Dosing of Levetiracetam (Keppra) in Neonates

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

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