CHaMP node receives NINDS funding for prehospital study
- Published June 30, 2021
The Charlotte, Houston, and Milwaukee Prehospital (CHaMP) node—the prehospital-focused research node within the Pediatric Emergency Care Applied Research Network (PECARN)—is excited to announce that the National Institute of Neurological Disorders and Stroke (NINDS) is funding $10.5 million to the five-year “Pediatric Dose Optimization for Seizures in EMS (PediDOSE)” study. Manish Shah, MD, MS, a pediatric emergency medicine physician and emergency medical services (EMS) researcher at Baylor College of Medicine and Texas Children’s Hospital, is the principal investigator.
This 20-site research study will compare the effectiveness and safety of implementing standardized, calculation-free, age-based doses of paramedic-administered midazolam given via the intramuscular or intranasal routes to current EMS treatment of seizures. Actively seizing 6-month to 13-year-old patients will be enrolled if transported by paramedics from participating EMS agencies to emergency departments (ED) involved in this study.
Why is PediDOSE necessary?
- Seizures are one of the most common reasons why people call 911 for children
- Seizures that do not stop on their own can cause respiratory failure, brain damage, and death
- Midazolam, the proven treatment that paramedics already use to treat seizures, is often under-dosed in the EMS setting
- Delays in administering midazolam occur when paramedics place intravenous lines, prioritize checking blood glucose before medication administration, and when they do dose calculations
- One-third of actively seizing children arrive at EDs still seizing
- Optimizing how paramedics manage pediatric seizures by eliminating calculations and prioritizing medication delivery via rapid IN and IM routes has the potential to improve patient outcomes
Participating EMS agencies have agreed to be randomly assigned to when they will implement the new seizure protocol. Since a child experiencing an ongoing seizure is having a life-threatening emergency that must be promptly treated, it is not practical to obtain permission from parents about study enrollment before treatment is given. This means that eligible children will be enrolled under an accepted exception from informed consent process that follows federal rules for emergency research and will be approved by a research ethics review board. If age-based dosing is found to be both safe and effective, the potential impact of this study is a paradigm shift in the treatment of pediatric seizures that can be easily implemented in EMS systems across the country.
PECARN is the clinical research arm of the Emergency Medical Services for Children program. For more information, visit the CHaMP node’s webpage.