CompletedNot Applicable

A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children

Singapore, Thailand250 participantsStarted 2025-01-15

Plain-language summary

An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in children

Age range6 Months – 72 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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 \&amp; Innovation Center or the participating sites.

Accuracy of the Iron AI in a clinic setting

Timeframe: 1 day

NCT IDNCT06577727

SponsorDanone Asia Pacific Holdings Pte, Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-30

Who can participate

Age range6 Months – 72 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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 \&amp; Innovation Center or the participating sites.