Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Richard H. Haas
• Collaborators: Pediatric Pharmacology Research Units Network; Thrasher Research Fund
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.