Efficacy of Intravenous Levetiracetam in Neonatal Seizures

• Status: Completed
• Trial end date: 2019-07-31
• Target enrollment: 0
• Participant gender: All

Summary

A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory.

Monitoring for seizure detection will be tested at five (5) US sites and one (1) international site using the internet.

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

Details

• Lead Sponsor: Richard H. Haas
• Collaborators: Auckland City Hospital; Food and Drug Administration (FDA); Loma Linda University; Rady Children's Hospital, San Diego; Sharp Mary Birch Hospital for Women & Newborns; Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA; UCSF Benioff Children's Hospital Oakland; UCSF Benioff Children's Hospital Oakland, Oakland, CA; University of California, San Diego
• Treatments: Etiracetam; Levetiracetam; Phenobarbital; Piracetam

Criteria

Inclusion Criteria:

1. Newborns admitted to any of the study sites with electrographic seizures seizures.

2. Term infants gestational age >36 weeks less than 2 weeks of age.

3. Greater than 2200 grams.

4. Infants for whom parental consent to participate in the study is obtained.

Exclusion Criteria:

1. Infants who are already receiving anticonvulsants

2. If serum creatinine is greater than 1.6mM

3. If seizures are due to correctable metabolic abnormalities (i.e. hypoglycaemia, hypocalcemia, hyponatremia)

4. Subjects in whom death seems imminent, as assessed by the neonatologist.