RECRUITINGPhase 2Phase 3

POHCA Resuscitation: Evaluation of IM Epinephrine

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).

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrollment

284 participants

Sites

1 locations

Start Date

January 2024

Completion

January 2028

Pediatric Out-of-Hospital Cardiac ArrestEpinephrine Injection

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

284

participants

Sites

locations

Duration

5.0 years

total trial span

Rate

pts/month needed

Jan 2024Month 33 of 60Jan 2028

55% of trial timeline elapsed27 months to primary endpoint

At 1 sites, each site needs to enroll approximately 5.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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Primary Outcomes

Time to initial return of spontaneous circulation (ROSC)

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.

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

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.

Idrees Samina, Assaf Maysaa, Davis Matthew et al.Trials2026

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

RECRUITINGPhase 2Phase 3

POHCA Resuscitation: Evaluation of IM Epinephrine

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrollment

284 participants

Sites

1 locations

Start Date

January 2024

Completion

January 2028

Pediatric Out-of-Hospital Cardiac ArrestEpinephrine Injection

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

284

participants

Sites

locations

Duration

5.0 years

total trial span

Rate

pts/month needed

Jan 2024Month 33 of 60Jan 2028

55% of trial timeline elapsed27 months to primary endpoint

At 1 sites, each site needs to enroll approximately 5.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Time to initial return of spontaneous circulation (ROSC)

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.

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

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.

Idrees Samina, Assaf Maysaa, Davis Matthew et al.Trials2026

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

1 Day

Max Age

17 Years

Sex

all

Healthy Volunteers

View full 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.

POHCA Resuscitation: Evaluation of IM Epinephrine

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

POHCA Resuscitation: Evaluation of IM Epinephrine

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)