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临床试验/NCT06920550
NCT06920550进行中(未招募)不适用

A Growth Artificial Intelligence Algorithm for leNgth and Weight Study

Nutricia Research4 个研究点 分布在 3 个国家目标入组 250 人开始时间: 2024年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
250
试验地点
4
主要终点
Accuracy length AI

研究概览

简要总结

This is a data collection and machine learning accuracy testing project that aims to a) collect training data to enhance, by machine learning, an artificial intelligence (AI) algorithm for measuring length in infants and young children and b) test the accuracy of the AI algorithm by comparing the AI predicted length with the gold standard measured length. Images and videos will be collected by care givers and healthcare professionals, together with physical length measurements. These data will be used to train the AI algorithm and to explore potential improvements. Other data to be collected is user experience feedback.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
0 Months 至 24 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Infants/young children aged 0 to 24 months old at enrolment;
  • •Caregiver(s) have access to the internet and a smartphone or tablet to complete questionnaires, take images and videos, and upload these;
  • •Written informed consent from one or both caregivers (according to local laws) or legally acceptable representative(s) aged ≥ 18 years at enrolment.

排除标准

  • •Children unable to undergo length or weight measurements when applying standardized techniques recommended by the WHO (e.g. infants/children with structural abnormalities of the lower limbs or orthopaedic conditions (e.g. club foot, hip dysplasia)).
  • •Research staff's uncertainty about the caregiver's ability or willingness to complete the study according to the instructions

研究组 & 干预措施

Children 0-24 months

Children aged 0-24 months of age with no structural abnormalities of the lower limbs or orthopedic conditions

结局指标

主要结局

Accuracy length AI

时间窗: Date of enrolment, at baseline

Accuracy of the Length AI vs length gold standard (WHO methodology with length board in cm) assessed using several different parameters: the bias (cm), agreement and reliability measures, mean absolute error (cm), mean absolute percentage error (%), percentiles of the absolute error (cm), and root mean square error (cm).

Accuracy caregiver length

时间窗: Date of enrolment, at baseline

Accuracy of the caregiver measured length (own preferred methodology in cm) vs gold standard measured length (WHO methodology with length board in cm), assessed by same parameters as mentioned in the first primary outcome measure.

Accuracy caregiver vs AI length

时间窗: Date of enrolment, at baseline

Accuracy of the caregiver measurements (self preferred methodology in cm) vs Length AI by same parameters as mentioned in the first primary outcome measure.

次要结局

  • Accuracy weight AI(Date of enrolment, at baseline)
  • Ease of use tool(Date of enrolment, at baseline)
  • Accuracy caregiver weight(Date of enrolment, at baseline)
  • Acceptability tool(Date of enrolment, at baseline)

研究者

发起方
Nutricia Research
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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