Neonatal Neurological Observation With Video AI (NCT07628829) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neonatal Neurological Observation With Video AI
United States200 participantsStarted 2026-06-01
Plain-language summary
NeoNOVA is a multi-site, prospective, single-arm, silent observational study to determine: among (Population) infants admitted to newborn services during their inpatient hospital stay, whether (Intervention) continuous bedside non-contact high definition video running real-time AI analysis of anatomic landmarks and movement, (Comparison) compared against human-labeled video frames and standardized clinical exams, will (Outcome) accurately localize infant anatomic landmarks (primary objective; outcome median position error in pixels) and demonstrate a statistically significant association between a video-derived movement index and clinical measures of patient neurological exams (secondary objective; outcomes N-PASS and modified Sarnat exams).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AI Anatomic Landmark Tracking Accuracy
Timeframe: At study completion, an average of 1 week.