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.
ID
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Determining safety and pharmacokinetic and -dynamic properties of levetiracetam in neonates with seizures
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
Keppra iv 20 mg/kg, when no respons another 20 mg/kg;
15 times withdrawal from blood from arterial catheter
Publiek
L.S. Smit
Rotterdam
The Netherlands
+31 10 4636077
l.s.smit@erasmusmc.nl
Wetenschappelijk
L.S. Smit
Rotterdam
The Netherlands
+31 10 4636077
l.s.smit@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Newborn gestational age < 37 weeks;
2. Birth weight < 1500 grams
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL907 |
| NTR-old | NTR930 |
| Ander register | : |
| ISRCTN | ISRCTN53371491 |