots leftby May 2024