Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG

Neonatal Seizures Clinical Trial

Official title: Efficacy of Levetiracetam in Control of Neonatal Seizures

Status Recruiting

Clinical Trial Summary

Over the last three decades, several tools have been developed to enhance the detection and treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as a first-line therapy worldwide. However, newer anti-epileptic drugs (AED) s such as, levetiracetam, bumetanide, and topiramate are increasingly being applied to the neonatal population, offering the potential for seizure treatment with a significantly better side-effect profile.

Levetiracetam is a very promising medication for the treatment of neonatal seizures. It has been in clinical use for almost a decade in adults and older children with good efficacy, an excellent safety profile and near ideal pharmacokinetic characteristics. It has been approved and used for treatment of seizures in infants starting one month of age since 2012.

The investigators are comparing the efficacy of levetiracetam to that of phenobarbital as a first-line drug in control of neonatal seizures. The investigators monitor the efficacy through assessment of frequency of seizures before and after drug administration, amplitude integrated EEG changes in background activity and seizure frequency in participants, duration taken for participants to be seizure free and short term neurodevelopmental outcome and EEG at 3 months of age

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Neonatal Seizures
• Seizures

• NCT number: NCT03107507
• Study type: Interventional
• Source: Cairo University
• Contact: Yara S Shaheen, Msc
• Phone: 01227981313
• Email: yarasalah.shaheen@gmail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: March 25, 2017
• Completion date: December 30, 2017