Pharmacokinetics of Levetiracetam (Keppra) in Neonates

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Seizures; Epilepsy

Treatments: Drug: levetiracetam

Study type: Observational

Funder types: Other

Identifiers

NCT01261416

101335-2

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 1 patient group

Infants with seizures

Treatment:

Drug: levetiracetam