The effect of treatment of neonatal electrographic seizures, detected with the continuous cerebral function monitoring, with respect to occurrence of postneonatal epilepsy and neurodevelopmental outcome.
| ISRCTN | ISRCTN61541169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61541169 |
| Protocol serial number | NTR306 |
| Sponsor | University Medical Centre Utrecht (UMCU) (Netherlands) |
| Funder | Dutch Epilepsy Foundation (NEF) (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 11/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof L.S. de Vries
Scientific
Scientific
University Medical Center Utrecht
P.O. Box 85090
Utrecht
3508 AB
Netherlands
| l.devries@wkz.azu.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | SuSeQue (subclinical seizure question) |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
1. What is the number of electrographic seizure discharges missed if you do not monitor continuously |
| Key secondary outcome measure(s) |
Does treatment of neonatal seizures lead to a reduced risk of Post-Neonatal Epilepsy (PNE) and an improved neurodevelopmental outcome at 24 months. |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 120 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
