Evaluating IM Epinephrine for Pediatric Cardiac Arrest
Pediatric Out-of-Hospital Cardiac Arrest Resuscitation: Evaluation of IM Epinephrine (The PRIME Trial)
This study is testing if giving epinephrine through a shot in the muscle can help children who have a cardiac arrest outside of the hospital recover faster and have better outcomes compared to the usual methods.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 284 (estimated) |
| Ages | 1 Day to 17 Years |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT05166343 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the use of intramuscular (IM) epinephrine in children experiencing out-of-hospital cardiac arrest (POHCA) through a pragmatic, two-arm, open-label design. It aims to determine if IM administration can provide a quicker and safer initial dose of epinephrine compared to traditional intravenous or intraosseous methods. The study will assess the impact of IM epinephrine on the time to return of spontaneous circulation (ROSC) and overall patient outcomes. This is the first trial to investigate the use of IM epinephrine specifically in the context of pediatric cardiac arrest.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 day to 17 years who are experiencing an out-of-hospital cardiac arrest and have received CPR from trained responders.
Not a fit: Patients who have suffered cardiac arrest due to obvious traumatic events will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and outcomes for children experiencing cardiac arrest outside of a hospital setting.
How similar studies have performed: While there is extensive literature on IM epinephrine use in other contexts, this specific application in pediatric cardiac arrest is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 1 day to and including 17 years experiencing an out-of-hospital cardiac arrest (OHCA) * Must be receiving at least 1 minute of CPR by trained first responders (police, fire, or paramedic services) Exclusion Criteria: \- Children who experience OHCA due to an obvious traumatic event.
Where this trial is running
London, Ontario
- Children's Hospital - London Health Sciences Centre — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Janice Tijssen, MD MSc — London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study coordinator: Maysaa Assaf
- Email: maysaa.assaf@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.