Status:
COMPLETED
Pharmacokinetics of Levetiracetam (Keppra) in Neonates
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Seizures
Epilepsy
Eligibility:
All Genders
1-30 years
Brief 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 seizur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01261416
Start Date
October 1 2008
End Date
July 1 2010
Last Update
December 16 2010
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229