|- candidate number||23682|
|- NTR Number||NTR5706|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jan-2016|
|- Secondary IDs||METC Z 14T131|
|- Public Title||Validity of future risk prediction of electroencephalography (EEG) in complex febrile seizures |
|- Scientific Title||Validity of future risk prediction of electroencephalography (EEG) in complex febrile seizures |
|- ACRONYM||EEG in complex febrile seizures|
|- hypothesis||this study hypotheses that EEG does not predict future seizures. If correct abandoning routinely EEG will lead to a reduction in health costs and patient/family burden. Furthermore, neurocognitive development will be investigated two years after the first febrile seizure and impact of life will be assessed.
|- Healt Condition(s) or Problem(s) studied||Seizures, EEG, Quality of life, Development|
|- Inclusion criteria||First febrile complex seizure|
Age between 6 months and 5 years
Children with a normal mental and motor development
|- Exclusion criteria||Diagnosis of epilepsy, febrile or afebrile seizures in history. |
Diagnosed with an underlying neurological disease (like mental retardation, cerebral palsy, behavioral disorders)
Mental or motor impairment
Diagnosed with an intracerebral infection (e.g. meningitis, encephalitis)
Recent trauma capitis
Use of AED
Born prematurely (before 32 weeks of gestation)
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||25-jan-2016|
|- planned closingdate||25-jan-2018|
|- Target number of participants||200|
Infant Toddler Quality of Life QuestionnaireTM (ITQOL)
Impact of event scale
WPPSI and Bayley-III-NL neuropsychological tests
|- Primary outcome||EEG results|
Number of future febrile or afebrile seizures
Nature of seizures (febrile or afebrile), focal or generalized
Time to future febrile or afebrile seizure
|- Secondary outcome||Quality of life questionnaire: Infant Toddler Quality of Life QuestionnaireTM (ITQOL) |
Impact of event scale
Development: WPPSI and Bayley-III-NL scores
Use of AEDs and side effects
|- Timepoints||Two years of inclusion, 2 years of follow up|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| B Panis|
|- CONTACT for SCIENTIFIC QUERIES|| B Panis|
|- Sponsor/Initiator ||Zuyderland Medical Center, Heerlen|
(Source(s) of Monetary or Material Support)
|Zuyderland Medical Center, Heerlen|
|- Brief summary||Febrile seizures are seizures provoked by fever. This in contrary to epilepsy, which involves unprovoked seizures. Febrile seizures affect 2-4% of children in Europe, and are the most common form of seizures encountered in children.
Febrile seizures can be classified as simple or complex. Simple febrile seizures have no focal features, are short in duration, at least less than 15 minutes, and occur once per 24 hours in a neurologically and developmentally normal child. Complex febrile seizures are seizures that either suggest a focal nature, have a duration of more than 15 minutes, or occur more than once in a period of 24 hours. After experiencing a febrile seizures, the risk of recurrence is elevated compared to the risk in children with no history of febrile seizures (i.e. 30%). After a simple febrile seizure, the risk of developing unprovoked seizures (epilepsy) is not elevated, and development is not interfered. For this reason, these seizures are named benign. Children with complex febrile seizures have a greater risk for development of epilepsy (4-12%) and delayed neurocognitive development.
A child with a simple febrile seizure usually does not need to be hospitalized and most children with simple febrile seizures will not be seen by a pediatrician or child neurologist. Despite its excellent prognosis, and its lacking need of future diagnostic evaluations, it is a cause of high anxiety among parents.
Most children with complex febrile seizures will be transferred to a hospital to evaluate cause, to exclude a CNS infection and to manage follow up. It is common to recommend an electroencephalography (EEG) for children with complex febrile seizures, to identify the nature of the underlying acute or remote cerebral pathology and to predict the risk of future seizures. However, limited evidence is available to guide future diagnostic evaluations. In a recent Cochrane review by Shah et al. in 2014, it was found that no evidence exists to support or refute the use of an EEG after complex febrile seizures among children. Whether or not a child with a complex seizure will undergo an EEG, cerebral imaging or future follow up of development is a doctor’s personal choice and might be based on personal experiences.
We plan to do a trial to investigate the rationale of EEG in children with complex febrile seizures. Because the results of EEG are sometimes used to guide AED prescription (which is a potential confounding factor), we aim to do a double blind controlled trial. Two groups are compared. One group with the results of the EEG blinded and one group of children with the results of the EEG open. By comparing these two groups, we can answer the question: does performing an EEG lead to more treatment, but furthermore we can answer the question of the rationale of EEG two years after follow up, when we will open the results of EEG.
Furthermore, we will assess the impact of complex febrile seizures on the quality of life and on neurocognitive and motor development.
|- Main changes (audit trail)|
|- RECORD||30-jan-2016 - 25-apr-2016|