Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
11/08/2008
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

Prof L.S. de Vries

ORCID ID

Contact details

University Medical Center Utrecht
P.O. Box 85090
Utrecht
3508 AB
Netherlands
l.devries@wkz.azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR306

Study information

Scientific title

Acronym

SuSeQue (subclinical seizure question)

Study hypothesis

We hypothesise that without continuous Electroencephalogram (EEG) registration, subclinical electrographic seizures will be missed. Repetitive ictal seizures and a subclinical status epilepticus may be deleterious to the immature brain. On the other hand the use of antiepileptic drugs may also have adverse effects, especially to the developing brain.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Neonatal seizures

Intervention

Following initiation of aEEG registration and the occurrence of the first subclinical seizure, and following parental consent, the infant will be randomised to:
1. Group A: treatment of clinical as well subclinical seizures as detected on the aEEG
2. Group B: the aEEG will be blinded, and only clinical seizures will be treated. Intermittent standard EEG can be performed and in case the EEG shows a status epilepticus this can be treated, but in case a subclinical seizure is seen on the standard EEG, this will not be treated with anti-epileptic drugs

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. What is the number of electrographic seizure discharges missed if you do not monitor continuously
2. Does instantaneous treatment of electrographical seizures lead to:
2.1. A reduction of seizure discharges
2.2. Less damage on the neonatal Magnetic Resonance Imaging (MRI)

Secondary outcome measures

Does treatment of neonatal seizures lead to a reduced risk of Post-Neonatal Epilepsy (PNE) and an improved neurodevelopmental outcome at 24 months.

Overall trial start date

01/07/2003

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Full term infants admitted to the neonatal intensive care unit, within the first 24 hours after birth with subclinical seizures on the aEEG, in 8 Dutch and 3 Belgium centres.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Preterm infants (less than 37 weeks Gestational Age [GA]) and full term infants with neonatal seizures admitted after the first 24 hours after birth
2. Infants with chromosomal disorders, congenital anomalies and meningitis

Recruitment start date

01/07/2003

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Belgium, Netherlands

Trial participating centre

University Medical Center Utrecht
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Charity

Funder name

Dutch Epilepsy Foundation (NEF) (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