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Neonatal Neurological Observation With Video AI

NCT07628829 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-07-15

No results posted yet for this 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).

Conditions

  • Neonatal Encephalopathy
  • Hypoxic-Ischemic Encephalopathy
  • Sedation
  • Sleep

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.

Sponsors & Collaborators

  • Artemis AI Labs

    lead INDUSTRY

Principal Investigators

  • Benjamin Glicksberg, PhD · Icahn School of Medicine at Mount Sinai

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-13
Primary Completion
2027-07-12
Completion
2029-07-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628829 on ClinicalTrials.gov