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

NCT ID: NCT03107507

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-25
• Study Completion Date: 2017-12-30

Brief 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

Conditions

Neonatal Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Levetiracetam

Levetiracetam given in oral form via oro-gastric tube, first a bolus dose 40-50mg/kg then maintenance dose 10-30 mg/kg/day divided every 12 hours.

Duration: until seizure free

Group Type: ACTIVE_COMPARATOR

Levetiracetam

Intervention Type: DRUG

Given in a bolus dose first 50mg/kg as levetiracetam reaches a therapeutic serum level rapidly in 1.3 hours. Titration will not be attempted in our study to reach drug level rapidly and consequent rapid effective control of seizures. Maintenance dose is then given at a dose of 10 - 40mg/kg/day divided every 12 hours.

Phenobarbital

Phenobarbital given in IV form, loading dose 20mg/kg that can be repeated after a 20 minute interval not to exceed 40mg/kg then maintenance dose 2-4 mg/kg/day divided every 12 hours.

Duration: until seizure free

Group Type: ACTIVE_COMPARATOR

Phenobarbital

Intervention Type: DRUG

Phenobarbital is given intravenously in the form of a loading dose of 15mg/kg that can be repeated after a 20 minute interval not to exceed 30mg/kg then a maintenance dose 2-4 mg/kg/day divided every 12 hours.

Interventions

Levetiracetam

Given in a bolus dose first 50mg/kg as levetiracetam reaches a therapeutic serum level rapidly in 1.3 hours. Titration will not be attempted in our study to reach drug level rapidly and consequent rapid effective control of seizures. Maintenance dose is then given at a dose of 10 - 40mg/kg/day divided every 12 hours.

Intervention Type: DRUG

Phenobarbital

Phenobarbital is given intravenously in the form of a loading dose of 15mg/kg that can be repeated after a 20 minute interval not to exceed 30mg/kg then a maintenance dose 2-4 mg/kg/day divided every 12 hours.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All full term neonates experiencing seizures due to; post-hypoxic or post-ischemic encephalopathy, intracerebral hemorrhage, cerebral infection, inborn errors of metabolism or malformations of cortical development

Exclusion Criteria

• Preterm neonates
• Full term neonates with seizures due to metabolic derangements (hypoglycemia, hypocalcemia or hypomagnesemia)
• Full term neonates with impaired renal functions.

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yara Salah Shaheen

Pricipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omneya G Afify, MD

Role: STUDY_CHAIR

Cairo University

Iman F Iskander, MD

Role: STUDY_DIRECTOR

Cairo University

Aliaa A Ali, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Yara S Shaheen, MSc.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Walaa Shaarany, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University Children's Hospital (Abulreesh)

Cairo Governorate, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Yara S Shaheen, Msc

Role: CONTACT

yarasalah.shaheen@gmail.com

01227981313 ext. 002

Aliaa A Ali, MD

Role: CONTACT

draliaaadel@yahoo.com

Facility Contacts

Yara Shaheen

Role: primary

Other Identifiers

YSShaheen

Identifier Type: -

Identifier Source: org_study_id