Overview

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
Collaborator:
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.