Recruiting

Observational Study

Sponsor:

Artemis AI Labs

Code:

NCT07628829

Conditions

Neonatal Encephalopathy

Hypoxic-Ischemic Encephalopathy

Sedation

Sleep

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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

Study ID

NCT07628829

Start date

Jul 13, 2026

Status verified date

Jul, 2026

Completion date

Jul 12, 2029

Anticipated

Primary completion date

Jul 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

NICU-Admitted Infants Undergoing Continuous Video Monitoring

Infants admitted to newborn services, including the neonatal intensive care unit (NICU), who meet eligibility criteria and undergo continuous, non-contact bedside video monitoring from enrollment until hospital discharge.

Interventions

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.

Primary outcome measure

  • AI Anatomic Landmark Tracking Accuracy [ Time Frame: At study completion, an average of 1 week. ]

Central Contacts and Locations

Central contacts

Saum Naderi, MA

714-913-3641saum@artemisailabs.com

Florian Richter, PhD

773-312-3301florian@artemisailabs.com

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Klaren Ng

347-525-8336klaren.ng@mssm.edu

Rachelle Weisman, MPH

rachelle.weisman@mssm.edu

Principal Investigator:

Benjamin Glicksberg, PhD

More Information

Sponsor

Artemis AI Labs

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • Pose AI
  • Neonatal
  • Neonate
  • AI
  • Video AI
  • artificial intelligence
  • computer vision
  • NICU
  • Encephalopathy
  • Sedation
  • neonatal monitoring
  • movement analysis
  • pose estimation
  • machine learning
  • neurological assessment
  • spontaneous movement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Artemis AI Labs on 2026-07-15.