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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.


- candidate number1500
- NTR NumberNTR306
- ISRCTNISRCTN61541169
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleThe effect of treatment of neonatal electrographic seizures, detected with the continuous cerebral function monitoring, with respect to occurrence of postneonatal epilepsy and neurodevelopmental outcome.
- Scientific TitleThe effect of treatment of neonatal electrographic seizures, detected with the continuous cerebral function monitoring, with respect to occurrence of postneonatal epilepsy and neurodevelopmental outcome.
- ACRONYMSuSeQue (subclinical seizure question)
- hypothesisWe hypothesize that without continuous EEG registration, subclinical electrographic seizures will be missed. Repetive ictal seizures and a sublcinical 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.
- Healt Condition(s) or Problem(s) studiedNeonatal seizures
- Inclusion criteriaFullterm 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.
- Exclusion criteriaPreterm infants (<37 wks GA) and fullterm infants with neonatal seizures admitted after the first 24 hours after birth. Infants with chromosomal disorders, congenital anomalies and meningitis.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2003
- planned closingdate1-jul-2007
- Target number of participants120
- InterventionsFollowing initiation of aEEG registration and the occurrence of the first subclinical seizure, and following parental consent, the infant will be randomised to group A (treatment of clinical as well subclinical seizures as detetected on the aEEG) or 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).
- Primary outcome1. What is the number of electrographic seizure discharges missed if you do not monitor continuously;
2. Does instantaneous treatment of electrographical seizures lead to:
a. A reduction of seizure discharges;
b. Less damage on the neonatal MRI.
- Secondary outcomeDoes treatment of neonatal seizures lead to a reduced risk of postneonatal epilepsy (PNE) and d) an improved neurodevelopmental outcome at 24 months.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. L.S. Vries, de
- CONTACT for SCIENTIFIC QUERIESProf. Dr. L.S. Vries, de
- Sponsor/Initiator University Medical Center Utrecht (UMCU), AZU
- Funding
(Source(s) of Monetary or Material Support)
Dutch Epilepsy Foundation (NEF)
- PublicationsVan Rooij LCM, Toet MC, Rademaker MCA, Groenendaal, de Vries LS. Cardiac arrhythmia in Neonates Receiving Lidocaine as Anticonvulsive Treatment. Eur J Pediatr 2004Eur J Pediatr. 2004;163:637-41.
van Rooij LG, Toet MC, Osredkar D, van Huffelen AC, Groenendaal F, de Vries LS.Recovery of amplitude integrated electroencephalographic background patterns within 24 hours of perinatal asphyxia.Arch Dis Child Fetal Neonatal Ed. 2005;90:F245-51.
Toet MC, Groenendaal F, Osredkar D, van Huffelen AC, de Vries LS.Postneonatal epilepsy following amplitude-integrated EEG-detected neonatal seizures Pediatr Neurol 2005; 32:241-7
- Brief summaryNeonatal seizures are commonly seen following perinatal asphixia. Since the introduction of the continuous bedside simplified EEG monitoring devices, it has become clear that subclinical seizures occur in about 50-60% of all neonatal seizures.
As yet it is not known whether treatment of these subclinical seizures is necessary and will improve longterm outcome.
Treatment of neonatal seizures is a challenge and the most commonly used anti-epileptic drugs are only effective in about 50% of the cases.
To resolve the problem whether treatment of subclinical seizures is required or unnecessary and maybe even deleterious to the developing brain, a randomised controlled trial (RCT) is performed.
In the randomised trial infants will be either treated with antiepileptic drugs when they have clinical as well as subclinical seizures, as detetected on the amplitude integrated EEG.
In the other arm, only clinical seizures will be treated and the aEEG will record but will be blinded.
- Main changes (audit trail)
- RECORD9-sep-2005 - 3-dec-2009


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