UB researchers will spend next few months educating local families of children with seizure disorders about this unique study
By the University at Buffalo
Few things are more frightening for a parent than seeing their child experience a seizure. For the parent and for the paramedics who arrive on the scene, the primary goal is to stop the child’s seizure.
Now, University at Buffalo researchers are leading a project designed to determine how to achieve that more quickly, even when on the way to the hospital.
Brooke Lerner, Ph.D., and Brian Clemency, D.O., professors of emergency medicine in the Jacobs School of Medicine and Biomedical Sciences at UB, are co-principal investigators on a new study of age-based dosing of seizure medications in the prehospital setting. Both researchers also practice at UBMD Emergency Medicine.
The Pediatric Dose Optimization for Seizures in Emergency Medical Services study, or PediDOSE, which is being conducted in 20 cities, is funded by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health.
“The longer the seizure goes on, the more negative outcomes the child may experience,” Lerner says. “Our preliminary work showed that children experiencing a seizure outside of a hospital often do not receive enough medication to effectively stop the seizure.”
Determining Proper Dose
“The aim of this study is to evaluate an easier-to-use method for determining proper medication dose for a seizing child,” Lerner continues. “This method does not require calculations and can be done more quickly. We believe it will be more likely to stop the seizure before a child reaches the emergency department.
“This study has the power to change emergency practice in ambulances across the country,” he says.
Lerner and Clemency are pioneering Buffalo’s efforts to help these seizure patients. They are working with 20 other EMS systems serving sites in the Pediatric Emergency Care Research Network (PECARN) across the country; and with American Medical Response, an emergency medical services company that operates in Western New York.
“Currently, one-third of actively seizing children are still seizing by the time they reach the emergency department,” Lerner says. “This may be due to an inadequate dosage or delay in administering medication, so it fails to stop the seizure.”
Lerner, along with the other principal investigators in this project, hypothesize that underdosing of medications may be attributed to the practice of calculating the dosage based on the child’s weight. Instead, they believe that standardized age-based dosing may be a more effective and efficient way to treat patients. This method eliminates the multistep calculations of weight-based dosing.
“We found that maybe we don't need to be calculating the dose based on weight, especially since the child or whomever they are with may not know their weight and it can be hard to guess it,” Lerner says. “But, most people who are with the child will know the child’s age.”
A New Protocol
The study requires a change in protocol and practice. Usually, the participant’s informed consent must be obtained before any intervention can occur, including the administration of medication. Informed consent in a research study involves a detailed consent form, which the participant can study and discuss with their own provider if they wish before deciding whether to give consent.
However, in emergency situations, that isn’t feasible due to the speed with which medication must be delivered and the environment, which may be the ambulance or the emergency department. Therefore, federal regulations allow for investigators to conduct this study using an exception from informed consent in emergency research. These regulations allow individuals to be enrolled in the study without consent as long as the community is notified of the study and given the opportunity to provide feedback, and enrolled individuals are notified of their participation as soon as it is feasible.
“Children can’t consent to participate in the study because they are not of legal age,” Lerner says. “Even with an adult present, having your child seize is not a moment when you can make an informed decision about research.”
For these reasons, Lerner explains, the research team will spend the next several months focused on educating the Buffalo community about this study and who it will benefit.
“Our plan includes conducting educational interviews with parents who arrive at the Oishei Children’s Hospital emergency department, collaborating with the Epilepsy Society, and other organizations of affected families, and posting advertisements and educational materials through the media and other patient networks,” Lerner says.
Community members can participate in a survey designed to gather feedback on how the community views the planned study procedures. To participate in this survey or to learn more about the study, visit https://redcap.utahdcc.org/redcap/surveys/?s=HPHKPDJM39, or contact the research team at 716-222-0561.
The study, which begins in May, will collect data over the next four years.
"This study has the potential to have a very big impact on prehospital care across the country,” Lerner says. “Our primary goal is to ultimately improve pediatric prehospital seizure care.”
In addition to Lerner and Clemency, other UB faculty involved in the study include Michelle Penque, M.D., clinical associate professor of pediatrics; Arie Weinstock, M.D., professor of clinical neurology; and Bree Kramer, D.O., clinical associate professor of pediatrics, all of the Jacobs School.