A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children (FERROUS 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Accuracy of the Iron AI in a clinic setting
研究概览
简要总结
An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in children
详细描述
This is an exploratory, observational, pilot study that aims to build and measure the accuracy of an algorithm that estimates a child's iron status using images and/or videos, against gold standard venous blood sampling. Images and/or videos will be collected by healthcare professionals, together with blood test results. This data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. Data on the acceptance and experience of the using the algorithm will be collected for improvements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children above 6 months of age and below 6 years of age
- •Written consent from parent(s) or legally acceptable representative(s), who themselves are aged ≥ 21 years old, to consent and comply with the terms and conditions of the study
- •Parent(s) should have access to the internet and a smartphone or tablet to complete study questionnaires
- •Parent(s) should be able to comprehend the content of the study and complete the study questionnaires
- •Parents(s) must be comfortable with their child having blood draws
- •Subject has a Hb level corresponding to a Hb group with open slots for participation
排除标准
- •Children with any medical condition that in the opinion of the investigator would not be suitable for enrolment.
- •Children with nail bed obstructions, nail polish, nails discolouration (e.g., leukonychia, melanonychia, bruising, etc.), or scarring of the lips, pigmentations on lips for thyroid dysfunction (e.g., Puettz-jeghers syndrome).
- •Children who are unable to cooperate with study procedures.
- •Employees and/or children/family members or relatives of employees of Danone Global Research & Innovation Center or the participating sites.
研究组 & 干预措施
Children aged 6-72 months of age
Approximately 250 children aged above 6 months old and below 6 years of age across potential study sites.
Subjects will be grouped by haemoglobin (Hb) level ranging from <6 g/dL to ≥ 14.0 g/dL. There will be a minimum of 10 subjects and a maximum of 25 subjects for each group.
干预措施: Gold standard blood test (Other)
Children aged 6-72 months of age
Approximately 250 children aged above 6 months old and below 6 years of age across potential study sites.
Subjects will be grouped by haemoglobin (Hb) level ranging from <6 g/dL to ≥ 14.0 g/dL. There will be a minimum of 10 subjects and a maximum of 25 subjects for each group.
干预措施: Imaging and videography of anatomical sites (Other)
结局指标
主要结局
Accuracy of the Iron AI in a clinic setting
时间窗: 1 day
Accuracy of the Iron Ai in a clinic setting, derived from: 1. The Iron AI prediction from images/videos collected 2. The gold standard blood test results
次要结局
- Parental acceptability of the Iron AI(1 day)
- Investigator's (or delegates) acceptability of Iron AI(1 day)