Pharmacokinetics of Levetiracetam (Keppra) in Neonates
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|ClinicalTrials.gov Identifier: NCT01261416|
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : December 16, 2010
|Condition or disease||Intervention/treatment|
|Seizures Epilepsy||Drug: levetiracetam|
|Study Type :||Observational|
|Actual Enrollment :||18 participants|
|Official Title:||Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
|Infants with seizures||
Patients will receive levetiracetam as needed for clinical and/or electrographic seizures. Need for levetiracetam will be determined by the clinical team and will NOT determined by the study protocol.
- Pharmacokinetic profile [ Time Frame: 24 hours after dose ]
Blood specimens for quantitation of levetiracetam and its metabolite L057 will be obtained from an indwelling vascular catheter not used for study drug infusion or by heel stick in three different sampling schedules:
Group 1 (n=6): at times 2-15 minutes after the end of infusion, 1-2 hours, and 12 hours post start of infusion Group 2 (n=6): at times 2-15 minutes after the end of infusion, 2-4 hours, and 18 hours post start of infusion Group 3 (n=6): at times 2-15 minutes after the end of infusion, 4-8 hours, and 20-24 hours post start of infusion
- Change in vital sign baseline [ Time Frame: 24 hours ]Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.
- Number of participants with adverse events [ Time Frame: 24 hours ]Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261416
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Stephanie Merhar, MD||Children's Hospital Medical Center, Cincinnati|