Pediatric Out-of-Hospital Cardiac Arrest Resuscitation: Evaluation of IM Epinephrine (The PRIME Trial)
Who is this study for? Patients with pediatric out-of-hospital cardiac arrest resuscitation
What treatments are being studied? Epinephrine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
This is a pragmatic, two-arm, open-label, prospective stepped-wedge cluster quasi randomized control trial (SW-CRCT) looking to evaluate early intramuscular (IM) epinephrine in the management of pediatric out-of-hospital cardiac arrest (POHCA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 17
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Canada
Children's Hospital - London Health Sciences Centre
RECRUITING
London
Contact Information
Primary
Maysaa Assaf
maysaa.assaf@lhsc.on.ca
519-685-8500
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2029-01
Participants
Target number of participants: 284
Treatments
No_intervention: Standard of Care
All POHCA events will be handled per standard of care of epinephrine administration via intravenous or intraosseous (IV/IO) based on patient estimated weight.
Other: Intramuscular Epinephrine Dose
POHCA events will be handled per standard of care, however, first dose epinephrine administration will be via intramuscular (IM) autoinjector and/or pre-filled syringes. Dosing will be dependent on weight as follows:~* 3-\<5kg=0.3mg IM epinephrine~* 5-\<10kg=0.5mg IM epinephrine~* 10-\<20kg=1.0mg IM epinephrine~* 20-\<30kg=2.0mg IM epinephrine~* 30kg=3.0mg IM epinephrine
Authors
Related Therapeutic Areas
Sponsors
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's