Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy
NewbornDS
1 other identifier
observational
106
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2021
CompletedFirst Posted
Study publicly available on registry
November 9, 2021
CompletedStudy Start
First participant enrolled
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2023
CompletedFebruary 5, 2024
February 1, 2024
1 year
July 9, 2021
February 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decision of hypothermia protocol start
Use of EEG signal in order to develop an algorithm
6 months
Interventions
Decision of hypothermia thanks to EEG signal
Eligibility Criteria
Babies born within a context of HIE (Hypoxic Ischemic Encephalopathy)
You may qualify if:
- Full term (\> 36 weeks)
- HIE context
- EEG recording before 6 hours of life
You may not qualify if:
- Opposition of parental authority holders of a patient born after 2015
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital TROUSSEAU
Paris, 75012, France
Related Publications (1)
Fiammante M, Vermersch AI, Vidailhet M, Chavez M. A simple EEG-based tool to guide therapeutic hypothermia decisions in neonatal hypoxic-ischemic encephalopathy. Comput Methods Programs Biomed. 2026 Feb 1;274:109166. doi: 10.1016/j.cmpb.2025.109166. Epub 2025 Nov 13.
PMID: 41260106DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2021
First Posted
November 9, 2021
Study Start
September 8, 2022
Primary Completion
September 8, 2023
Study Completion
September 8, 2023
Last Updated
February 5, 2024
Record last verified: 2024-02