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: 5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses) ] [ 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. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.
- 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)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239212
|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|