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Age-Based Seizure Protocol for Pediatric Seizures (PediDOSE Trial)

Phase 3
Recruiting
Led By Manish I Shah, MD, MS
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between paramedic midazolam administration and hospital discharge, assessed up to 24 hours
Awards & highlights

Summary

This trial is designed to improve how paramedics treat seizures in children by making the midazolam dose age-based.

Who is the study for?
The PediDOSE trial is for children actively seizing when paramedics arrive, under their care, and transported by an EMS agency in the study. It excludes kids with known pregnancy, benzodiazepine allergy, or severe growth restriction as judged by the paramedic.Check my eligibility
What is being tested?
PediDOSE tests if age-based doses of midazolam given via muscle injection or nasal spray are more effective than current calculation-based methods at stopping seizures before reaching the hospital. The study changes protocols across 20 cities to compare outcomes.See study design
What are the potential side effects?
Potential side effects may include difficulty breathing if too much midazolam is administered. However, standardized doses used in this trial have been safely applied in other healthcare settings for children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between paramedic arrival on scene until 30 minutes after emergency department arrival
This trial's timeline: 3 weeks for screening, Varies for treatment, and between paramedic arrival on scene until 30 minutes after emergency department arrival for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Seizing on emergency department arrival
Secondary outcome measures
Respiratory failure
Time to first midazolam administration
Other outcome measures
Depressed level of consciousness
Dose/route adherence
Life-threatening cardiac arrhythmia
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
This arm will be exposed to the study intervention: a standardized seizure protocol.
Group II: ControlActive Control1 Intervention
This arm will be exposed to the emergency medical services (EMS) agency's existing seizure protocol; this is the control arm

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,411 Previous Clinical Trials
17,456,939 Total Patients Enrolled
7 Trials studying Seizures
5,358 Patients Enrolled for Seizures
Baylor College of MedicineOTHER
1,006 Previous Clinical Trials
5,997,308 Total Patients Enrolled
3 Trials studying Seizures
777 Patients Enrolled for Seizures
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,349 Previous Clinical Trials
642,177 Total Patients Enrolled
38 Trials studying Seizures
9,535 Patients Enrolled for Seizures

Media Library

Conventional seizure protocol Clinical Trial Eligibility Overview. Trial Name: NCT05121324 — Phase 3
Conventional seizure protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05121324 — Phase 3
~3064 spots leftby Jul 2026
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