evetiracetam (Keppra®) in neonates
- Registration Number
- NL-OMON22555
- Lead Sponsor
- same
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
1. All neonates with electrographical epileptic seizures, diagnosed by EEG,
a. with or without clinical signs;
b. multiple (>1 in 30’), defined as the evolution of sudden, repetitive evolving stereotyped forms with a definite beginning, middle and end, lasting at least 8 seconds;
c. or status epilepticus, defined as continuous seizure activity for at least 30 minutes or recurrent seizure activity for >50% of the entire recording duration.
2. Newborn gestational age > 37 weeks, birth weight > 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 10-15 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 CNS infections;
5. Arterial catheter
1. Newborn gestational age < 37 weeks;
2. Birth weight < 1500 grams
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Safety profile of LEV in neonates;<br>2. Safety outcome parameters as liver, kidney and metabolic function, electrolytes, hemodynamic effects (heart rate/arrhythmia, arterial blood pressure/hypotension). <br>3. Investigation of pharmacokinetic and –dynamic properties of LEV in neonates.
- Secondary Outcome Measures
Name Time Method Increase of epileptic activity and drug interaction will be determined or registered