None listed
Conditions
Interventions
Keppra iv 20 mg/kg, when no respons another 20 mg/kg
15 times withdrawal from blood from arterial catheter
Sponsors
same
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Newborn gestational age < 37 weeks; 2. Birth weight < 1500 grams
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety profile of LEV in neonates; 2. Safety outcome parameters as liver, kidney and metabolic function, electrolytes, hemodynamic effects (heart rate/arrhythmia, arterial blood pressure/hypotension). 3. Investigation of pharmacokinetic and –dynamic properties of LEV in neonates. | — |
Secondary
| Measure | Time frame |
|---|---|
| Increase of epileptic activity and drug interaction will be determined or registered | — |
Contacts
Public ContactL.S. Smit
Erasmus Medical Center, Sophia Children's Hospital, Department of Neonatology Intensive Care
Outcome results
None listed