evetiracetam (Keppra®) in neonates: safety of intravenous levetiracetam for neonates with seizures

Not Applicable

Completed

• Conditions: eonatal seizures; Nervous System Diseases; Episodic and paroxysmal disorders

• Registration Number: ISRCTN53371491
• Lead Sponsor: Erasmus Medical Centre (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-11
• Study Completion: 2008-04-01
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. All neonates with electrographical epileptic seizures, diagnosed by Electroencephalogram (EEG):
a. with or without clinical signs
b. multiple (greater than one in 30), defined as the evolution of sudden, repetitive evolving stereotyped forms with a definite beginning, middle and end, lasting at least eight seconds
c. or status epilepticus, defined as continuous seizure activity for at least 30 minutes or recurrent seizure activity for greater than 50% of the entire recording duration
2. Newborn gestational age greater than 37 weeks, birth weight greater than 1500 grams
3. Refractory to phenobarbitone up to 40 mg/kg or refractory to phenobarbitone up to 40 mg/kg and midazolam up to 0.5 mg/kg (raised from 0.1 mg/kg every 10 to 15 minutes when effect fails) (depending on moment of referral with history of medication)
4. After correction or treatment of metabolic causes of the as inborn errors, hypoglycaemia or hypocalcaemia or Central Nervous System (CNS) infections
5. Arterial catheter

Exclusion Criteria

1. Newborn gestational age less than 37 weeks
2. Birth weight less than 1500 grams

Study & Design

• Study Type: Interventional
• Study Design: Not specified