Clinical trial Recruiting at 20 sites Phase 3 Interventional Ages 6 Months to 13

Optimizing seizure treatment for children in ambulances

Official title: Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

Run by Stanford University · NCT05121324 · Data updated 2026-11-12

This study is testing a new way for paramedics to treat seizures in children during ambulance rides to see if it works better than the usual methods.

Quick facts

PhasePhase 3
Study typeInterventional
Ages6 Months to 13 Years
SexAll
Enrollment6700 (estimated)
SponsorStanford University
Academic / other
Locations20 sites (Tucson, Arizona and 19 other locations)
StatusRecruiting
StartedAugust 8, 2022
Main results expectedJuly 31, 2026
Study endsSeptember 30, 2026
Registry record updatedSeptember 30, 2025
Trial IDNCT05121324 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include children actively seizing who are under the care of paramedics and being transported by participating EMS agencies.

Probably not a fit

Patients with a history of benzodiazepine allergy, known or presumed pregnancy, or severe growth restriction may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study aims to enhance the treatment of seizures in children by paramedics during ambulance transport. It addresses the common issue of under-dosing and delayed medication delivery, which can lead to continued seizures upon arrival at emergency departments. The study compares a standardized seizure protocol using muscular injection or nasal spray against conventional methods to determine effectiveness and safety in pediatric patients. This research is crucial as most existing studies have focused on adults, highlighting the need for tailored approaches for children.

Why it matters

Potential benefit: If successful, this study could significantly improve seizure management in children during emergency situations, leading to better outcomes.

How similar studies have gone: While similar approaches have been tested in adults, this study represents a novel effort to optimize seizure treatment specifically for pediatric patients.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Witnessed by the paramedic to be actively seizing, regardless of seizure type or duration; AND
* Under the care of a paramedic; AND
* Transported by an EMS agency participating in the study

Exclusion Criteria:

* A prior history of a benzodiazepine allergy; OR
* Known or presumed pregnancy; OR
* Severe growth restriction based on the paramedic's subjective assessment

Where it's running

  • University of Arizona
    Tucson, Arizona, United States
    Recruiting
  • Children's Hospital of Los Angeles
    Los Angeles, California, United States
    Recruiting
  • University of California, Davis
    Sacramento, California, United States
    Recruiting
  • University of California, San Francisco
    San Francisco, California, United States
    Recruiting
  • University of Colorado
    Aurora, Colorado, United States
    Recruiting
  • Children's National Hospital
    Washington D.C., District of Columbia, United States
    Recruiting
Show 14 more locations
  • Emory University
    Atlanta, Georgia, United States
    Recruiting
  • Indiana University
    Indianapolis, Indiana, United States
    Recruiting
  • University of Michigan
    Ann Arbor, Michigan, United States
    Recruiting
  • University at Buffalo
    Buffalo, New York, United States
    Recruiting
  • Mecklenburg EMS
    Charlotte, North Carolina, United States
    Recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio, United States
    Recruiting
  • Nationwide Children's Hospital
    Columbus, Ohio, United States
    Recruiting
  • Oregon Health and Sciences University
    Portland, Oregon, United States
    Recruiting
  • University of Pittsburgh
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • University of Texas Southwestern
    Dallas, Texas, United States
    Recruiting
  • Baylor College of Medicine
    Houston, Texas, United States
    Recruiting
  • University of Utah
    Salt Lake City, Utah, United States
    Recruiting
  • University of Washington
    Seattle, Washington, United States
    Recruiting
  • Medical College of Wisconsin
    Milwaukee, Wisconsin, United States
    Recruiting

Study contacts

  • Principal investigator: Manish I Shah, MD, MS — Stanford University
  • Study coordinator: Manish I Shah, MD, MS
  • Email: mshah5@stanford.edu
  • Phone: 650-723-3319

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Levetiracetam to prevent seizures in adults with Down syndrome and Alzheimer's disease

    This trial will test whether the anti-seizure medicine levetiracetam can prevent tonic-clonic seizures and slow cognitive decline in adults over 40 who have Down syndrome and symptomatic Alzheimer's disease.

    Recruiting Phase 3 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Granada, Andalusia and 4 other locations · NCT07234695

  • Recognizing seizures in the intensive care unit

    This project tests how well NHS neurophysiology scientists, neurologists, intensivists, and ICU nurses can identify seizures from digital video recordings of ICU events.

    Recruiting Nottingham University Hospitals NHS Trust · Nottingham, Nottinghamshire · NCT07136298

  • Preventing first seizures with levetiracetam in patients with motor cortex brain metastases

    This test will try giving levetiracetam to adults with motor cortex brain metastases who have never had a seizure to see if it prevents a first seizure compared with not giving the drug.

    Recruiting Phase 2 Brigham and Women's Hospital · Boston, Massachusetts · NCT07130786

  • Preventing early seizures after traumatic brain injury

    This randomized study will test whether phenytoin, levetiracetam, or placebo best prevent early seizures in people hospitalized with moderate-to-severe traumatic brain injury.

    Recruiting at 3 sites Phase 4 All India Institute of Medical Sciences, Jodhpur · Chandigarh, Punjab and 2 other locations · NCT07072624

  • Wearable device for detecting seizures

    This study tests a new wearable device for detecting seizures in people with epilepsy to see if it works well and can help them feel more comfortable in their daily lives.

    Recruiting at 2 sites University of Massachusetts, Worcester · Worcester, Massachusetts and 1 other locations · NCT06598189

  • Registry for patients with thyroid hormone resistance

    This study is collecting information from patients with thyroid hormone resistance to see how their specific gene mutations affect their health and improve diagnosis and treatment.

    Recruiting Charite University, Berlin, Germany · Berlin · NCT06566066

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.