Pharmacokinetics of Levetiracetam (Keppra) in Neonates

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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 NICU at Cincinnati Children's Hospital or Good Samaritan 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