The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preterm infants with seizures.
Study Type
OBSERVATIONAL
Enrollment
18
Patients will receive levetiracetam as needed for clinical and/or electrographic seizures. Need for levetiracetam will be determined by the clinical team and will NOT determined by the study protocol.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Pharmacokinetic profile
Blood specimens for quantitation of levetiracetam and its metabolite L057 will be obtained from an indwelling vascular catheter not used for study drug infusion or by heel stick in three different sampling schedules: Group 1 (n=6): at times 2-15 minutes after the end of infusion, 1-2 hours, and 12 hours post start of infusion Group 2 (n=6): at times 2-15 minutes after the end of infusion, 2-4 hours, and 18 hours post start of infusion Group 3 (n=6): at times 2-15 minutes after the end of infusion, 4-8 hours, and 20-24 hours post start of infusion
Time frame: 24 hours after dose
Change in vital sign baseline
Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.
Time frame: 24 hours
Number of participants with adverse events
Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.
Time frame: 24 hours
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