Clinical trial NCT03107507: Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG
Official title: Efficacy of Levetiracetam in Control of Neonatal Seizures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neonatal Seizures
Keywords: EEG with Periodic Abnormalities
Levetiracetam
Phenobarbitone
neonatal seizures
Neurodevelopmental Abnormality
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Efficacy of levetiracetam in control of neonatal seizures as a first line versus phenobarbital through assessment of seizure burden.
timeFrame: 72 hours
measure: Efficacy of levetiracetam in rapid control of neonatal seizures compared to phenobarbital.
timeFrame: 72 hours
Secondary outcomes:
measure: Dose escalation data about levetiracetam through studying the efficacy of further dose administration in non responders.
timeFrame: 72 hours
measure: Adequacy of levetiracetam as a single agent antiepileptic drug in control of neonatal seizures.
timeFrame: 30 days
measure: Accuracy of amplitude integrated EEG monitoring in detecting neonatal seizures before and after antiepileptic drug use.
timeFrame: 48 hours
measure: Effect of levetiracetam on aEEG background activity of participants.
timeFrame: 48 hours
measure: The short term clinical outcome of patients with neonatal seizures after treatment with levetiracetam.
timeFrame: 3 months
measure: The short term electroencephalographic outcome of patients with neonatal seizures after treatment with levetiracetam
timeFrame: 3 months
Other outcomes:
measure: To gather safety information on levetiracetam use in neonates
timeFrame: 72 hours
Locations:
city: Cairo Governorate
country: Egypt
facility: Cairo University Children's Hospital (Abulreesh)
Study officials:
affiliation: Cairo University
name: Omneya G Afify, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Iman F Iskander, MD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Aliaa A Ali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Yara S Shaheen, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Walaa Shaarany, MD
role: PRINCIPAL_INVESTIGATOR
References: