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OpenTrials
Completed

NCT Number: NCT05114070

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

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)

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Key information

Conditions

Encephalopathy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

Up to 2 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital TROUSSEAU

Paris, 75012, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision of hypothermia

Other

Decision of hypothermia thanks to EEG signal

Primary outcomes

  1. Decision of hypothermia protocol start

    Time frame: 6 months

    Use of EEG signal in order to develop an algorithm

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: NewbornDS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2021
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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