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Levetiracetam (Keppra®) in neonates


- candidate number2515
- NTR NumberNTR930
- ISRCTNISRCTN53371491
- Date ISRCTN created11-apr-2007
- date ISRCTN requested24-mrt-2007
- Date Registered NTR12-mrt-2007
- Secondary IDs 
- Public TitleLevetiracetam (Keppra®) in neonates
- Scientific TitleSafety of intravenous levetiracetam for in neonates with seizures
- ACRONYM-
- hypothesisThe 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) studiedNeonatal seizures, Antiepileptics, Levetiracetam, Safety
- Inclusion criteria1. 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 criteria1. Newborn gestational age < 37 weeks; 2. Birth weight < 1500 grams
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-apr-2007
- planned closingdate1-apr-2008
- Target number of participants10
- InterventionsKeppra iv 20 mg/kg, when no respons another 20 mg/kg; 15 times withdrawal from blood from arterial catheter
- Primary outcome1. 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 outcomeIncrease of epileptic activity and drug interaction will be determined or registered
- Timepoints
- Trial web site
- statusplanned
- 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 summaryDetermining safety and pharmacokinetic and -dynamic properties of levetiracetam in neonates with seizures
- Main changes (audit trail)
- RECORD12-mrt-2007 - 12-apr-2007


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