Efficacy of Intravenous Levetiracetam in Neonatal Seizures

Completed · Phase 1/Phase 2

Conditions studied: Neonatal Seizures

In brief

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.

Key facts

Study ID

NCT01720667

Run by

Richard H. Haas

People needed

280

Starts

2013-03-01

Expected to finish

2019-07-31

Last updated by the study team

2019-08-21

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newborns admitted to any of the study sites with electrographic seizures seizures.
• Term infants gestational age >36 weeks less than 2 weeks of age.
• Greater than 2200 grams.
• Infants for whom parental consent to participate in the study is obtained.

You may not qualify if…

• Infants who are already receiving anticonvulsants
• If serum creatinine is greater than 1.6mM
• If seizures are due to correctable metabolic abnormalities (i.e. hypoglycaemia, hypocalcemia, hyponatremia)
• Subjects in whom death seems imminent, as assessed by the neonatologist.

Where it is running

• University of California, San Diego Medical Center / Neonatal Intensive Care Unit (NICU) — San Diego, California, United States

Full record on ClinicalTrials.gov

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