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

Last updated: February 2, 2025
Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Imaging and videography of anatomical sites

Gold standard blood test

Clinical Study ID

NCT06577727
EBB19GC28473 - A
  • Ages 6-72
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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), whothemselves are aged ≥ 21 years old, to consent and comply with the terms andconditions of the study

  3. Parent(s) should have access to the internet and a smartphone or tablet to completestudy questionnaires

  4. Parent(s) should be able to comprehend the content of the study and complete thestudy 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

Exclusion Criteria:

  1. Children with any medical condition that in the opinion of the investigator wouldnot 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, pigmentationson 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 GlobalResearch & Innovation Center or the participating sites.

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Imaging and videography of anatomical sites
Phase:
Study Start date:
January 15, 2025
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • KK Women's and Children's Hopsital

    Singapore,
    Singapore

    Active - Recruiting

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen,
    Thailand

    Active - Recruiting

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