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Neonatal Neurological Observation With Video AI (NeoNOVA)

13. juli 2026 oppdatert av: Artemis AI Labs
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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • New York
      • New York, New York, Forente stater, 10029
        • Rekruttering
        • Mount Sinai Hospital
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Benjamin Glicksberg, PhD
      • New York, New York, Forente stater, 10065
        • Har ikke rekruttert ennå
        • Weill Cornell Medicine / NewYork-Presbyterian Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sushma Krishna, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
AI Anatomic Landmark Tracking Accuracy
Tidsramme: At study completion, an average of 1 week.
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.
At study completion, an average of 1 week.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Movement Index - Encephalopathy measured by modified Sarnat exam
Tidsramme: Through study completion, an average of 1 week.
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.
Through study completion, an average of 1 week.
Movement Index - N-PASS
Tidsramme: Through study completion, an average of 1 week.
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.
Through study completion, an average of 1 week.
Movement Index - Sedative Exposure
Tidsramme: Through study completion, an average of 1 week.
Association between movement index and sedative exposure, a routinely collected clinical variable that influences neonatal arousal.
Through study completion, an average of 1 week.
Movement Index - Chronological Age at Video
Tidsramme: Through study completion, an average of 1 week.
Association between movement index and chronological age at video, a routinely collected clinical variable that influences neonatal arousal.
Through study completion, an average of 1 week.
Movement Index - Gestational age at birth
Tidsramme: Through study completion, an average of 1 week.
Association between the movement index and gestational age at birth, a routinely collected clinical variable that influences neonatal arousal.
Through study completion, an average of 1 week.
Movement Index - Sleep state
Tidsramme: Through study completion, an average of 1 week.
Association between the movement index and sleep state, a routinely collected clinical variable that influences neonatal arousal.
Through study completion, an average of 1 week.
Movement Index - EEG evidence of cerebral dysfunction
Tidsramme: Through study completion, an average of 1 week.
Association between the movement index and, if obtained as part of routine clinical care, EEG evidence of cerebral dysfunction (a biomarker of encephalopathy).
Through study completion, an average of 1 week.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
AI Anatomic Landmark Tracking - Post-Menstrual Age at Video
Tidsramme: At study completion, an average of 1 week.
Assess performance of AI anatomic landmark tracking (median position error) across post-menstrual ages at the time of video recording.
At study completion, an average of 1 week.
AI Anatomic Landmark Tracking - Encephalopathy Status
Tidsramme: At study completion, an average of 1 week.
Assess performance of AI anatomic landmark tracking (median position error) across encephalopathy statuses.
At study completion, an average of 1 week.
AI Anatomic Landmark Tracking - Caregiver-reported Race/Ethnicity
Tidsramme: At study completion, an average of 1 week.
Assess performance of AI anatomic landmark tracking (median position error) across caregiver-reported race/ethnicity.
At study completion, an average of 1 week.
AI Anatomic Landmark Tracking - Sex
Tidsramme: At study completion, an average of 1 week.
Assess performance of AI anatomic landmark tracking (median position error) and sex.
At study completion, an average of 1 week.
AI Anatomic Landmark Tracking - Lighting Conditions
Tidsramme: At study completion, an average of 1 week.
Assess performance of AI anatomic landmark tracking (median position error) and lighting conditions (phototherapy, lights on/off, time of day).
At study completion, an average of 1 week.
Parent and Provider Feedback
Tidsramme: At baseline and study completion (Day 1 - Day 7, on average).
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.
At baseline and study completion (Day 1 - Day 7, on average).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Artemis AI Labs

Etterforskere

  • Hovedetterforsker: Benjamin Glicksberg, PhD, Icahn School of Medicine at Mount Sinai

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. juli 2026

Primær fullføring (Antatt)

12. juli 2027

Studiet fullført (Antatt)

12. juli 2029

Datoer for studieregistrering

Først innsendt

26. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY-25-01036

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Aggregate deidentified data and results will be shared. Individual participant video data will not be shared due to PHI concerns.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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