Pharmacokinetics of Levetiracetam (Keppra) in Neonates
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates|
- Pharmacokinetic profile [ Time Frame: 24 hours after dose ] [ Designated as safety issue: No ]
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
- Change in vital sign baseline [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.
- Number of participants with adverse events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.
|Study Start Date:||October 2008|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|Infants with seizures||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261416
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Stephanie Merhar, MD||Children's Hospital Medical Center, Cincinnati|