Status:
RECRUITING
A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children
Lead Sponsor:
Danone Asia Pacific Holdings Pte, Ltd.
Collaborating Sponsors:
KK Women's and Children's Hospital
Srinagarind Hospital, Khon Kaen University
Conditions:
Iron Deficiency
Eligibility:
All Genders
6-72 years
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 ve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06577727
Start Date
January 15 2025
End Date
October 31 2025
Last Update
August 20 2025
Active Locations (2)
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1
KK Women's and Children's Hopsital
Singapore, Singapore
2
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Thailand