Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring

Recruiting now

Conditions studied: Neonatal Intensive Care Unit

In brief

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.

Key facts

Study ID

NCT06726408

Run by

Nantes University Hospital

People needed

120

Starts

2025-09-16

Expected to finish

2027-09-16

Last updated by the study team

2026-03-10

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• CHU de Nantes — Nantes, France (enrolling)

Full record on ClinicalTrials.gov

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