Trials Sponsors Conditions Drugs Pricing

Conditions

Dysphagia of Newborn

Outcome Measures

Primary Outcomes (2)

Correlation between NOMAS evaluation and AI analysis of dysphagia
Correlation between NOMAS evaluation and AI analysis of dysphagia
up to 2 years
Correlation between VFSS evaluation and AI analysis of dysphagia
Correlation between VFSS evaluation and AI analysis of dysphagia
up to 2 years

Secondary Outcomes (1)

Correlation between AI analysis of dysphagia and development
up to 2 years

Study Arms (1)

Infant with suspected dysphagia

OTHER

For newborns and infants who satisfy the inclusion and exclusion criteria, after taking a video of a bottle feeding, we try to develop an evaluation of swallowing disorder through artificial intelligence-based analysis. The developed evaluation will be verified for validity by comparing it with NOMAS (and VFSS if possible), and the correlation with future development will be analyzed through the relationship with the 1st and 2nd year correctional Bailey Developmental Evaluation.

Diagnostic Test: AI analysis

Interventions

AI analysisDiagnostic test

1. Bottle feeding filming \- With a camera that can measure depth, take a video of feeding milk from a bottle for 5-10 minutes. 2. NOMAS (Neonatal Oral-Motor Assessment Scale) evaluation * Evaluate NOMAS with bottle feeding video by certified evaluators. * NOMAS, developed by Marjorie Meyer Palmer in 1983, is an evaluation method for dysphagia applicable to infants under 48 weeks of PMA. 3. Implementation of video analysis using deep learning (A) Analysis method - Implement a deep learning network that sets keypoints of faces and environments related to swallowing and detects specified keypoints in units of frames. (B) Analyze the movement of key points, and figure out the correlation between swallowing states. (C) Create an input/output process that can automatically classify swallowing states with video as input.

Infant with suspected dysphagia

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Eligibility Criteria

AgeUp to 6 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Newborns and infants under 6 months of correctional age
Clinically suspected to have dysphagia

Sponsors & Collaborators

Asan Medical Center
Otherlead

Study Sites (1)

Asan medical Center

Seoul, 05505, South Korea

RECRUITING

CONTACT1688-7575

Central Study Contacts

Eunjae Ko, M.D.

CONTACT

010-9988-6285 gonjae0610@gmail.com

Garam Hong, M.D.

CONTACT

010-9146-7738

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director, Principal investigator, Resident of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 24, 2022

Study Start

August 2, 2021

Actual (reported)

Primary Completion

December 31, 2024

Estimated (date passed)

Development of Dysphagia Evaluation Via Video Analysis Based on Deep Learning Method in Neonates and Infants and Correlation Between the Evaluation and the Development

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Infant with suspected dysphagia

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Infant with suspected dysphagia

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations