Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring (COPeQ)

Critical Care Optimized Pediatric Quantitative EEG

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Intensive Care Unit
• Intervention / Treatment: Other: Neuromonitoring with 10 electrodes

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Noura ZAYAT, PH; Phone Number: 33 2 76 64 37 91; Email: noura.zayat@chu-nantes.fr
• Study Contact Backup: Name: Pierre BOURGOIN, PH; Phone Number: 33 2 76 64 36 12; Email: pierre.bourgoin@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes
    • Contact: Noura Zayat; Phone Number: 02.76.64.37.91; Email: noura.zayat@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the diagnostic performance of neuromonitoring combining quantitative EEG and possible interpretation by a neurophysiologist in detecting neurological impairment.	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the detection of convulsive seizures	48 hours
Evaluation of the classification of the background tracing in critical encephalopathy grade	48 hours
Impact of tracing aids on intensivists' confidence level during decision-making	48 hours
Number of suitable anticonvulsant treatments	48 hours
Prescription period for anticonvulsant treatments	48 hours
Hypothermia treatment rates indicated after subsequent rereading of the tracing by the expert	48 hours

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2025
• Primary Completion (Estimated): September 16, 2027
• Study Completion (Estimated): September 16, 2027

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Neonatal encephalopathy; Quantitative neuromonitoring; Pediatric and neonatal critical care
• Other Study ID Numbers: RC24_0381; N° ID-RCB : 2024-A01607-40 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé (ANSM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No