Collecting data to create AI algorithms for assessing iron status in children
A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children (FERROUS 2)
This study is testing if using pictures and videos can help doctors check iron levels in children as accurately as blood tests do.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 6 Months to 72 Months |
| Sex | All |
| Sponsor | Danone Asia Pacific Holdings Pte, Ltd. Industry-sponsored |
| Locations | 2 sites (Singapore and 1 other locations) |
| Trial ID | NCT06577727 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to develop and evaluate the accuracy of artificial intelligence algorithms that estimate iron status in children using images and videos, compared to traditional blood sampling methods. Healthcare professionals will collect these images and videos alongside blood test results to assess the algorithm's performance. The study also seeks to gather data on the user experience and acceptance of the algorithm to identify areas for improvement.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 months to 6 years who require assessment for iron deficiency.
Not a fit: Patients with medical conditions that may interfere with participation or those with specific nail or lip conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive and efficient method for assessing iron deficiency in children.
How similar studies have performed: While the use of AI in medical diagnostics is growing, this specific approach to estimating iron status in children is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children above 6 months of age and below 6 years of age 2. 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 3. Parent(s) should have access to the internet and a smartphone or tablet to complete study questionnaires 4. Parent(s) should be able to comprehend the content of the study and complete the study questionnaires 5. Parents(s) must be comfortable with their child having blood draws 6. Subject has a Hb level corresponding to a Hb group with open slots for participation Exclusion Criteria: 1. Children with any medical condition that in the opinion of the investigator would not be suitable for enrolment. 2. 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). 3. Children who are unable to cooperate with study procedures. 4. Employees and/or children/family members or relatives of employees of Danone Global Research \& Innovation Center or the participating sites.
Where this trial is running
Singapore and 1 other locations
- KK Women's and Children's Hopsital — Singapore, Singapore (Recruiting)
- Srinagarind Hospital, Khon Kaen University — Khon Kaen, Thailand (Recruiting)
Study contacts
- Principal investigator: Poh Choo Dr Khoo — KK Women's and Children's Hospital
- Study coordinator: Muhammad Nabeel Eusoff, BSc
- Email: muhammad-nabeel.eusoff@danone.com
- Phone: 6591293006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.