|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR930 |
|
Date of registration:
|
12/03/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Levetiracetam (Keppra®) in neonates
|
|
Scientific title:
|
Safety of intravenous levetiracetam for in neonates with seizures - - |
|
Date of first enrolment:
|
1/4/2007 |
|
Target sample size:
|
10 |
|
Recruitment status: |
pending |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=930 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: -
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
L.S.
Smit |
|
Address:
|
Erasmus Medical Center, Sophia Children's Hospital, Department of Neonatology Intensive Care
Rotterdam
The Netherlands |
|
Telephone:
|
+31 10 4636077 |
|
Email:
|
l.s.smit@erasmusmc.nl |
|
Affiliation:
|
|
|
|
Name:
|
L.S.
Smit |
|
Address:
|
Erasmus Medical Center, Sophia Children's Hospital, Department of Neonatology Intensive Care
Rotterdam
The Netherlands |
|
Telephone:
|
+31 10 4636077 |
|
Email:
|
l.s.smit@erasmusmc.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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: 1. Newborn gestational age < 37 weeks;
2. Birth weight < 1500 grams
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Neonatal seizures, Antiepileptics, Levetiracetam, Safety
|
|
Intervention(s)
|
Keppra iv 20 mg/kg, when no respons another 20 mg/kg;
15 times withdrawal from blood from arterial catheter
|
|
Primary Outcome(s)
|
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(s)
|
|
Increase of epileptic activity and drug interaction will be determined or registered
|
|
Secondary ID(s)
|
|
ISRCTN53371491
|
|
Source(s) of Monetary Support
|
|
Erasmus Medical Center, Sophia Children's Hospital
|
|