Dosing of Levetiracetam (Keppra) in Neonates

Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm 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.

Inclusion Criteria:

• Gestational age ≥ 32 weeks
• Postnatal age ≤ 30 days
• Birth weight ≥ 2000 grams
• Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital
• Clinical or electrographic seizures of any etiology
• Seizures or seizure prophylaxis requiring treatment with levetiracetam
• Parental consent obtained

Exclusion Criteria:

• Infants with renal insufficiency indicated by serum creatinine > 2.0 at any time
• Infants who have previously received levetiracetam
• Parents refuse consent
• Attending physician does not wish the infant to be enrolled in the study
• Infants who are currently receiving an investigational drug