Neonatal Intensive Care UnitCOPeQNCT06726408
Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring
An observational study of Neonatal Intensive Care Unit, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Neonatal Intensive Care Unit
- What is being tested?
- Neuromonitoring with 10 electrodes
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2025to 16 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Noura Zayat, 02.76.64.37.91, noura.zayat@chu-nantes.fr
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Neonatal Intensive Care Unit
- Being tested
- Neuromonitoring with 10 electrodes
- Keywords
- Quantitative neuromonitoring, Pediatric and neonatal critical care, Neonatal encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromonitoring with 10 electrodesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the diagnostic performance of neuromonitoring combining quantitative EEG and possible interpretation by a neurophysiologist in detecting neurological impairment.
Measured: 48 hours
Secondary outcomes (6)
Evaluation of the detection of convulsive seizures
Measured: 48 hours
Evaluation of the classification of the background tracing in critical encephalopathy grade
Measured: 48 hours
Impact of tracing aids on intensivists' confidence level during decision-making
Measured: 48 hours
Number of suitable anticonvulsant treatments
Measured: 48 hours
Prescription period for anticonvulsant treatments
Measured: 48 hours
Hypothermia treatment rates indicated after subsequent rereading of the tracing by the expert
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start16 Sep 2025
- Primary completion16 Sep 2027 (estimated)
- Study completion16 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726408
- Sponsor's protocol ID
- RC24_0381
- Other IDs
- N° ID-RCB : 2024-A01607-40
- Acronym
- COPeQ
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Care Optimized Pediatric Quantitative EEG
- ClinicalTrials.gov ID
- NCT06726408
- Acronym / sponsor ID
- COPeQ / RC24_0381
- Conditions
- Neonatal Intensive Care Unit
- Keywords
- Quantitative neuromonitoring, Pediatric and neonatal critical care, Neonatal encephalopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 16 Sep 2027 (estimated)
- Study completion
- 16 Sep 2027 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromonitoring with 10 electrodesIn 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. | Other | – |
Primary outcome
Evaluate the diagnostic performance of neuromonitoring combining quantitative EEG and possible interpretation by a neurophysiologist in detecting neurological impairment.
Time frame: 48 hours
6 secondary outcomes
Evaluation of the detection of convulsive seizures
Time frame: 48 hours
Evaluation of the classification of the background tracing in critical encephalopathy grade
Time frame: 48 hours
Impact of tracing aids on intensivists' confidence level during decision-making
Time frame: 48 hours
Number of suitable anticonvulsant treatments
Time frame: 48 hours
Prescription period for anticonvulsant treatments
Time frame: 48 hours
Hypothermia treatment rates indicated after subsequent rereading of the tracing by the expert
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Intensive Care Unit, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noura ZAYAT, PH (33 2 76 64 37 91, noura.zayat@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the diagnostic performance of neuromonitoring combining quantitative EEG and possible interpretation by a neurophysiologist in detecting neurological impairment. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.