Neonatal Neurological Observation With Video AI
Purpose
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
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Artemis AI Labs
Detailed Description
To fill this critical gap in neonatal care, the investigators developed and validated NeoPose, a low-cost, non-invasive, computer vision digital health tool to continuously monitor infants using real time video streams. NeoPose uses Pose Artificial Intelligence (AI) for an explainable approach to measure, quantify, and analyze infant movement. From the vectorized movement, investigators can accurately confirm the presence of encephalopathy and quantify the degree of sedation. The explainable AI platform enables continuous neuromonitoring with AI-driven alerts, suspicious event replay, movement comparisons, and training on a vast dataset of normal and abnormal infant movements far beyond what any provider could witness. The Neonatal Neurological Observation with Video AI (NeoNOVA) study is a multi-site, prospective, single-arm, pragmatic, silent observational study to evaluate the performance of NeoPose and AI-derived insights in real world settings. NeoNOVA will deploy a bedside video monitoring system (ArtemisAI Platform) that continuously, passively video records the subject from enrollment to discharge. The study will prospectively validate the AI system's tracking accuracy against ground-truth human-labeled video frames (primary objective; outcome median position error in pixels), will evaluate the association between a video-derived movement index and standardized bedside assessments of encephalopathy, pain, and sedation (secondary objective; outcomes N-PASS and modified Sarnat scales), and will support hypothesis-generating research on novel video prediction algorithms for outcomes like sepsis and need for respiratory support (tertiary objective). The study operates in "silent mode," where AI outputs are not shown to the patient's clinical team. Findings are intended to support a structured clinical evidence generation plan for a Software as a Medical Device (SaMD) designed for continuous, non-contact neurological monitoring in the NICU.