Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 24
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Neuromonitoring with 10 electrodes

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Other outcomes

Sponsors and contacts

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