Is continuous EEG registration with a 9 and 21 channel EEG with SL detection an approved method for the detection of seizures in term neonates with perinatal hypoxia-ischemia? What are the sensitivity and the false positive rate of these methods in…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Analysis:
Sensitivity and false positive rates will be calculated for each detection
method. The visual inspected EEG will be used as gold standard and will be
compared with the 9 and 21 channel EEG with SL detection and the practical
standard, the aEEG. Furthermore, the correlation between the detection method
will be assessed with the Spearman Ranks. A p value <0.05 will be designated as
statistically significant.
Secondary outcome
na
Background summary
Epileptic seizures are frequently encountered in term neonates with perinatal
hypoxia-ischemia. Since a considerable proportion of these seizures is not
detected clinically, and early detection and treatment can improve prognosis
positively, it is important to have a sensitive, bedside monitoring system for
the detection of seizures.
Visual inspection of the 21 channel EEG is the gold standard for the detection
of seizures, however, in daily care situations it is not suitable for
continuous bedside monitoring. For that reason the amplitude-integrated EEG
(aEEG) has been used in NICUs. The aEEG is a 2 channel EEG with compression in
time. Based on pattern recognition the back ground pattern will be judged and
the presence of seizures will be monitored. Although it is a practical monitor,
it has been shown that not all type of seizures are being recognized by
clinicians who daily work with this aEEG. In 2002 the synchronization
likelihood (SL), a measure of nonlinear interdependencies between time series
has been introduced by Stam and Van Dijk. This method characterizes detection
of dynamic processes of neuronal networks and their interactions. When a
certain threshold has been reached it could indicate the presence of a seizure
in neonatal EEGs with a sensitivity of 65,9% and a specificity of 89,8%.
Study objective
Is continuous EEG registration with a 9 and 21 channel EEG with SL detection an
approved method for the detection of seizures in term neonates with perinatal
hypoxia-ischemia? What are the sensitivity and the false positive rate of these
methods in comparison to the visual inspected EEG and the aEEG?
Study design
Methods:
- EEG registratration during 22 h with an EEG apparatus from the Clinical
Neurophysiological (CNP) unit. Scalp EEG electrodes are placed by the CNP
technicians.
- Blinded EEG registration, visual inspection afterwards by 2 clinical
neurophysiologists with a scoring system during every 10 minutes; score 0: no
epileptic activity, score 1: epileptic activity. Consensus agreement, when
needed.
-SL detection using the 9 and 21 channel EEG (Fp1, Fp2, C3, C4, T3, T4, O1, O2,
Cz). An event will be scored when during 20 seconds a certain threshold has
been
reached, preceded by a 20 second period below the threshold value. Scoring
system every 10 minutes: score 0: no registered events, score 1: one or more
registered events.
- During the same time period an aEEG will be registered, on which clinical
treatment of the seizures will take place, as usual. Two neonatologists will
perform blinded inspection of the aEEG, based on pattern recognition
afterwards. Score 0: no epileptic activity, score 1: epileptic activity.
Consensus agreement, when needed.
Study burden and risks
The child will be connected to an extra monitor for 22 hours. There will be no
increased burden for the patient.
With this research additional information can be gained about potential bedside
brain monitor techniques to identify epileptic seizures earlier and
objectively. In the near future other children may be treated earlier and more
effective with anti-convulsive drugs to improve long term outcome after
perinatal asphyxia.
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria: neonates with gestational duration * 35 weeks with an arterial umbilical pH < 7,00 or an Apgar score * 5 at 5 minutes, present within 24 h after birth at the neonatal intensive care unit of the VU medical center.
Exclusion criteria
Premature neonates; Suspected chromosomal/syndromal abnormalities or metabolic disturbances. Neonates with a skull defect. Inability from the Clinical Neurophysiological (CNP) unit to register the EEG.
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 | NL13358.029.06 |