Efficacy of Intravenous Levetiracetam in Neonatal Seizures

This project aims to improve the treatment of neonatal seizures. Current treatments are
poorly effective and have significant side effects.

Levetiracetam (LEV) has great potential as a treatment for neonatal seizures but is not
approved for use in children less than 2 years of age.

This study aims to obtain essential data regarding the efficacy and safety of LEV in this
vulnerable and under researched population and simultaneously to develop EEG monitoring
systems that facilitate seizure detection and research.

Specific aims are:

1. To determine the efficacy of intravenous LEV in terminating neonatal seizures when given
as first line therapy.

2. To obtain dose escalation data by studying the additional efficacy of a further dose in
non responders.

3. To obtain additional pharmacokinetic data to confirm findings from our previous
pharmacokinetic study.

4. To obtain further safety data of LEV in neonates.

5. To prove the feasibility of centralized remote monitoring of continuous EEG monitoring
in the Neonatal Intensive Care Unit (NICU) via the internet and test a promising
automated neonatal seizure detection algorithm.

The study design is a phase 2 randomized blinded controlled study.

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.