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Neonatal Neurological Observation With Video AI (NeoNOVA)

1. června 2026 aktualizováno: 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).

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

Over 1.3 million infants are admitted to Neonatal Intensive Care Units (NICUs) in OECD countries every year. All NICU infants undergo cardiorespiratory monitoring allowing for expedient hemodynamic management. However, there is no analogous clinical decision support for neurologic monitoring, despite neurologic injury having the highest impact on long-term neurodevelopmental outcome. Neonatal encephalopathy (NE) is a leading cause of neurodevelopmental impairment (NDI) and death, occurring in 3 per 1000 live births; inadequate pain control and sedation is a leading risk factor for many complications in the NICU including unplanned extubation (UE), occurring at rates 1-5 UEs per 100 intubation days. Currently, neurologic changes such as NE, pain control, and sedation are primarily assessed by physical examination. However, this approach is deeply flawed since physical examination is performed at set time intervals, is highly subjective, and may not discern subtle or subacute changes.

To fill this critical gap in neonatal care, we 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, we can accurately confirm the presence of encephalopathy and quantify the degree of sedation. Our 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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

200

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • New York
      • New York, New York, Spojené státy, 10029
        • Mount Sinai Hospital
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Benjamin Glicksberg, PhD
      • New York, New York, Spojené státy, 10065
        • Weill Cornell Medicine / NewYork-Presbyterian Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Sushma Krishna, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Přístroj: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
AI Anatomic Landmark Tracking Accuracy
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Movement Index - Encephalopathy measured by modified Sarnat exam
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
AI Anatomic Landmark Tracking - Post-Menstrual Age at Video
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Artemis AI Labs

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

31. května 2027

Dokončení studie (Odhadovaný)

31. května 2029

Termíny zápisu do studia

První předloženo

26. května 2026

První předloženo, které splnilo kritéria kontroly kvality

1. června 2026

První zveřejněno (Aktuální)

5. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • STUDY-25-01036

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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