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临床试验/NCT05204966
NCT05204966Unknown不适用

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

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年8月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Correlation between NOMAS evaluation and AI analysis of dysphagia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Newborns and infants under 6 months of correctional age
  • •Clinically suspected to have dysphagia
  • •In case parental consent is obtained

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: AI analysis (Diagnostic Test)

结局指标

主要结局

Correlation between NOMAS evaluation and AI analysis of dysphagia

时间窗: up to 2 years

Correlation between NOMAS evaluation and AI analysis of dysphagia

Correlation between VFSS evaluation and AI analysis of dysphagia

时间窗: up to 2 years

Correlation between VFSS evaluation and AI analysis of dysphagia

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Garam

Director, Principal investigator, Resident of Physical Medicine and Rehabilitation

Asan Medical Center

研究点 (1)

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