Neonatal Neurological Observation With Video AI
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorArtemis AI Labs
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Parents or LAR unable to provide informed consent or are under the age of 18.
Non-viable neonates
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Continuous bedside video monitoring with AI anatomic landmark tracking for neurologic monitoring
DeviceA 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: NICU-Admitted Infants Undergoing Continuous Video Monitoring1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Other outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov