A new University of Michigan Health System study, Established Status Epilepticus Treatment Trial (ESETT), will compare three drugs that treat seizures in patients. The study aims to reduce brain damage and increase the likelihood of patient survival during prolonged and dangerous seizures. For years, doctors have tried different methods to stop severe seizures in adults and children. Now, they are testing fosphenytoin, levetiracetam and valproic acid to see which one will work best in emergency situations.
Status epilepticus is a type of epilepsy where the patient has seizures that last 30 minutes or more. Status epilepticus can also come in the form of clusters, or shorter seizures that happen for 30 minutes or more. Convulsive status epilepticus is characterized as a tonic-clonic seizure, which is the most traumatic type. The goal of the study is to treat these seizures, making them less severe.
Patients who experience tonic-clonic seizures first go through a loss of consciousness followed by a shriek. Then, the muscles of the arms, legs, chest and back become stiff. The face may become blue due to lack of oxygen. After one minute, the muscles begin to twitch and jerk. During these types of seizures, the patient can bite their tongue and become frothy or bloody at the mouth. If the seizure lasts more than five minutes, emergency help should be called right away.
Causes of Neonatal Seizures
- Hypoxic ischemic encephalopathy (HIE) – HIE is a lack of blood and oxygen flow to the brain. This brain injury leads to uncontrolled electricity in the brain, or seizures. Seizures from HIE are usually evident within the first 24 hours of life. Neonatal seizures may be one of the first signs that a child may have HIE. Hypothermia treatment (also known as brain or body cooling) is currently the most effective treatment for HIE. Read more
- Intracranial hemorrhages – This includes intraventricular, intracerebral, subdural and subarachnoid hemorrhages.
- Central nervous system infections – These include encephalitis, herpes encephalitis, meningitis and cytomegalovirus. Bacterial infections are treated with antibiotics. Herpes infections are treated with Acyclovir.
- Fetal or Neonatal Stroke – Stokes occur when the blood supply to the brain is blocked, restricted, or when there are hemorrhages or HIE. IV fluids and anti-clotting medication can prevent future strokes and hypothermia can help to prevent or reduce the damage from seizures.
- Metabolic problems – These include hypoglycemia and hypocalcemia. Hypoglycemia can be treated with a glucose solution IV and hypocalcemia can be treated with calcium gluconate or calcium chloride.
Treatment of Severe Seizures
While identifying the causes of seizures is important, it is also important to find a treatment that works. There are a number of treatments for less severe seizures. However, for severe seizures, the options are limited. That is why UM is testing the following medicine to reduce brain damage:
- Fosphenytoin – An approved medication to stop prolonged seizures in adults, but not FDA approved for children.
- Levetiracetam – A newer drug that is promising for babies who cannot tolerate phenobarbital. It is approved by the FDA to treat seizures, but not prolonged seizures.
- Valproic acid- An approved medication for seizures and mood disorders, but not approved to treat prolonged seizures.
For the study, patients will be randomly assigned to one of the drugs listed above. Each participant will be approved under Exception From Informed Consent (EFIC). Studies that are conducted in emergency situations do not need consent. Participants will be given medication according to their specific needs. A total of 795 people will be participating from around the country.
The National Institutes of Health, the Neurological Emergency Treatment Trials (NETT) and the Pediatric Emergency Care Applied Research Network all came together to make this study possible. Through this work, they aim to improve emergency care for severe injuries and illnesses of the brain, spinal cord and nervous system in adults and children.
Call Us About Your Potential Case
If your child suffers from seizures from any causes or if your child suffers from birth injury related conditions, call us to find out if you have a case. At Reiter and Walsh, PC, we have the experience and knowledge to help your child to get the care they need. For your free case review, please contact an attorney from our legal team. You may contact us in any of the following ways:
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