Dosing of Levetiracetam (Keppra) in Neonates
The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates|
- Pharmacokinetic profile [ Time Frame: 24 hours after dose ] [ Designated as safety issue: No ]3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose.
- Change in vital sign baseline [ Time Frame: 24 hours after loading dose ] [ 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 after dose ] [ 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:||September 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
|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|