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NCT05121324 · ClinicalTrials.gov registry record · Phase 3
Pediatric Dose Optimization for Seizures in Emergency Medical Services
A Phase 3 study of Seizures, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 6,700
- Enrollment target
- 20
- Study locations
NCT05121324: Recruiting Phase 3 study of Seizures, sponsored by Stanford University.
NCT05121324 is a Phase 3 study of Seizures that is actively recruiting participants, run by Stanford University. The registered enrollment target is 6,700 participants, above the 763-participant average among 39 other Seizures trials with a reported enrollment target (778% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05121324, a Phase 3 study of Seizures, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 6,700 participants
- Enrollment target
- 20
- Study locations
Study 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 jus
Primary Outcome
Binary assessment of whether the participant is seizing or not upon arrival to the emergency department, as measured by either a rapid response electroencephalogram (preferred) or clinical judgement (alternative).
Conditions Studied
Interventions
- DRUG Standardized seizure protocol
- DRUG Conventional seizure protocol
Study Locations (20)
California
- Children's Hospital of Los Angeles - Los Angeles
- University of California, Davis - Sacramento
- University of California, San Francisco - San Francisco
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Texas
- University of Texas Southwestern - Dallas
- Baylor College of Medicine - Houston
Arizona
- University of Arizona - Tucson
Colorado
- University of Colorado - Aurora
District of Columbia
- Children's National Hospital - Washington D.C.
Georgia
- Emory University - Atlanta
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,700 participants |
| Start Date | 2022-08-08 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
What NCT05121324 shows while recruiting
NCT05121324 is an interventional study that assigns participants to a tested intervention. Its 6,700 participants enrollment target places it among the larger protocols in the corpus, above the 763-participant average among 39 other Seizures trials with a reported enrollment target (778% higher).
The record links to 1 condition, with Seizures appearing as the primary indexed condition, and to 2 interventions - of which Standardized seizure protocol is the first listed.
NCT05121324 names 20 study sites across 16 states, led by California, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT05121324 about?
NCT05121324 is a clinical study titled "Pediatric Dose Optimization for Seizures in Emergency Medical Services". 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 midazo...
What is the current status of trial NCT05121324?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 6,700 participants. The study started on 2022-08-08. Estimated completion is 2026-09-30.
What conditions does trial NCT05121324 study?
This clinical trial studies the following conditions: Seizures.
What interventions are being tested in trial NCT05121324?
The interventions under investigation include: Standardized seizure protocol (DRUG), Conventional seizure protocol (DRUG).
Who is sponsoring clinical trial NCT05121324?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05121324 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05121324's enrollment target sits among peer trials
6,700 2nd of 39 the highest of 39 other Seizures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Seizures trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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