Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring

NCT06726408 | Recruiting

• 2 other identifiers: RC24_0381N° ID-RCB : 2024-A01607-40
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Intensive Care Unit

Keywords

Quantitative neuromonitoring; Pediatric and neonatal critical care; Neonatal encephalopathy

Outcome Measures

Primary Outcomes (1)

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

  48 hours

Secondary Outcomes (6)

• 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

Interventions

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.

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

RECRUITING

Central Study Contacts

Noura ZAYAT, PH

CONTACT

33 2 76 64 37 91; noura.zayat@chu-nantes.fr

Pierre BOURGOIN, PH

CONTACT

33 2 76 64 36 12; pierre.bourgoin@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 10, 2024
• Study Start: September 16, 2025
• Primary Completion (Estimated): September 16, 2027
• Study Completion (Estimated): September 16, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-01

Locations

FR (1)