Actively Recruiting
Critical Care Optimized Pediatric Quantitative EEG for Neonatal Intensive Care Monitoring
Led by Nantes University Hospital · Updated on 2026-03-10
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial focuses on critically ill children under 2 years old in intensive care who may experience seizures that affect brain function. It aims to develop and assess a neuromonitoring interface suitable for pediatric and neonatal intensive care units to improve seizure detection and neurological monitoring. The study evaluates the combination of advanced EEG techniques and neurophysiologist input to enhance detection of seizures and background brain abnormalities in these patients. The research is conducted in three phases: first, configuring an interface displaying an 8-channel amplitude EEG (aEEG) trace alongside tools for seizure detection and reading support. Second, training clinical teams on electrode placement and use of these aids. Third, including patients for continuous neuromonitoring with 10 electrodes applied to the child's scalp (instead of the usual 5). Clinicians will analyze the quantitative EEG traces with support from seizure detection software and neurophysiologist review during office hours. Participants will have EEG monitoring data collected in 12-hour periods with continuous access for bedside interpretation and neurophysiologist reading on demand. The study measures include the diagnostic accuracy of this neuromonitoring approach for neurological impairment and seizures over 48 hours, classification of critical encephalopathy, impact of tracing aids on clinical confidence, anticonvulsant treatment use, and hypothermia treatment decisions. This observational study runs until 2027 and involves ongoing expert review and evaluation of recorded EEG data.
CONDITIONS
Brief 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 intensive care with an indication for neuromonitoring
- Written non-opposition from legal representatives
- Patients affiliated with or beneficiaries of a social security or similar scheme
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 hours
Participants undergo neuromonitoring using 10 electrodes with continuous access to quantitative EEG tools and neurophysiologist support during working hours.
Continuous monitoring over 48 hours
Trial Site Locations
Total: 1 location
1
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
Research Team
N
Noura ZAYAT, PH
P
Pierre BOURGOIN, PH
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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