| - candidate number | 2515 |
| - NTR Number | NTR930 |
| - ISRCTN | ISRCTN53371491 |
| - Date ISRCTN created | 11-apr-2007 |
| - date ISRCTN requested | 24-mrt-2007 |
| - Date Registered NTR | 12-mrt-2007 |
| - Secondary IDs | |
| - Public Title | Levetiracetam (Keppra®) in neonates |
| - Scientific Title | Safety of intravenous levetiracetam for in neonates with seizures |
| - ACRONYM | - |
| - hypothesis | The use of parenterally administered LEV in neonatal epileptic seizures, detected electrographically, with or without clinical signs, will be safe, and pharmacokinetic and –dynamic properties of the use in neonates will be determined. |
| - Healt Condition(s) or Problem(s) studied | Neonatal seizures, Antiepileptics, Levetiracetam, Safety |
| - 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 | 1. Newborn gestational age < 37 weeks; 2. Birth weight < 1500 grams |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-apr-2007 |
| - planned closingdate | 1-apr-2008 |
| - Target number of participants | 10 |
| - Interventions | Keppra iv 20 mg/kg, when no respons another 20 mg/kg; 15 times withdrawal from blood from arterial catheter |
| - Primary outcome | 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 outcome | Increase of epileptic activity and drug interaction will be determined or registered |
| - Timepoints | |
| - Trial web site | |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | L.S. Smit |
| - CONTACT for SCIENTIFIC QUERIES | L.S. Smit |
| - Sponsor/Initiator | Erasmus Medical Center, Sophia Children's Hospital, Department of Neonatology Intensive Care |
| - Funding (Source(s) of Monetary or Material Support) | Erasmus Medical Center, Sophia Children's Hospital |
| - Publications | |
| - Brief summary | Determining safety and pharmacokinetic and -dynamic properties of levetiracetam in neonates with seizures |
| - Main changes (audit trail) | |
| - RECORD | 12-mrt-2007 - 12-apr-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl