Hereto, the project wants to meet the following goals:1. To produce an EEG instrument for continuous brain monitoring, the NeoGuard, enabling automated detection of neonatal seizures and abnormalities in the EEG background pattern. The neonatal…
ID
Source
Brief title
Condition
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To develop a first neonatal, fully automated and continuous brain monitoring to
be used in the daily practice.
The automated seizure detector diagnoses seizures with a sensitivity of more
than 85% and less than 1 false alarm per 3 hours.
With automated background EEG grading, the prediction of short term outcome (on
basis of MRI scores)and long term outcome (on basis of follow-up at two years)
can be made with a sensitivity of more than 85% and specificity of more than
80%.
The following questions will be answered: is the software for automatic
detection of seizures valuable? Therefore the alarms will be compared with the
expert labelling of seizures seen on the classical EEG
Objective quantification of the background EEG is important. The goal is to
define important patterns in the background EEG (e.g. sleep-wake cycli, bursts,
burst suppression, entropy measures, *).
Secondary outcome
-not applicable
Background summary
The rationale of this project is thus to address the main problems with infant
EEG at this moment. These problems are the application of the EEG electrodes,
manual (subjective) interpretation of the signals and the around the clock
availability of EEG experts being too difficult and too time consuming for
routine use.
Study objective
Hereto, the project wants to meet the following goals:
1. To produce an EEG instrument for continuous brain monitoring, the NeoGuard,
enabling automated detection of neonatal seizures and abnormalities in
the EEG background pattern. The neonatal nurse or clinician should be able to
use the instrument after a short instruction workshop, although verifying
automated detections with the raw EEG signal by a supervising expert clinical
neurophysiologist will remain preferable.
2. To validate the automated seizure detection program and to
validate the background EEG classification program by comparing it with expert
EEG interpretation, the extent of brain damage on MRI and psychomotor
development of the patients. This will happen in the neonatal intensive care
units in Leuven, Antwerp and Rotterdam.
The clinical study will focus on the term infant with encephalopathy.
Once the project is finished we would like to provide different major neonatal
units in Flanders (Leuven, Antwerp, Brussels) as well as the EMC Rotterdam with
a prototype of the NeoGuard. After a validation study, also large maternity
units will be provided with a NeoGuard, coupled with one or more workshops.
2 hypotheses will be tested:
1.The automated seizure detector diagnoses seizures with a sensitivity of more
than 85% and less than 1 false alarm per 3 hours.
2. With automated background EEG grading, the prediction of short term outcome
(on basis of MRI scores)and long term outcome (on basis of follow-up at two
years) can be made with a sensitivity of more than 85% and specificity of more
than 80%.
Study design
All babies that fulfill specific criteria will be admitted to the study after
parenteral consent. The study will be started as quick as possible in order to
collect the data as close to birth as possible.
Treatment of convulsions will be according to the choice of the attending
physician. However, the anticonvulsants will be noted in the data.
The data that will be collected are: CFM (cerebral function monitoring), EEG,
MRI performed between day 4 and 10.
At the age of 2 years a follow-up examination will be performed. This will be a
Bailey 3 PDI and MDI. An earlier follow-up (AIMS or TIMP) is planned between 4
and 6 months.
The data will be kept on a disk and sent to the central server (KU Leuven),
from where further studies can be performed.
Before the start of the measurements, ethical consent will be asked at the
parents. When the parents are not there, ethical consent to use the data can be
asked as soon as possible. As the investigations are not different than the
classical investigations done in children with peripartal asphyxia and no
intervention is done, this can be asked after the start of the EEG if it is not
possible otherwise.
After collecting the patient data, automated quantification of the EEG pattern
will happen.
Study burden and risks
The patients included in the study won't be treated otherwise than non-included
patient. The only difference is that the EEG is made with 17 electrodes in
stead of 8 or 12 electrodes.
Herestraat 49
leuven 3000
BE
Herestraat 49
leuven 3000
BE
Listed location countries
Age
Inclusion criteria
Term babies with an umbilical pH less than 7,1
APGAR score less than 6 at 5 minutes
Thompson score more than 4.
Term babies with clinical diagnosis of neonatal seizures
Exclusion criteria
postmenstrual age less than 36 weeks, or postmenstrual age more then 36 weeks and at least one of the other criteria not fulfilled
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43296.078.13 |