Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
Primary outcome measure
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 study start date
01/07/2003
Overall study end date
01/07/2007
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Neonate
Sex
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
Study participating centre
University Medical Center Utrecht
Utrecht
3508 AB
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (Netherlands)
Sponsor details
PO Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
http://www.umcutrecht.nl/zorg/
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|