Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Neonatal Neurological Observation With Video AI (NeoNOVA)

13 de julho de 2026 atualizado por: 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).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

200

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • New York
      • New York, New York, Estados Unidos, 10029
        • Recrutamento
        • Mount Sinai Hospital
        • Contato:
        • Contato:
        • Investigador principal:
          • Benjamin Glicksberg, PhD
      • New York, New York, Estados Unidos, 10065
        • Ainda não está recrutando
        • Weill Cornell Medicine / NewYork-Presbyterian Hospital
        • Contato:
        • Investigador principal:
          • Sushma Krishna, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
AI Anatomic Landmark Tracking Accuracy
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Movement Index - Encephalopathy measured by modified Sarnat exam
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
AI Anatomic Landmark Tracking - Post-Menstrual Age at Video
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Artemis AI Labs

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

13 de julho de 2026

Conclusão Primária (Estimado)

12 de julho de 2027

Conclusão do estudo (Estimado)

12 de julho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

26 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de junho de 2026

Primeira postagem (Real)

5 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STUDY-25-01036

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever