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

NCT03107507 | Unknown Phase 4 FDA Drug

• 1 other identifier: YSShaheen
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

EEG with Periodic Abnormalities; Levetiracetam; Phenobarbitone; neonatal seizures; Neurodevelopmental Abnormality

Outcome Measures

Primary Outcomes (2)

• Efficacy of levetiracetam in control of neonatal seizures as a first line versus phenobarbital through assessment of seizure burden.

  Number of seizures before and after levetiracetam administration in comparison to phenobarbital.

  72 hours

• Efficacy of levetiracetam in rapid control of neonatal seizures compared to phenobarbital.

  Number of hours taken to achieve seizure freedom after administration of levetiracetam versus phenobarbital.

  72 hours

Secondary Outcomes (6)

• Dose escalation data about levetiracetam through studying the efficacy of further dose administration in non responders.

  72 hours

• Adequacy of levetiracetam as a single agent antiepileptic drug in control of neonatal seizures.

  30 days

• Accuracy of amplitude integrated EEG monitoring in detecting neonatal seizures before and after antiepileptic drug use.

  48 hours

• Effect of levetiracetam on aEEG background activity of participants.

  48 hours

• The short term clinical outcome of patients with neonatal seizures after treatment with levetiracetam.

  3 months

Other Outcomes (1)

• To gather safety information on levetiracetam use in neonates

  72 hours

Study Arms (2)

Levetiracetam

ACTIVE COMPARATOR

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

Drug: Levetiracetam

Phenobarbital

ACTIVE COMPARATOR

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

Drug: Phenobarbital

Interventions

Levetiracetam 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.

Levetiracetam

Phenobarbital 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.

Phenobarbital

Eligibility Criteria

• Age: 1 Hour - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Children's Hospital (Abulreesh)

Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

Levetiracetam; Phenobarbital

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Barbiturates; Pyrimidinones; Pyrimidines

Study Officials

• Omneya G Afify, MD

  Cairo University

  STUDY CHAIR

• Iman F Iskander, MD

  Cairo University

  STUDY DIRECTOR

• Aliaa A Ali, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Yara S Shaheen, MSc.

  Cairo University

  PRINCIPAL INVESTIGATOR

• Walaa Shaarany, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yara S Shaheen, Msc

CONTACT

01227981313; yarasalah.shaheen@gmail.com

Aliaa A Ali, MD

CONTACT

draliaaadel@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: April 11, 2017
• Study Start: March 25, 2017
• Primary Completion: October 30, 2017
• Study Completion: December 30, 2017
• Last Updated: April 11, 2017

Record last verified: 2017-03

Locations

EG (1)