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CompletedNCT05114070NewbornDSUpdated Feb 5, 2024

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

An observational study in Encephalopathy, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged Up to 2 Days. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
106
Ages
Up to 2 Days
Sex
All
01

Study 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)

Read the 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

02

Conditions studied

  • Encephalopathy

Keywords

  • Full Term Newborn
  • EEG
  • HIE
03

In context

Brain Diseases

758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.

This study's enrollment of 106 is close to the median of 100 across 265 observational studies indexed under Brain Diseases.

Browse Brain Diseases studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 2 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Babies born within a context of HIE (Hypoxic Ischemic Encephalopathy)

Inclusion criteria

  • Full term (> 36 weeks)
  • HIE context
  • EEG recording before 6 hours of life

Exclusion criteria

Exclusion Criteria:

-Opposition of parental authority holders of a patient born after 2015

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
106 participants (actual)
Patient registry
No

Interventions

  • OtherDecision of hypothermia

    Decision of hypothermia thanks to EEG signal

06

What researchers measure

Primary outcomes

  1. Decision of hypothermia protocol start

    Use of EEG signal in order to develop an algorithm

    Time frame: 6 months

07

Study locations

1 site
  • Hôpital TROUSSEAU
    Paris, 75012, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05114070
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Nov 9, 2021
Start date
Sep 8, 2022
Primary completion
Sep 8, 2023
Completion
Sep 8, 2023
Last update
Feb 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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