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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

PediDOSE Trial 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.

PediDOSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between paramedic arrival on scene until 30 minutes after emergency department arrival

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

PediDOSE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,335,350 Total Patients Enrolled

7 Trials studying Seizures

5,358 Patients Enrolled for Seizures

Baylor College of MedicineOTHER

1,001 Previous Clinical Trials

5,996,412 Total Patients Enrolled

3 Trials studying Seizures

777 Patients Enrolled for Seizures

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,341 Previous Clinical Trials

643,589 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom is this experiment an appropriate fit?

"4840 patients that suffer from seizures and are between 6 months to 13 years old can participate in this trial. The most important criteria for applicants are as follows: they must be transported by an EMS agency participating in the study, have their seizure(s) witnessed by a paramedic, and be under the care of a paramedic during the event."

Answered by AI

What health issues does the Standardized seizure protocol typically address?

"The standardized protocol for seizure treatment is also useful in cases of amnesia, status epilepticus (convulsive), and anxiolytic therapy."

Answered by AI

The age limit for participants in this experiment is ____ years old.

"In order to participate in this trial, patients must be between 6 months and 13 years old. Out of the total number of clinical trials, 62 are for people under 18 and 101 are for those over 65."

Answered by AI

In how many medical facilities is this research being conducted?

"With 20 different locations currently recruiting, this clinical trial is widely accessible. Some of the recruited sites include University of Colorado in Aurora, University of Arizona in Tucson, and University at Buffalo in Buffalo."

Answered by AI

Are there other experiments that use a similar seizure control method?

"There are currently 68 ongoing studies researching Standardized seizure protocol. Of those, 10 are in Phase 3. The many studies for Standardized seizure protocol are based primarily in Porto Alegre, California, but there are 699 locations running trials worldwide."

Answered by AI

Are volunteers currently being accepted for this research project?

"This trial is not presently looking for new enrollees. The listing was originally posted on May 1st, 2022 but the most recent update to the posting occurred on November 4th, 2021. If you are seeking out other studies, there are 86 trials concerning seizures and 68 Standardized seizure protocol clinical trials that are currently recruiting patients."

Answered by AI

How many people are being recruited for this clinical study?

"Unfortunately, this particular clinical trial is no longer looking for patients as of their last update on November 4th, 2021. According to our records, 86 other trials regarding seizures and 68 Standardized seizure protocol studies are currently seeking patients."

Answered by AI