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Completed

NCT Number: NCT06577727

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

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

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Key information

Age range

6 month–72 month

Sex eligibility

All sexes

Study type

Observational

Primary location

KK Women's and Children's Hopsital, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Gold standard blood test

Other

Blood test will measure haemoglobin and other parameters

Imaging and videography of anatomical sites

Other

Images and videos of anatomical sites will be collected for AI to estimate iron status

Primary outcomes

  1. Accuracy of the Iron AI in a clinic setting

    Time frame: 1 day

    Accuracy of the Iron Ai in a clinic setting, derived from:

    • The Iron AI prediction from images/videos collected
    • The gold standard blood test results

Secondary outcomes

  1. Parental acceptability of the Iron AI

    Time frame: 1 day

    Parental acceptability of the Iron AI assessed via the study questionnaire [Accuracy, Usefulness, Frequency of usage, Data sharing]

  2. Investigator's (or delegates) acceptability of Iron AI

    Time frame: 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]

Other outcomes

  1. Correlation of proposed scoring system for iron status assessment questionnaire against the gold standard blood test result

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Industry

Collaborators

  • KK Women's and Children's Hospital
  • Srinagarind Hospital, Khon Kaen University

Registry information

Official study title

A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children (FERROUS 2)

Acronym: FERROUS 2

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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