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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05114070
Acronym
NewbornDS
Enrollment
106
Registered
2021-11-09
Start date
2022-09-08
Completion date
2023-09-08
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalopathy

Keywords

Full Term Newborn, EEG, HIE

Brief 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)

Detailed 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

Interventions

OTHERDecision of hypothermia

Decision of hypothermia thanks to EEG signal

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decision of hypothermia protocol start6 monthsUse of EEG signal in order to develop an algorithm

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026