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Premedication for Neonatal Respiratory Distress Syndrome (PRELISA Trial)
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.
PRELISA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPRELISA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PRELISA Trial Design
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Who is running the clinical trial?
Media Library
- My baby is on CPAP for breathing support and qualifies for the LISA procedure.My infant has severe birth defects, including heart, airway, or brain issues.Babies born to mothers who are addicted to opioids or are in a methadone treatment program.My infant needed a breathing tube before receiving surfactant treatment.
- Group 1: IV Normal Saline Placebo Arm
- Group 2: IV Atropine and Fentanyl Premedication Arm
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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