Dosing of Levetiracetam (Keppra) in Neonates

Cincinnati Children's Hospital Medical Center

Status and phase

Completed

Phase 2

Phase 1

Conditions

Seizures

Treatments

Drug: levetiracetam

Study type

Interventional

Funder types

Other

Identifiers

NCT01239212

101335

Details and patient eligibility

About

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.

Enrollment

7 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 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