evetiracetam (Keppra®) in neonates

Conditions: epileptic seizures in neonates admitted to the intensive care unit
MedDRA version: 9.1Level: LLTClassification code 10041350Term: Somnolence neonatal
MedDRA version: 9.1Level: LLTClassification code 10013573Term: Dizziness
MedDRA version: 9.1Level: LLTClassification code 10004210Term: Behavioural disorder

Registration Number: EUCTR2006-006804-12-NL

Lead Sponsor: ErasmusMedical Center-Sophia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

·newborn gestational age > 37 weeks, birth weight > 1500 grams
·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)
·after correction or treatment of metabolic causes of the as inborn errors, hypoglycaemia or hypocalcaemia or CNS infections
·arterial catheter

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·newborn gestational age < 37 weeks, birth weight < 1500 grams

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Safety profile of LEV in neonates. Pharmacokinetic and -dynamic properties;Main Objective: safety profile of LEV in neonates. Safety outcome parameters as liver, kidney and metabolic function, electrolytes, hemodynamic effects (heart rate/arrhythmia, arterial blood pressure/hypotension). Investigation of pharmacokinetic and –dynamic properties of LEV in neonates.;Secondary Objective: increase of epileptic activity and drug interaction will be determined or registered.

Secondary Outcome Measures