A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Risk of Iron Deficiency and Anaemia in African Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- Accuracy of the Iron digital tool in estimating hemoglobin level as compared to standard blood test.
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 African 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 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 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children over 6 months of age and under 6 years of age.
- •Written consent from the legally acceptable parent(s) or representative(s), who are themselves ≥ 18 years of age, to consent to and comply with the terms and conditions of the study.
- •The parent(s) must be able to understand the content of the study and complete the study questionnaires.
- •Parents should be comfortable with their child having blood drawn.
- •The participant must have a haemoglobin level corresponding to a haemoglobin group with open slots for participation.
排除标准
- •Children with a medical condition that, in the opinion of the investigator, would render them unsuitable for enrolment
- •Children with nail bed obstructions, nail polish, nail discoloration (e.g., leukonychia, melanonychia, bruising, etc.), or scarring of the lips, or lip pigmentation due to thyroid dysfunction (e.g., Peutz-Jeghers syndrome)
- •Children who are unable to cooperate with study procedures
- •Employees and/or children/family members or parents of employees of the Danone Global Research & Innovation Center or Danone affiliates participating sites
- •Children whose health condition requires emergency care
研究组 & 干预措施
Children aged 6-72 months of age
Approximately 120 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.
干预措施: Standard blood test (Diagnostic Test)
Children aged 6-72 months of age
Approximately 120 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.
干预措施: Imaging and videography of anatomical sites (Other)
结局指标
主要结局
Accuracy of the Iron digital tool in estimating hemoglobin level as compared to standard blood test.
时间窗: 1 day
Mean absolute error (MAE), Mean Absolute Percentage Error (MAPE) and Mean Square Error (MSE) will be calculated for accuracy
次要结局
- To evaluate Iron Questionnaire (IronQ)'s performance in estimating risk of iron intake deficiency as compared to dietary intake from 24-hour recall diary(2 days)