This study is looking at how much Levetiracetam (an anti-seizure medication) is safe and effective for treating seizures in newborns. Researchers believe that a higher dose of Levetiracetam than currently used might work better. If your baby is a newborn (up to 1 month old, weighing over 2200g) and is having or at risk for seizures, they might be able to join. The study will start with Levetiracetam and if seizures continue, some babies will receive a higher dose of Levetiracetam while others will receive phenobarbital (another seizure medication). The main goal is to find the highest safe dose of Levetiracetam. The current status of this study is unclear, and it plans to enroll 133 participants.

Study design

This is a Phase IIb, open-label study, meaning both you and the study team will know which treatment your baby is receiving. It involves increasing doses of Levetiracetam and includes a comparison group receiving phenobarbital.

What's involved

Your baby will receive Levetiracetam intravenously (through a vein) and will have continuous video EEG monitoring to check for seizures. If seizures continue, they may be randomized to receive a higher dose of Levetiracetam or phenobarbital.

Compensation

Not stated in the trial record.

Follow-up

The main goal of the study, finding the maximum safe and tolerated dose of Levetiracetam, will be measured at 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.