About this trial
The detection and appropriate treatment of seizures significantly impact the neurological prognosis of patients in intensive care. Indeed, altered brain function including seizures is described in critically ill children, regardless of the reason for admission. Most seizures are subclinical and therefore impossible to diagnose without neuromonitoring tools. Despite being concidered ad Gold Standard, continuous EEG (cEEG) with video recording shows difficulty of implementation and interpretation at all hours of the day and night explaining that less than 10% of centers in France use cEEG routinely. Most departments prefer simplified techniques, including amplitude traces (aEEG) which can be used continuously at the bedside. However, the positive predictive value of aEEG in the detection of seizures does not exceed 78% and 64% in newborns and children respectively making necessary an optimization of the information provided by these techniques.
This project is a pragmatic diagnostic study that aims at developing and evaluating a neuromonitoring interface adapted to the needs of pediatric and neonatal intensive care units and meeting the requirements of neurophysiologists in terms of EEG trace quality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring. The same patient may be included multiple times.
Written non-opposition from legal representatives.
Patients affiliated with or beneficiaries of a social security or similar scheme (CMU).
Disqualifiers
Parents who do not understand French.
Inability to set up monitoring equipment (neurosurgery preventing access to electrode placement sites).
Corrected age < 37 weeks of gestation (GA) for preterm infants.
Trial population
Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring
Trial design
Case-only
Prospective
Treatments tested in this trial
Neuromonitoring with 10 electrodes
Other interventionIn case of no parental objection, the clinician may begin neuromonitoring according to standard indications. The number of electrodes applied to the child's skull will be 10 electrodes (8 recording electrodes, 1 reference electrode, and 1 ground electrode) instead of the current 5. The intensivist will analyze the quantitative EEG trace as they currently do but will also have access to additional tools for seizure detection support (CDSA and seizure detection software) and targeted review of part of the recording by a neurophysiologist in case of doubt. Access to the neurophysiologist will be available during current working hours on weekdays. Data will be collected in 12-hour periods.
Treatment groups
Trial outcomes
Primary outcomes
Evaluate the diagnostic performance of neuromonitoring combining quantitative EEG and possible interpretation by a neurophysiologist in detecting neurological impairment.
Secondary outcomes
Evaluation of the detection of convulsive seizures
Evaluation of the classification of the background tracing in critical encephalopathy grade
Impact of tracing aids on intensivists' confidence level during decision-making
Number of suitable anticonvulsant treatments
Sponsors and contacts
Click on the lead sponsor to view all of their trials.