Neonatal Neurological Observation With Video AI

ID#: NCT07628829

Age: Birth - 66+

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Recruitment Status: Recruiting

Start Date: July 13, 2026

End Date: July 12, 2029

Contact Information:
Saum Naderi, MA
714-913-3641
Florian Richter, PhD
773-312-3301
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).
Eligibility:

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
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