NCT05121324 Pediatric Dose Optimization for Seizures in Emergency Medical Services
| NCT ID | NCT05121324 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Stanford University |
| Condition | Seizures |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,700 participants |
| Start Date | 2022-08-08 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 6,700 participants in total. It began in 2022-08-08 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children. PediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner. One aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice. Another aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings. If this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world.
Eligibility 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
Contact & Investigator
Manish I Shah, MD, MS
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT05121324 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 13 Years, studying Seizures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05121324 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 6,700 participants.
Is NCT05121324 currently recruiting?
Yes, NCT05121324 is actively recruiting participants. Contact the research team at mshah5@stanford.edu for enrollment information.
Where is the NCT05121324 trial being conducted?
This trial is being conducted at Tucson, United States, Los Angeles, United States, Sacramento, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT05121324 clinical trial?
NCT05121324 is sponsored by Stanford University. The principal investigator is Manish I Shah, MD, MS at Stanford University. The trial plans to enroll 6,700 participants.