A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Nov 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Levetiracetam (LEV) for treating seizures in newborns. Researchers want to find out the highest dose of LEV that is safe for infants who are either having seizures or are at risk of developing them. The trial will involve monitoring the babies closely with special video equipment to track their brain activity. It will include different phases, starting with babies who have mild to moderate seizures and later including those with more severe seizures, to ensure the findings can help a wide range of infants.

To be eligible for this study, babies need to be born at term (between 35 and 44 weeks of pregnancy), weigh more than 2200 grams, and show signs of having seizures or be considered at risk for them. Parents will need to understand the study and give their permission for their baby to participate. If enrolled, babies will receive an initial dose of LEV, and if their seizures continue, they may be randomly assigned to receive either a higher dose of LEV or a different medication. This trial is an important step in improving treatment options for newborns with seizures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • at risk for seizures or suspected to be having seizures;
• • all seizure aetiologies except correctable metabolic abnormalities such as hypoglycaemia and hypocalcaemia;
• • Term neonates (corrected gestational age between 35 and 44 weeks, postnatal age less than 28 days);
• • weight \> 2200g.
• • Parental ability to comprehend and provide written informed consent
• Exclusion Criteria:
• • Cumulative seizure burden of 8 minutes/ hour or more in phases 1 and 2, Cumulative seizure burden of 30 minutes/hour or more in phase 3;
• • Renal failure defined as anuria in the first 24 hours of life;
• • Subjects in whom death seems imminent;
• • Seizures caused by correctable metabolic abnormality, such as hypocalcaemia, hypoglycaemia.