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AI camera watches newborns' brains—no wires, no touch

NCT ID NCT07628829

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study tests whether a video camera with artificial intelligence can track newborn brain health by analyzing their movements. About 200 babies in the NICU will be recorded continuously from admission to discharge. The AI's findings are kept from doctors for now, to see if the technology can match standard exams. If it works, it could offer a hands-free way to monitor brain problems in fragile infants.

What this could mean

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

Active substance
Continuous bedside video monitoring with AI anatomic landmark tracking
What this could lead to
If successful, this could lead to a non-contact way to monitor brain health in newborns, potentially catching issues earlier without disturbing the baby.
What could go wrong
This is an early observational study, so it only tests if the AI works—not if it improves outcomes. The AI results are hidden from doctors, so no direct benefit to participants.

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 200 people

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

Started

Jul 2026

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Neonates of any sex, gestational age, demographic background, or health status admitted to newborn services, including the NICU, at a participating hospital. No diagnosis-specific criteria apply. Consent is provided by at least one parent or legally authorized representative aged 18 or older. Sites will make reasonable efforts to enroll a demographically diverse sample reflective of their local NICU populations, supporting prespecified subgroup analyses of AI performance consistency across gestational age, race/ethnicity, sex, and clinical condition. The first five participants at each site are excluded from primary and secondary endpoint analyses and serve as a technology familiarization cohort.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Signed and dated informed consent from at least one parent or legally authorized representative (LAR) who is at least 18 years old. * Parent/LAR expresses willingness to comply with study procedures for the duration of the infant's hospital stay. * Infant of any sex (including intersex/undetermined) admitted to newborn services (including the NICU) at a participating hospital. Exclusion Criteria: * Parents or LAR unable to provide informed consent or are under the age of 18. * Non-viable neonates

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Weill Cornell Medicine / NewYork-Presbyterian Hospital

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

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