Actively Recruiting

Age: 0 - 24Months
All Genders
NCT06726408

Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring

Led by Nantes University Hospital · Updated on 2026-03-10

120

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring

Who Can Participate

Age: 0 - 24Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring
  • Written non-opposition from legal representatives
  • Patients affiliated with or beneficiaries of a social security or similar scheme (CMU)
Not Eligible

You will not qualify if you...

  • Parents who do not understand French
  • Inability to set up monitoring equipment due to neurosurgery preventing electrode placement
  • Corrected age less than 37 weeks of gestation for preterm infants

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU de Nantes

Nantes, France, 44093

Actively Recruiting

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Research Team

N

Noura ZAYAT, PH

CONTACT

P

Pierre BOURGOIN, PH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring | DecenTrialz