Neonatal Neurological Observation With Video AI

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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).

Eligibility

Primary outcome measure(s)

• AI Anatomic Landmark Tracking Accuracy — At study completion, an average of 1 week.
  The primary endpoint is analytical performance of the AI pose estimation system, quantified as median position error (in pixels) between AI-predicted and human-labeled anatomic landmark positions extracted from continuous bedside video. Success is defined as median position error less than typical human inter-rater variability.

Trial sites (2)

Other trials for the same condition