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NCT Number: NCT06726408

Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring

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.

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Key information

Conditions

Neonatal Intensive Care Unit

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This research will take place in three phases :

  • 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.
  • Teams' training regarding the placement of additional electrodes and the use of reading aid tools.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuromonitoring with 10 electrodes

Other

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.

Primary outcomes

  1. Evaluate the diagnostic performance of neuromonitoring combining quantitative EEG and possible interpretation by a neurophysiologist in detecting neurological impairment.

    Time frame: 48 hours

Secondary outcomes

  1. Evaluation of the detection of convulsive seizures

    Time frame: 48 hours

  2. Evaluation of the classification of the background tracing in critical encephalopathy grade

    Time frame: 48 hours

  3. Impact of tracing aids on intensivists' confidence level during decision-making

    Time frame: 48 hours

  4. Number of suitable anticonvulsant treatments

    Time frame: 48 hours

  5. Prescription period for anticonvulsant treatments

    Time frame: 48 hours

  6. Hypothermia treatment rates indicated after subsequent rereading of the tracing by the expert

    Time frame: 48 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Noura ZAYAT, PH

CONTACT

[email protected]

33 2 76 64 37 91

Pierre BOURGOIN, PH

CONTACT

[email protected]

33 2 76 64 36 12

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Critical Care Optimized Pediatric Quantitative EEG

Acronym: COPeQ

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 10, 2024
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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