Neonatal Neurological Observation With Video AI
Trial statusNot yet recruiting
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
Qualifiers
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 design
Treatments tested in this trial
- Continuous bedside video monitoring with AI anatomic landmark tracking for neurologic monitoring
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov