Status:
TERMINATED
Efficacy of Keppra for Neonatal Seizures
Lead Sponsor:
Stephanie Merhar, MD
Conditions:
Neonatal Seizures
Eligibility:
All Genders
Up to 30 years
Brief Summary
The purpose of this research study is to learn how well the medication levetiracetam (Keppra) works to treat seizures in full term and premature babies. Levetiracetam is commonly used in babies with s...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Gestational age ≥ 35 weeks
- Postnatal age ≤ 30 days
- Birth weight ≥ 2000 grams
- Clinical or electrographic seizures of any etiology requiring treatment with an antiepileptic medication (as per the judgment of the clinician caring for the patient)
- Parental consent obtained
- Exclusion criteria:
- Infants with renal insufficiency indicated by serum creatinine \> 2.0 (as part of pre-screening, labs obtained as part of routine care will be reviewed. Infants who have not had a creatinine drawn will have one drawn as part of the study after consent is obtained. If the baby requires levetiracetam emergently before the results of the creatinine are back, the dose will still be given and levels will still be drawn as per the protocol.
- Infants who have previously received levetiracetam
- Parents refuse consent
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01475656
Start Date
November 1 2011
End Date
August 1 2012
Last Update
April 19 2013
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45215