Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring
- Conditions
- Neonatal Intensive Care Unit
- Registration Number
- NCT06726408
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed Description
This research will take place in three phases :
1. Parameterization of the interface, which will display an 8-channel aEEG trace associated with reading aids (CDSA and automated seizure detection) available to the clinician.
2. Teams' training regarding the placement of additional electrodes and the use of reading aid tools.
3. Patient's inclusion. The obtained traces will be accessible at any time for direct interpretation and can be read on demand by a neurophysiologist during office hours.
Post-hoc review of the entire EEG trace by an expert in pediatric EEG, blinded to the interpretation made at the bedside (gold standard).
Research hypothesis is that continuous neuromonitoring combining optimized quantitative EEG techniques and targeted advice from a neurophysiologist would allow the detection of a majority of seizure events requiring treatment and background trace abnormalities associated with critical encephalopathy.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the diagnostic performance of neuromonitoring combining quantitative EEG and possible interpretation by a neurophysiologist in detecting neurological impairment. 48 hours
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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