Clinical trial NCT06726408: Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring
Official title: Critical Care Optimized Pediatric Quantitative EEG
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neonatal Intensive Care Unit
Keywords: Quantitative neuromonitoring
Pediatric and neonatal critical care
Neonatal encephalopathy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 120
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring

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.

Eligibility criteria: Inclusion Criteria :

* 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).

Exclusion Criteria :

* 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.

Primary outcomes:
measure: Evaluate the diagnostic performance of neuromonitoring combining quantitative EEG and possible interpretation by a neurophysiologist in detecting neurological impairment.
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
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