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

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Neonatal Seizures

Treatments: Drug: Phenobarbital; Drug: Levetiracetam

Study type: Interventional

Funder types: Other

Identifiers

NCT03107507

YSShaheen

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 1 hour to 30 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Levetiracetam

Active Comparator group

Description:

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

Treatment:

Drug: Levetiracetam

Phenobarbital

Active Comparator group

Description:

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

Treatment:

Drug: Phenobarbital