Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring

NCT ID: NCT06726408

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-16
• Study Completion Date: 2026-09-16

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.

Conditions

Neonatal Intensive Care Unit

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Neuromonitoring with 10 electrodes

In case of no parental objection, the clinician may begin neuromonitoring according to standard indications. The number of electrodes applied to the child's skull will be 10 electrodes (8 recording electrodes, 1 reference electrode, and 1 ground electrode) instead of the current 5.

The intensivist will analyze the quantitative EEG trace as they currently do but will also have access to additional tools for seizure detection support (CDSA and seizure detection software) and targeted review of part of the recording by a neurophysiologist in case of doubt. Access to the neurophysiologist will be available during current working hours on weekdays. Data will be collected in 12-hour periods.

Intervention Type: OTHER

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.

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nantes

Nantes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Noura ZAYAT, PH

Role: CONTACT

noura.zayat@chu-nantes.fr

33 2 76 64 37 91

Pierre BOURGOIN, PH

Role: CONTACT

pierre.bourgoin@chu-nantes.fr

33 2 76 64 36 12

Facility Contacts

Noura Zayat

Role: primary

noura.zayat@chu-nantes.fr

02.76.64.37.91

Other Identifiers

N° ID-RCB : 2024-A01607-40

Identifier Type: OTHER

Identifier Source: secondary_id

RC24_0381

Identifier Type: -

Identifier Source: org_study_id