Pediatric Out-of-Hospital Cardiac ArrestPhase 2/3PRIMENCT05166343
POHCA Resuscitation: Evaluation of IM Epinephrine
A Phase 2/3 study testing Epinephrine Injection in people with Pediatric Out-of-Hospital Cardiac Arrest, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Pediatric Out-of-Hospital Cardiac Arrest
- What is being tested?
- Epinephrine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2024to Jan 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Children who experience OHCA due to an obvious traumatic event.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital - London Health Sciences Centre
London, Ontario, N6A 5W9
Janice Tijssen, MD MSc
About this study
Official title: Pediatric Out-of-Hospital Cardiac Arrest Resuscitation: Evaluation of IM Epinephrine (The PRIME Trial)
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).
Read the detailed description
IM epinephrine may provide a more efficient means of administering the initial epinephrine dose (versus IV/IO administration) to a child experiencing pediatric out of hospital cardiac arrest (POHCA) with no greater risk of harm. In so doing, this may improve the short- and long-term outcomes of these patients. There is an abundance of literature detailing the risk/benefit profile of IM epinephrine use in anaphylaxis; however, there is no human data on this topic as it relates to cardiac arrest. Important knowledge gaps include whether the use of IM epinephrine via autoinjector and/or pre-filled syringe leads to faster administration of the initial doses of epinephrine without delaying time to definitive epinephrine (via IV/IO) and the impact on time to initial and sustained return of spontaneous circulation (ROSC). This trial will be the first to examine the role of IM epinephrine via autoinjector/pre-filled syringe in POHCA.
- Conditions
- Pediatric Out-of-Hospital Cardiac Arrest
- Being tested
- Epinephrine Injection
- Keywords
- cardiac arrest, IM Epinephrine, standard of care, pediatric, resuscitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine InjectionDrug
Epinephrine administered via sterile epinephrine injection USP, by 0.3mg or 0.5mg epinephrine auto-injector(s) and/or pre-filled syringe (exact dose).
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | All POHCA events will be handled per standard of care of epinephrine administration via intravenous or intraosseous (IV/IO) based on patient estimated weight. |
| Intramuscular Epinephrine Dose | Other | 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 Receives: Drug: Epinephrine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to initial return of spontaneous circulation (ROSC)
The primary outcome will be the time to initial ROSC. The investigator will compare time to initial ROSC between the standard of care and intervention periods.
Measured: At time of event
Secondary outcomes (10)
Return of spontaneous circulation
Whether return of spontaneous circulation is achieved or not
Measured: At time of event
Time to sustained ROSC
Time to sustained ROSC will be calculated from the time that paramedics arrive on scene to the time that sustained ROSC, defined as chest compressions not required for 20 minutes with persistent signs of circulation, is achieved.
Measured: At time of event
Survival
Survival to emergency department transfer to pediatric critical care unit (PCCU), if applicable: admitted to PCCU from external ED
Measured: From time of event to ED admission
Survival - comparison between both arms
Survival to hospital admission will be compared between standard of care and intervention periods
Measured: From time of event to hospital admission
PCCU/Hospital length of stay
PCCU and hospital length of stay will be calculated from time of admission to the PCCU/hospital and time to discharge from PCCU/hospital, if applicable, between standard of care and intervention periods
Measured: From time of hospital/PCCU admission to discharge, up to 1 year
Survival to hospital discharge
Survival to hospital discharge will be compared between standard of care and intervention periods
Measured: Dependent on course of hospital stay, up to 1 year
Post POHCA survival
Survival at 6 months and 12 months post-POHCA will be compared between standard of care and intervention periods
Measured: Dependent on survival at 6 and 12 month period post POHCA event
Neurological status
The investigator will compare PCPC scores at discharge, 6- and 12-months post-POHCA between the standard of care and intervention periods
Measured: From time of discharge and 6 and 12 months post POHCA event
Life Impact and Pediatric Quality of Life assessments
Life Impact assessment between 6 and 12 months: the investigator will use the Pediatric Quality of Life (PEDSQoL, Pediatrics Quality of Life) assessment tool at 6- and 12-months post-POHCA in all survivors and compare between standard of care and intervention periods. The score ranges from 0-100, with higher scores indicating better outcome.
Measured: 6 and 12 months post POHCA event
Life Impact and Pediatric Quality of Life assessments
Life Impact assessment between 6 and 12 months: the investigator will use the Daily Activities Scale at 6- and 12-months post-POHCA in all survivors and compare between standard of care and intervention periods. This scale is a subscore of the PEDSQoL tool with scores ranging from 0-100, with higher scores indicating better outcome.
