Hypoxic-Ischemic EncephalopathyCOOLDECIDENCT07764315
EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns
An observational study of Hypoxic-Ischemic Encephalopathy and Perinatal Asphyxia, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
This retrospective, multicenter, observational study evaluates how well a decision-support algorithm can tell apart mild forms of hypoxic-ischemic encephalopathy (HIE) from moderate or severe forms in full-term newborns born after a lack of oxygen around birth (perinatal asphyxia). Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia, Neonatal Brain Injury
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2026to 16 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: Term newborns ≥ 36 weeks gestational age, birth weight ≥ 1800 g, with suspected hypoxic-ischemic encephalopathy in a context of perinatal asphyxia, whose non-compressed conventional EEG recordings are available in participating centers.
Who may be able to join
- No parental opposition to the use of the child's medical data within 1 month of the mailed information notice
- Gestational age ≥ 36 weeks of amenorrhea
- Birth weight ≥ 1800 g
- Born in a context of perinatal asphyxia (any cause) leading to suspected HIE, with EITHER biological signs of metabolic acidosis (pH ≤ 7 or base deficit ≥ 16 mmol/L or lactate ≥ 11 mmol/L within the first hour of life, any blood sample) OR a history of asphyxia with Apgar ≤ 5 at 10 minutes or need for ventilatory resuscitation continued at 10 minutes of life
- Non-compressed conventional EEG (EEGc) recorded before the 6th hour of life
- EEG including the signal of active electrodes Fp1, Fp2, T3 and T4
Who cannot join
- Participation in a therapeutic biomedical research liable to modify the EEG tracing
- Fewer than 20 minutes of artifact-free EEG recording
- Signal from active electrodes Fp1, Fp2, T3 and T4 not exploitable
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Retrospective Multicenter Validation of a Conventional EEG-Based Decision-Support Algorithm to Discriminate Mild Versus Moderate/Severe Hypoxic-Ischemic Encephalopathy in Term Newborns (Newborn Neuro Digital Project)
This retrospective, multicenter, observational study evaluates how well a decision-support algorithm can tell apart mild forms of hypoxic-ischemic encephalopathy (HIE) from moderate or severe forms in full-term newborns born after a lack of oxygen around birth (perinatal asphyxia). The algorithm reads the raw (non-compressed) EEG signal. Its output is compared with the reference reading of the full conventional EEG made by a panel of pediatric neurophysiologists together with the baby's clinical information. The study uses only medical data that already exists and asks nothing of the babies or their families.
Read the detailed description
The algorithm under investigation was developed in a previous retrospective clinical study (registered as NCT05114070; French CNIL/ethics ref CER-2021-023; approved by the Sorbonne University ethics committee) and is based on background-rhythm analysis of EEG. Newborns are analyzed in two subgroups: those who received a treatment liable to modify the EEG tracing, and those who did not. Conventional EEG recordings are collected from the neurophysiology departments of participating level-3 maternity hospitals over the period 01 January 2016 to 30 April 2026. No follow-up or sampling is performed.
- Keywords
- conventional EEG, therapeutic hypothermia, decision-support software, term newborn, diagnostic accuracy, medical device software
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Term newborns with suspected HIE | Single study population: term newborns (≥ 36 weeks, ≥ 1800 g) with suspected hypoxic-ischemic encephalopathy in a context of perinatal asphyxia, with an available non-compressed conventional EEG. This is a diagnostic-accuracy validation study (STARD), not a comparative two-arm design. The treated / untreated distinction is a pre-specified analysis subgroup only, not a study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the algorithm versus the gold standard for discriminating mild vs moderate/severe HIE
Diagnostic performance computed against the reference EEG reading by pediatric neurophysiologists complemented by clinical data; 95% confidence intervals by the exact (Clopper-Pearson) method.
Measured: Within the first 6 hours of life
Secondary outcomes (3)
PPV, NPV, false-alarm ratio, accuracy, balanced accuracy and F1-score of the algorithm vs gold standard (overall and by subgroup)
Secondary diagnostic-performance metrics computed overall and within the treated / untreated subgroups.
Measured: Within the first 6 hours of life
Proportion of transfers not leading to therapeutic hypothermia
Share of included newborns not treated by therapeutic hypothermia at the time, including those transferred from a level 1/2a/2b maternity or managed within the same facility.
Measured: During the initial hospitalization (up to 28 days of life)
Evaluate the inter-rater agreement between the first two expert neurophysiologists
Inter-rater agreement will be assessed using Cohen's kappa coefficient (κ), with a 95% confidence interval.
Measured: EEG recordings from the first 6 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start16 Sep 2026 (estimated)
- Primary completion16 Jan 2027 (estimated)
- Study completion16 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- BPI
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764315
- Sponsor's protocol ID
- APHP261081
- Acronym
- COOLDECIDE
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: AP-HP is the sole owner of the data. Individual participant data are not planned to be shared; any use or transmission to a third party requires the sponsor's prior authorization, under conditions ensuring confidentiality and a level of protection equivalent to EU legislation.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multicenter Validation of a Conventional EEG-Based Decision-Support Algorithm to Discriminate Mild Versus Moderate/Severe Hypoxic-Ischemic Encephalopathy in Term Newborns (Newborn Neuro Digital Project)
- ClinicalTrials.gov ID
- NCT07764315
- Acronym / sponsor ID
- COOLDECIDE / APHP261081
- Keywords
- conventional EEG, therapeutic hypothermia, decision-support software, term newborn, diagnostic accuracy, medical device software
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- BPI
- Study start
- 16 Sep 2026 (estimated)
- Primary completion
- 16 Jan 2027 (estimated)
- Study completion
- 16 Feb 2027 (estimated)
- First posted
- 13 Aug 2026 (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.
This retrospective, multicenter, observational study evaluates how well a decision-support algorithm can tell apart mild forms of hypoxic-ischemic encephalopathy (HIE) from moderate or severe forms in full-term newborns born after a lack of oxygen around birth (perinatal asphyxia). The algorithm reads the raw (non-compressed) EEG signal. Its output is compared with the reference reading of the full conventional EEG made by a panel of pediatric neurophysiologists together with the baby's clinical information. The study uses only medical data that already exists and asks nothing of the babies or their families.
Detailed description
The algorithm under investigation was developed in a previous retrospective clinical study (registered as NCT05114070; French CNIL/ethics ref CER-2021-023; approved by the Sorbonne University ethics committee) and is based on background-rhythm analysis of EEG. Newborns are analyzed in two subgroups: those who received a treatment liable to modify the EEG tracing, and those who did not. Conventional EEG recordings are collected from the neurophysiology departments of participating level-3 maternity hospitals over the period 01 January 2016 to 30 April 2026. No follow-up or sampling is performed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Term newborns with suspected HIE | – | –Single study population: term newborns (≥ 36 weeks, ≥ 1800 g) with suspected hypoxic-ischemic encephalopathy in a context of perinatal asphyxia, with an available non-compressed conventional EEG. This is a diagnostic-accuracy validation study (STARD), not a comparative two-arm design. The treated / untreated distinction is a pre-specified analysis subgroup only, not a study group. |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term newborns ≥ 36 weeks gestational age, birth weight ≥ 1800 g, with suspected hypoxic-ischemic encephalopathy in a context of perinatal asphyxia, whose non-compressed conventional EEG recordings are available in participating centers.
Key inclusion criteria (6 listed)
- No parental opposition to the use of the child's medical data within 1 month of the mailed information notice
- Gestational age ≥ 36 weeks of amenorrhea
- Birth weight ≥ 1800 g
- Born in a context of perinatal asphyxia (any cause) leading to suspected HIE, with EITHER biological signs of metabolic acidosis (pH ≤ 7 or base deficit ≥ 16 mmol/L or lactate ≥ 11 mmol/L within the first hour of life, any blood sample) OR a history of asphyxia with Apgar ≤ 5 at 10 minutes or need for ventilatory resuscitation continued at 10 minutes of life
- Non-compressed conventional EEG (EEGc) recorded before the 6th hour of life
Key exclusion criteria (3 listed)
- Participation in a therapeutic biomedical research liable to modify the EEG tracing
- Fewer than 20 minutes of artifact-free EEG recording
- Signal from active electrodes Fp1, Fp2, T3 and T4 not exploitable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of the algorithm versus the gold standard for discriminating mild vs moderate/severe HIE
Time frame: Within the first 6 hours of life
Diagnostic performance computed against the reference EEG reading by pediatric neurophysiologists complemented by clinical data; 95% confidence intervals by the exact (Clopper-Pearson) method.
3 secondary outcomes
PPV, NPV, false-alarm ratio, accuracy, balanced accuracy and F1-score of the algorithm vs gold standard (overall and by subgroup)
Time frame: Within the first 6 hours of life
Proportion of transfers not leading to therapeutic hypothermia
Time frame: During the initial hospitalization (up to 28 days of life)
Evaluate the inter-rater agreement between the first two expert neurophysiologists
Time frame: EEG recordings from the first 6 hours of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. AP-HP is the sole owner of the data. Individual participant data are not planned to be shared; any use or transmission to a third party requires the sponsor's prior authorization, under conditions ensuring confidentiality and a level of protection equivalent to EU legislation.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic-Ischemic Encephalopathy and Perinatal Asphyxia, run by Assistance Publique - Hôpitaux de Paris.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde LETOUZEY, M.D (+ 33171738599, mathilde.letouzey@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the algorithm versus the gold standard for discriminating mild vs moderate/severe HIE (time frame: Within the first 6 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.