AI camera watches newborns' brains—no wires, no touch
NCT ID NCT07628829
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
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Mount Sinai Hospital
RECRUITINGNew York, New York, 10029, United States
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Weill Cornell Medicine / NewYork-Presbyterian Hospital
NOT_YET_RECRUITINGNew York, New York, 10065, United States
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