Clinical Trial

Neonatal Neurological Observation With Video AI

Study acronym: NeoNOVA
Recruiting
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).
Protocol Amendment History 3 changes
critical Recruitment opened 2026-07-16
notable Primary completion pushed: 2027-05-31 -> 2027-07-12 2026-07-16
minor Completion pushed: 2029-05-31 -> 2029-07-12 2026-07-16
Trial Details
NCT Number NCT07628829
Lead Sponsor Artemis AI Labs
Conditions Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Sedation, Sleep
Enrollment 200 participants
Start Date 2026-07-13
Primary Completion 2027-07-12 (estimated)
Study Completion 2029-07-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-15