Dysphagia of NewbornNCT05204966
Development of Dysphagia Evaluation Via Video Analysis Based on Deep Learning Method in Neonates and Infants and Correlation Between the Evaluation and the Development
A study testing AI analysis in people with Dysphagia of Newborn, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Dysphagia of Newborn
- What is being tested?
- AI analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Aug 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns and infants under 6 months of correctional age
- Clinically suspected to have dysphagia
- In case parental consent is obtained
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan medical Center
Seoul, 05505
1688-7575
About this study
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.
Read the 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.
- Conditions
- Dysphagia of Newborn
- Being tested
- AI analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI analysisDiagnostic test
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: AI analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between NOMAS evaluation and AI analysis of dysphagia
Correlation between NOMAS evaluation and AI analysis of dysphagia
Measured: up to 2 years
Correlation between VFSS evaluation and AI analysis of dysphagia
Correlation between VFSS evaluation and AI analysis of dysphagia
Measured: up to 2 years
Secondary outcomes (1)
Correlation between AI analysis of dysphagia and development
Correlation between AI analysis of dysphagia and development
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start2 Aug 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Garam, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204966
- Sponsor's protocol ID
- S2021-1661-0001
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05204966
- Acronym / sponsor ID
- S2021-1661-0001
- Conditions
- Dysphagia of Newborn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant with suspected dysphagia | Other | Diagnostic Test: AI analysisFor 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. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns and infants under 6 months of correctional age
- Clinically suspected to have dysphagia
- In case parental consent is obtained
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI analysis1. 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. | Diagnostic test | Infant with suspected dysphagia |
Primary outcome
Correlation between NOMAS evaluation and AI analysis of dysphagia
Time frame: up to 2 years
Correlation between NOMAS evaluation and AI analysis of dysphagia
Correlation between VFSS evaluation and AI analysis of dysphagia
Time frame: up to 2 years
Correlation between VFSS evaluation and AI analysis of dysphagia
1 secondary outcome
Correlation between AI analysis of dysphagia and development
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI analysis in people with Dysphagia of Newborn, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eunjae Ko, M.D. (010-9988-6285 ext. 02-3010-3912, gonjae0610@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between NOMAS evaluation and AI analysis of dysphagia (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.