Neonatal Seizures Clinical Trial
Official title:
Safety, Tolerability, and Efficacy of Levetiracetam for Neonatal Seizures
The purpose of this research study is to learn how well the medication levetiracetam
(Keppra) works to treat seizures in full term and premature babies. Levetiracetam is
commonly used in babies with seizures at Cincinnati Children's Hospital, especially if the
seizures have not been stopped by other medicines. The Food and Drug Administration (FDA)
has approved the use of levetiracetam for older children (over the age of 4) but not for
infants. Even though it is not FDA approved for this age group, doctors at Cincinnati
Children's use the medicine as a second drug in babies whose seizures are not stopped by
phenobarbital. Some doctors are concerned that phenobarbital is not the best medicine to
treat seizures in babies, so researchers are trying to study other medicines.
In this study, the investigators are looking at how well levetiracetam stops or slows down
seizures in babies. The investigators are also studying the blood levels of levetiracetam to
learn more about how the medicine is processed by the body and what level of medicine in the
body works to stop seizures. The investigators are checking labs before and after giving the
dose to make sure the medication does not cause any changes in blood counts, kidney
function, or liver function. The investigators are following all of the babies in the study
after hospital discharge to see if the parents notice any side effects of the medication.
Babies in the study will come back to the High Risk Follow Up Clinic at Cincinnati
Children's at 6 months of age for a visit with a neurologist and a neonatologist and
developmental testing.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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||
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