Status:
COMPLETED
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures
Lead Sponsor:
Richard H. Haas
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Seizures
Disorder of Fetus or Newborn
Eligibility:
All Genders
1-14 years
Phase:
PHASE1
PHASE2
Brief Summary
The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.
Detailed Description
In adults, drug clearance is less than half of the glomerular filtration rate and the drug half-life is 6-8 hours. Renal function in infants at birth is characterized by immature glomerular filtration...
Eligibility Criteria
Inclusion
- Newborns admitted to the UCSD, Children's Hospital or Sharp Mary Birch NICUs with seizures.
- Term infants (gestational age greater than or equal to 37 weeks.
- \> 2500 grams (max blood for study 6mL =3%).
- Postnatal age 14 days or less.
- Serum creatinine less than 1.2 at time of enrollment.
- Received loading dose of phenobarbital 20mg/kg.
- Are still experiencing either clinical or electroencephalographic seizures despite this therapy.
- For whom parental consent to participate in the study is obtained.
Exclusion
- Biochemical abnormality - hypoglycemia, hypocalcemia-that when treated result in seizure cessation.
- Severe hypoxic ischemic injury likely to result in imminent death
- The only significant exclusions that will be made in recruitment and enrollment will be the exclusion of infants who are judged by the attending neonatologist to be so critically ill that death is imminent and benefit from neonatal intensive care is very unlikely.
- No rule-based criteria, (using lab or clinical parameters) adequately capture the complete nature of this clinical assessment.
- In general any child receiving active treatment with head cooling will not be excluded.
- Mechanical ventilation and/or the use of inotropic agents to support blood pressure will not be exclusion criteria.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00884052
Start Date
April 1 2007
End Date
October 1 2011
Last Update
March 26 2020
Active Locations (1)
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1
University of California, San Diego Medical Center / Neonatal Intensive Care Unit (NICU)
San Diego, California, United States, 92103