Status:
COMPLETED
Dosing of Levetiracetam (Keppra) in Neonates
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Seizures
Eligibility:
All Genders
1-30 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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 :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01239212
Start Date
September 1 2010
End Date
July 1 2011
Last Update
September 5 2021
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229