A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children (FERROUS 2)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Accuracy of the Iron AI in a clinic setting
Study Overview
Brief Summary
An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in children
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Months to 72 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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.
Intervention: Imaging and videography of anatomical sites (Other)
Outcomes
Primary Outcomes
Accuracy of the Iron AI in a clinic setting
Time Frame: 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
Secondary Outcomes
- Parental acceptability of the Iron AI(1 day)
- Investigator's (or delegates) acceptability of Iron AI(1 day)