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

Recruiting

• Conditions: Iron Deficiency
• Interventions: Other: Gold standard blood test; Other: Imaging and videography of anatomical sites

• Registration Number: NCT06577727
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

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 Timeline

• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-29
• Study Start: 2025-01-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children aged 6-72 months of age	Gold standard blood test	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.
Children aged 6-72 months of age	Imaging and videography of anatomical sites	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of the Iron AI in a clinic setting	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 Outcome Measures

Name	Time	Method
Parental acceptability of the Iron AI	1 day	Parental acceptability of the Iron AI assessed via the study questionnaire \[Accuracy, Usefulness, Frequency of usage, Data sharing\]
Investigator's (or delegates) acceptability of Iron AI	1 day	Investigators (or delegates) likelihood of using the Iron AI assessed via the study questionnaire \[Ease of taking images/videos, accuracy, frequency of use, recommendation to parents\]

Trial Locations

Locations (2)

KK Women's and Children's Hopsital; 🇸🇬 Singapore, Singapore

Srinagarind Hospital, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand