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NCT05114070 Clinical Trial

Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy

Encephalopathy Clinical Trial

— NewbornDS  

Official title:
Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy. NEWBORN NEURO-DIGITAL STUDY

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05114070
Other study ID # APHP 210070
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 8, 2022
Est. completion date September 8, 2023

Study information
Verified date February 2024
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The project aims at designing a machine learning solution able to recognize characteristics signals patterns of brain damages in full term babies born within a context of Hypoxic Ischemic Encephalopathy (HIE)

Description:

Retrospective study based on a digital EEG signal library intending to design, train and test an efficient AI solution for hypothermia protocol start indications. The output of the Project is to make available to pediatric resuscitation units an adequate tool to guide them in the decision of hypothermia protocol start in a general context of neurophysiologist competence scarcity. EEG signal that would allow the algorithm design will be based on several parameters of the conventional EEG and not only on signal amplitude

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date September 8, 2023
Est. primary completion date September 8, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Days
Eligibility Inclusion Criteria: - Full term (> 36 weeks) - HIE context - EEG recording before 6 hours of life Exclusion Criteria: -Opposition of parental authority holders of a patient born after 2015

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Decision of hypothermia
Decision of hypothermia thanks to EEG signal

Locations
Country Name City State
France Hôpital TROUSSEAU Paris

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decision of hypothermia protocol start Use of EEG signal in order to develop an algorithm 6 months
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