evetiracetam (Keppra®) in neonates

Phase 2

Completed

• Conditions: convulsions; epileptic seizures; 10039911

• Registration Number: NL-OMON30449
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

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

Inclusion Criteria

·newborn gestational age >= 37 weeks, birth weight > 1500 grams
·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 10-15 minutes when effect fails)
·after correction or treatment of metabolic causes as inborn errors, hypoglycemia or hypocalcaemia or CNS infections

Exclusion Criteria

·newborn gestational age < 37 weeks, birth weight < 1500 grams

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety profile of LEV in neonates. Outcome parameters as liver-, kidney- and<br /><br>metabolic function, electrolytes, hemodynamic effects (heart rate/arrythmias,<br /><br>arterial bloodpressure/hypotension). Investigation of pharmacokinetic and -<br /><br>dynamic properties of LEV at neonates.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Increase of epileptic seizures and medication interaction will be measured.</p><br>