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Levetiracetam (Keppra®) in neonates

Levetiracetam (Keppra®) in neonates - -

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30449
Enrollment
10
Registered
2007-01-22
Start date
2007-05-12
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

convulsions epileptic seizures

Interventions

Levetiracetam intravenously as a second or third line anticonvulsant, 20 mg/kg
in the absence of a response after 10 min. a second dose of 20 mg/kg will be given.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

Exclusion criteria: ·newborn gestational age

Design outcomes

Primary

MeasureTime frame
Safety profile of LEV in neonates. Outcome parameters as liver-, kidney- and metabolic function, electrolytes, hemodynamic effects (heart rate/arrythmias, arterial bloodpressure/hypotension). Investigation of pharmacokinetic and - dynamic properties of LEV at neonates.

Secondary

MeasureTime frame
Increase of epileptic seizures and medication interaction will be measured.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)