Condition category
Nervous System Diseases
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
13/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr L S Smit

ORCID ID

Contact details

Erasmus Medical Centre
Sophia Children's Hospital
Department of Neonatology Intensive Care
Rotterdam
3015 GJ
Netherlands
+31 (0)10 463 6077
l.s.smit@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The use of parenterally administered Levetiracetam (LEV) (Keppra®) in neonatal epileptic seizures, detected electrographically, with or without clinical signs, will be safe, and pharmaco-kinetic and -dynamic properties of the use in neonates will be determined.

Ethics approval

Approval received from the METC Erasmus MC Rotterdam on the 12th March 2007.

Study design

Non-randomised, non-controlled, clinical trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Neonatal seizures

Intervention

Keppra® intravenous (iv) 20 mg/kg, when no response another 20 mg/kg. 15 times withdrawal from blood from arterial catheter.

Intervention type

Drug

Phase

Not Specified

Drug names

Levetiracetam (Keppra®)

Primary outcome measures

1. Safety profile of LEV in neonates
2. Safety outcome parameters as liver, kidney and metabolic function, electrolytes, haemodynamic effects (heart rate/arrhythmia, arterial blood pressure/hypotension)
3. Investigation of pharmaco-kinetic and -dynamic properties of LEV in neonates

At t = 0, 12 and 24 hours physical examination will be performed. Vital signs and EEG will be monitored continuously up to 24 hours. Hepatic and kidney functions will be determined at t = 0 and t = 24 hours. LEV plasma concentrations at t = 0, 5, 15, 20, 30, 60 minutes and t = 4, 8, 12, 24, 36, 48, 60 and 72 hours.

Secondary outcome measures

Increase of epileptic activity and drug interaction will be determined or registered.

At t = 0, 12 and 24 hours physical examination will be performed. Vital signs and EEG will be monitored continuously up to 24 hours. Hepatic and kidney functions will be determined at t = 0 and t = 24 hours. LEV plasma concentrations at t = 0, 5, 15, 20, 30, 60 minutes and t = 4, 8, 12, 24, 36, 48, 60 and 72 hours.

Overall trial start date

01/04/2007

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. All neonates with electrographical epileptic seizures, diagnosed by Electroencephalogram (EEG):
a. with or without clinical signs
b. multiple (greater than one in 30), defined as the evolution of sudden, repetitive evolving stereotyped forms with a definite beginning, middle and end, lasting at least eight seconds
c. or status epilepticus, defined as continuous seizure activity for at least 30 minutes or recurrent seizure activity for greater than 50% of the entire recording duration
2. Newborn gestational age greater than 37 weeks, birth weight greater than 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 to 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 Central Nervous System (CNS) infections
5. Arterial catheter

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

10

Participant exclusion criteria

1. Newborn gestational age less than 37 weeks
2. Birth weight less than 1500 grams

Recruitment start date

01/04/2007

Recruitment end date

01/04/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3015 GJ
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Sophia Children's Hospital
Department of Neonatology Intensive Care
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes