Actively Recruiting
Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring
Led by Nantes University Hospital · Updated on 2026-03-10
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring
- Written non-opposition from legal representatives
- Patients affiliated with or beneficiaries of a social security or similar scheme (CMU)
You will not qualify if you...
- Parents who do not understand French
- Inability to set up monitoring equipment due to neurosurgery preventing electrode placement
- Corrected age less than 37 weeks of gestation for preterm infants
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
Research Team
N
Noura ZAYAT, PH
CONTACT
P
Pierre BOURGOIN, PH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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