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RECRUITING
NCT07628829

Neonatal Neurological Observation With Video AI

Sponsor: Artemis AI Labs

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-07-13

Completion Date

2029-07-12

Last Updated

2026-07-15

Healthy Volunteers

Yes

Interventions

DEVICE

Continuous bedside video monitoring with AI anatomic landmark tracking for neurologic monitoring

A non-contact, passive bedside video recording system is mounted adjacent to the infant's crib or incubator. The device continuously captures video data from enrollment to hospital discharge or withdrawal. The device runs AI models to track infant anatomic landmarks and calculate a continuous movement index. The trial runs in "silent mode," where AI outputs are not shown to the patient's clinical team and do not influence care.

Locations (2)

Mount Sinai Hospital

New York, New York, United States

Weill Cornell Medicine / NewYork-Presbyterian Hospital

New York, New York, United States