Development of Dysphagia Evaluation Via Video Analysis Based on Deep Learning Method in Neonates and Infants and Correlation Between the Evaluation and the Development
Primary Purpose
Dysphagia of Newborn
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AI analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Dysphagia of Newborn
Eligibility Criteria
Inclusion Criteria:
- Newborns and infants under 6 months of correctional age
- Clinically suspected to have dysphagia
- In case parental consent is obtained
Exclusion Criteria:
- In case of cardiopulmonary instability (ECMO, Ventilator, etc. are being applied)
- When it is not possible to secure sufficient fields for artificial intelligence analysis of images due to factors such as anatomical abnormalities of the head and neck
Sites / Locations
- Asan medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Infant with suspected dysphagia
Arm Description
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.
Outcomes
Primary Outcome Measures
Correlation between NOMAS evaluation and AI analysis of dysphagia
Correlation between NOMAS evaluation and AI analysis of dysphagia
Correlation between VFSS evaluation and AI analysis of dysphagia
Correlation between VFSS evaluation and AI analysis of dysphagia
Secondary Outcome Measures
Correlation between AI analysis of dysphagia and development
Correlation between AI analysis of dysphagia and development
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05204966
Brief Title
Development of Dysphagia Evaluation Via Video Analysis Based on Deep Learning Method in Neonates and Infants and Correlation Between the Evaluation and the Development
Official Title
Development of Dysphagia Evaluation Via Video Analysis Based on Deep Learning Method in Neonates and Infants and Correlation Between the Evaluation and the Development
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to develop an evaluation of dysphagia through deep learning-based video analysis in newborns and infants, and to report the correlation with future development.
Detailed Description
Although the exact frequency of dysphagia in newborns is not known, according to a paper published by Motion et al. in 2001, the prevalence of eating problems in premature infants under 37 weeks of age was 10.5%, and in 2001, Mercado-Deane et al. reported that about 26% had dysphagia. In 1996, Reilly et al. reported that more than 90% of children with polio had oral movement disorders and 38% had dysphagia. It is known that the frequency of dysphagia in newborns and infants is not low. The risk factors that cause these dysphagia are very diverse, and dysphagia in children can be induced by causes that can affect the whole process of swallowing.
The evaluation of dysphagia can be divided into an evaluation method that does not use an instrument such as SOMA, SDS, and quality of life measurement, and an evaluation method that uses an instrument such as VFSS and FEES. However, it is difficult to conduct tests such as VFSS in newborns and infants due to poor coordination, and there is also a risk of radiation exposure. In addition, there are practical difficulties in applying the evaluation in all medical institutions because special facilities are required to implement VFSS and specialized clinical personnel are required.
The Neonatal Oral-Motor Assessment Scale (NOMAS), developed by Marjorie Meyer Palmer in 1983, is an evaluation method for dysphagia applicable to infants under 48 weeks of PMA that evaluates whether there are abnormal findings by observing sucking for 5 minutes. However, NOMAS has the disadvantage that a person has to directly observe the sucking and may show differences in results between raters.
Therefore, in this study, inspired by the evaluation method of NOMAS, investigators try to develop an evaluation method to evaluate swallowing disorders by videotaping bottle feeding in newborns and infants, then calculating and analyzing the features of the baby's face related to swallowing with artificial intelligence. investigators would like to analyze the relationship between this evaluation result and future development.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia of Newborn
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infant with suspected dysphagia
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
AI analysis
Intervention Description
Bottle feeding filming
- With a camera that can measure depth, take a video of feeding milk from a bottle for 5-10 minutes.
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.
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.
Primary Outcome Measure Information:
Title
Correlation between NOMAS evaluation and AI analysis of dysphagia
Description
Correlation between NOMAS evaluation and AI analysis of dysphagia
Time Frame
up to 2 years
Title
Correlation between VFSS evaluation and AI analysis of dysphagia
Description
Correlation between VFSS evaluation and AI analysis of dysphagia
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Correlation between AI analysis of dysphagia and development
Description
Correlation between AI analysis of dysphagia and development
Time Frame
up to 2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newborns and infants under 6 months of correctional age
Clinically suspected to have dysphagia
In case parental consent is obtained
Exclusion Criteria:
In case of cardiopulmonary instability (ECMO, Ventilator, etc. are being applied)
When it is not possible to secure sufficient fields for artificial intelligence analysis of images due to factors such as anatomical abnormalities of the head and neck
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eunjae Ko, M.D.
Phone
010-9988-6285
Ext
02-3010-3912
Email
gonjae0610@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Garam Hong, M.D.
Phone
010-9146-7738
Ext
02-3010-0769
Email
eamsmed@gmail.com
Facility Information:
Facility Name
Asan medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
1688-7575
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Development of Dysphagia Evaluation Via Video Analysis Based on Deep Learning Method in Neonates and Infants and Correlation Between the Evaluation and the Development
We'll reach out to this number within 24 hrs