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Brain-Wave algorithm may flag newborns needing urgent cooling

NCT ID NCT07764315

Diagnosis Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study tests whether a computer algorithm can analyze standard EEG recordings from full-term newborns who experienced oxygen deprivation at birth to tell apart mild brain injury from moderate or severe forms. The algorithm's readings are compared against expert review of the full EEG plus clinical information. The study uses only existing medical data from 310 babies, requiring no extra procedures or visits. If the algorithm proves reliable, it could help doctors make faster, more objective decisions about which newborns need therapeutic hypothermia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A decision-support algorithm that analyzes conventional EEG signals to classify the severity of hypoxic-ischemic encephalopathy in newborns.
What this could lead to
If accurate, this algorithm could help doctors quickly and objectively identify which newborns need intensive cooling therapy, potentially improving outcomes for babies with brain injury.
What could go wrong
This is a retrospective observational study, so the algorithm's real-world performance may differ. It also relies on existing data, which may have gaps or biases, and the algorithm's accuracy needs confirmation in prospective trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 310 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

0 days to 1 day

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypoxic-ischemic encephalopathy Neonatal brain injury Perinatal asphyxia

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.