Measured: 6 and 12 months post POHCA event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start8 Jan 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paramedic services across Ontario will participate in the study. All sites will begin with a period of baseline data collection (standard of care arm) and will cross over to the intervention arm (Intramuscular Epinephrine Dose arm) on a staggered schedule and in random order. Each site will remain in the intervention arm, once cross over happens, for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janice Tijssen, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Janice Tijssen, MD MSc, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166343
- Sponsor's protocol ID
- PRIME-1
- Acronym
- PRIME
- Status last verified
- Mar 2025
- First submitted
- 22 Nov 2021
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Idrees S, Assaf M, Davis M, Garcia-Bournissen F, Loosley J, Miller MR, Tijssen JA. Evaluating intramuscular epinephrine in pediatric out-of-hospital cardiac arrest (the PRIME trial): study protocol for a multi-centre, stepped-wedge cluster quasi-randomized controlled trial. Trials. 2026 Jun 8. doi: 10.1186/s13063-026-09776-3. Online ahead of print.
PubMed 42260675
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Out-of-Hospital Cardiac Arrest Resuscitation: Evaluation of IM Epinephrine (The PRIME Trial)
- ClinicalTrials.gov ID
- NCT05166343
- Acronym / sponsor ID
- PRIME / PRIME-1
- Conditions
- Pediatric Out-of-Hospital Cardiac Arrest
- Keywords
- cardiac arrest, IM Epinephrine, standard of care, pediatric, resuscitation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
IM epinephrine may provide a more efficient means of administering the initial epinephrine dose (versus IV/IO administration) to a child experiencing pediatric out of hospital cardiac arrest (POHCA) with no greater risk of harm. In so doing, this may improve the short- and long-term outcomes of these patients. There is an abundance of literature detailing the risk/benefit profile of IM epinephrine use in anaphylaxis; however, there is no human data on this topic as it relates to cardiac arrest. Important knowledge gaps include whether the use of IM epinephrine via autoinjector and/or pre-filled syringe leads to faster administration of the initial doses of epinephrine without delaying time to definitive epinephrine (via IV/IO) and the impact on time to initial and sustained return of spontaneous circulation (ROSC). This trial will be the first to examine the role of IM epinephrine via autoinjector/pre-filled syringe in POHCA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Paramedic services across Ontario will participate in the study. All sites will begin with a period of baseline data collection (standard of care arm) and will cross over to the intervention arm (Intramuscular Epinephrine Dose arm) on a staggered schedule and in random order. Each site will remain in the intervention arm, once cross over happens, for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –All POHCA events will be handled per standard of care of epinephrine administration via intravenous or intraosseous (IV/IO) based on patient estimated weight. |
| Intramuscular Epinephrine Dose | Other | Drug: Epinephrine InjectionPOHCA 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 |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Children who experience OHCA due to an obvious traumatic event.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinephrine InjectionEpinephrine administered via sterile epinephrine injection USP, by 0.3mg or 0.5mg epinephrine auto-injector(s) and/or pre-filled syringe (exact dose). | Drug | Intramuscular Epinephrine Dose |
Primary outcome
Time to initial return of spontaneous circulation (ROSC)
Time frame: At time of event
The primary outcome will be the time to initial ROSC. The investigator will compare time to initial ROSC between the standard of care and intervention periods.
10 secondary outcomes
Return of spontaneous circulation
Time frame: At time of event
Time to sustained ROSC
Time frame: At time of event
Survival
Time frame: From time of event to ED admission
Survival - comparison between both arms
Time frame: From time of event to hospital admission
PCCU/Hospital length of stay
Time frame: From time of hospital/PCCU admission to discharge, up to 1 year
Survival to hospital discharge
Time frame: Dependent on course of hospital stay, up to 1 year
Post POHCA survival
Time frame: Dependent on survival at 6 and 12 month period post POHCA event
Neurological status
Time frame: From time of discharge and 6 and 12 months post POHCA event
Life Impact and Pediatric Quality of Life assessments
Time frame: 6 and 12 months post POHCA event
Life Impact and Pediatric Quality of Life assessments
Time frame: 6 and 12 months post POHCA event
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 42260675Idrees S, Assaf M, Davis M, Garcia-Bournissen F, Loosley J, Miller MR, Tijssen JA. Evaluating intramuscular epinephrine in pediatric out-of-hospital cardiac arrest (the PRIME trial): study protocol for a multi-centre, stepped-wedge cluster quasi-randomized controlled trial. Trials. 2026 Jun 8. doi: 10.1186/s13063-026-09776-3. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Pediatric Out-of-Hospital Cardiac Arrest
Recruiting
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janice Tijssen, MD MSc principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Epinephrine Injection in people with Pediatric Out-of-Hospital Cardiac Arrest, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maysaa Assaf (519-685-8500 ext. 75548, maysaa.assaf@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to initial return of spontaneous circulation (ROSC) (time frame: At time of event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05166343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.