EncephalopathyNewbornDSNCT05114070
Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy
An observational study of Encephalopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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) Read more about this study
- Who is it for?
- Ages Up to 2 days
- Conditions the study is for
- Encephalopathy
- What is being tested?
- Decision of hypothermia
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2022to 8 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 days
- All sexes
- No healthy volunteers
- Child
Study population: Babies born within a context of HIE (Hypoxic Ischemic Encephalopathy)
Who may be able to join
- Full term (> 36 weeks)
- HIE context
- EEG recording before 6 hours of life
Who cannot join
- -Opposition of parental authority holders of a patient born after 2015
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy. NEWBORN NEURO-DIGITAL STUDY
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
- Conditions
- Encephalopathy
- Being tested
- Decision of hypothermia
- Keywords
- Full Term Newborn, EEG, HIE
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision of hypothermiaOther
Decision of hypothermia thanks to EEG signal
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision of hypothermia protocol start
Use of EEG signal in order to develop an algorithm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start8 Sep 2022
- Primary completion8 Sep 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EncephalopathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114070
- Sponsor's protocol ID
- APHP 210070
- Acronym
- NewbornDS
- Status last verified
- Feb 2024
- First submitted
- 9 Jul 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41260106
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy. NEWBORN NEURO-DIGITAL STUDY
- ClinicalTrials.gov ID
- NCT05114070
- Acronym / sponsor ID
- NewbornDS / APHP 210070
- Conditions
- Encephalopathy
- Keywords
- Full Term Newborn, EEG, HIE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies born within a context of HIE (Hypoxic Ischemic Encephalopathy)
Key inclusion criteria (3 listed)
- Full term (> 36 weeks)
- HIE context
- EEG recording before 6 hours of life
Key exclusion criteria (1 listed)
- -Opposition of parental authority holders of a patient born after 2015
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision of hypothermiaDecision of hypothermia thanks to EEG signal | Other | – |
Primary outcome
Decision of hypothermia protocol start
Time frame: 6 months
Use of EEG signal in order to develop an algorithm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 41260106Fiammante 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision of hypothermia protocol start (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05114070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.