RECRUITING

Pediatric Dose Optimization for Seizures in Emergency Medical Services

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

Quick Facts

Study Start:2022-08-08
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05121324

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 13 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Witnessed by the paramedic to be actively seizing, regardless of seizure type or duration; AND
  2. * Under the care of a paramedic; AND
  3. * Transported by an EMS agency participating in the study
  1. * A prior history of a benzodiazepine allergy; OR
  2. * Known or presumed pregnancy; OR
  3. * Severe growth restriction based on the paramedic's subjective assessment

Contacts and Locations

Study Contact

Manish I Shah, MD, MS
CONTACT
650-723-3319
mshah5@stanford.edu
Leonard Basobas, MS
CONTACT
773-504-5963
lbasobas@stanford.edu

Principal Investigator

Manish I Shah, MD, MS
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 85724
United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027
United States
University of California, Davis
Sacramento, California, 95817
United States
University of California, San Francisco
San Francisco, California, 94143
United States
University of Colorado
Aurora, Colorado, 80045
United States
Children's National Hospital
Washington, District of Columbia, 20010
United States
Emory University
Atlanta, Georgia, 30322
United States
Indiana University
Indianapolis, Indiana, 46202
United States
University of Michigan
Ann Arbor, Michigan, 48105
United States
University at Buffalo
Buffalo, New York, 14203
United States
Mecklenburg EMS
Charlotte, North Carolina, 28226
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Oregon Health and Sciences University
Portland, Oregon, 97239
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
University of Texas Southwestern
Dallas, Texas, 75235
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84108
United States
University of Washington
Seattle, Washington, 98104
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Manish I Shah, MD, MS, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-08
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2022-08-08
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Child
  • Emergency Medical Services

Additional Relevant MeSH Terms

  • Seizures