An observational study in Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy and Sedation, sponsored by Artemis AI Labs. Recruiting at 2 sites in United States. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Artemis AI Labs · Observational
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).
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.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 95 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 92 observational studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →This is the only study on the registry with Artemis AI Labs as lead sponsor.
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Neonates of any sex, gestational age, demographic background, or health status admitted to newborn services, including the NICU, at a participating hospital. No diagnosis-specific criteria apply. Consent is provided by at least one parent or legally authorized representative aged 18 or older. Sites will make reasonable efforts to enroll a demographically diverse sample reflective of their local NICU populations, supporting prespecified subgroup analyses of AI performance consistency across gestational age, race/ethnicity, sex, and clinical condition. The first five participants at each site are excluded from primary and secondary endpoint analyses and serve as a technology familiarization cohort.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
AI Anatomic Landmark Tracking Accuracy
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.
Time frame: At study completion, an average of 1 week.
Movement Index - Encephalopathy measured by modified Sarnat exam
Association between a video-derived movement index and encephalopathy classification of severity from the modified Sarnat exam score, a bedside neurological exam assessed by trained clinical staff.
Time frame: Through study completion, an average of 1 week.
Movement Index - N-PASS
Association between a video-derived movement index and Neonatal Pain, Agitation, and Sedation Scale (N-PASS) score (ordinal outcome), a bedside neurological exam measuring pain/sedation and assessed by trained clinical staff.
Time frame: Through study completion, an average of 1 week.
Movement Index - Sedative Exposure
Association between movement index and sedative exposure, a routinely collected clinical variable that influences neonatal arousal.
Time frame: Through study completion, an average of 1 week.
Movement Index - Chronological Age at Video
Association between movement index and chronological age at video, a routinely collected clinical variable that influences neonatal arousal.
Time frame: Through study completion, an average of 1 week.
Movement Index - Gestational age at birth
Association between the movement index and gestational age at birth, a routinely collected clinical variable that influences neonatal arousal.
Time frame: Through study completion, an average of 1 week.
Movement Index - Sleep state
Association between the movement index and sleep state, a routinely collected clinical variable that influences neonatal arousal.
Time frame: Through study completion, an average of 1 week.
Movement Index - EEG evidence of cerebral dysfunction
Association between the movement index and, if obtained as part of routine clinical care, EEG evidence of cerebral dysfunction (a biomarker of encephalopathy).
Time frame: Through study completion, an average of 1 week.
AI Anatomic Landmark Tracking - Post-Menstrual Age at Video
Assess performance of AI anatomic landmark tracking (median position error) across post-menstrual ages at the time of video recording.
Time frame: At study completion, an average of 1 week.
AI Anatomic Landmark Tracking - Encephalopathy Status
Assess performance of AI anatomic landmark tracking (median position error) across encephalopathy statuses.
Time frame: At study completion, an average of 1 week.
AI Anatomic Landmark Tracking - Caregiver-reported Race/Ethnicity
Assess performance of AI anatomic landmark tracking (median position error) across caregiver-reported race/ethnicity.
Time frame: At study completion, an average of 1 week.
AI Anatomic Landmark Tracking - Sex
Assess performance of AI anatomic landmark tracking (median position error) and sex.
Time frame: At study completion, an average of 1 week.
AI Anatomic Landmark Tracking - Lighting Conditions
Assess performance of AI anatomic landmark tracking (median position error) and lighting conditions (phototherapy, lights on/off, time of day).
Time frame: At study completion, an average of 1 week.
Parent and Provider Feedback
Brief structured surveys administered to parents and clinical providers to assess acceptability, usability, and perceived burden of the bedside video monitoring system. Findings will inform system design refinements and support future bedside adoption and regulatory human factors documentation.
Time frame: At baseline and study completion (Day 1 - Day 7, on average).
Plan to share: No — Aggregate deidentified data and results will be shared. Individual participant video data will not be shared due to PHI concerns.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 11 months after the start.
Of 51 observational studies under Hypoxia-Ischemia, Brain, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
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