Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring

Not yet recruiting

• Conditions: Neonatal Intensive Care Unit

• Registration Number: NCT06726408
• Lead Sponsor: Nantes University Hospital

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. ...

Detailed Description

This research will take place in three phases :

1. 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.

2. Teams' training regarding the placement of additional electrodes and the use of reading aid tools.
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Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-11-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Study Start: 2025-01-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the diagnostic performance of neuromonitoring combining quantitative EEG and possible interpretation by a neurophysiologist in detecting neurological impairment.	48 hours