A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children (FERROUS 2)
February 2, 2026 updated by: Danone Asia Pacific Holdings Pte, Ltd.
A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children (FERROUS 2)
An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in children
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Children between 6 to 72 months of age
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children aged 6-72 months of age
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. |
Blood test will measure haemoglobin and other parameters
Images and videos of anatomical sites will be collected for AI to estimate iron status
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of the Iron AI in a clinic setting
Time Frame: 1 day
|
Accuracy of the Iron Ai in a clinic setting, derived from:
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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]
|
1 day
|
|
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]
|
1 day
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation of proposed scoring system for iron status assessment questionnaire against the gold standard blood test result
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Poh Choo Dr Khoo, KK Women's and Children's Hospital
- Principal Investigator: Assoc.Prof. Suchaorn Saengnipanthkul, Srinagarind Hospital, Khon Kaen University, Khon Kaen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015 May 7;372(19):1832-43. doi: 10.1056/NEJMra1401038. No abstract available.
- Lopez A, Cacoub P, Macdougall IC, Peyrin-Biroulet L. Iron deficiency anaemia. Lancet. 2016 Feb 27;387(10021):907-16. doi: 10.1016/S0140-6736(15)60865-0. Epub 2015 Aug 24.
- Baker RD, Greer FR; Committee on Nutrition American Academy of Pediatrics. Diagnosis and prevention of iron deficiency and iron-deficiency anemia in infants and young children (0-3 years of age). Pediatrics. 2010 Nov;126(5):1040-50. doi: 10.1542/peds.2010-2576. Epub 2010 Oct 5.
- Khedr E, Hamed SA, Elbeih E, El-Shereef H, Ahmad Y, Ahmed S. Iron states and cognitive abilities in young adults: neuropsychological and neurophysiological assessment. Eur Arch Psychiatry Clin Neurosci. 2008 Dec;258(8):489-96. doi: 10.1007/s00406-008-0822-y. Epub 2008 Jun 20.
- WHO (2008) Worldwide prevalence of anaemia 1993-2005. In: de Benoist B, McLean E, Egli I, Cogswell M, editors. WHO global database on anaemia. Geneva: World Health Organization.
- WHO (2001) Iron deficiency anaemia. Assessment, prevention, and control. A guide for programme managers. Geneva: World Health Organization.
- Anaemia in women and children (2021). World Health Organization. https://www.who.int/data/gho/data/themes/topics/anaemia_in_women_and_children?utm_content=buffer85683&utm
- Saarinen UM, Siimes MA, Dallman PR. Iron absorption in infants: high bioavailability of breast milk iron as indicated by the extrinsic tag method of iron absorption and by the concentration of serum ferritin. J Pediatr. 1977 Jul;91(1):36-9. doi: 10.1016/s0022-3476(77)80439-3.
- da Silva Lopes K, Yamaji N, Rahman MO, Suto M, Takemoto Y, Garcia-Casal MN, Ota E. Nutrition-specific interventions for preventing and controlling anaemia throughout the life cycle: an overview of systematic reviews. Cochrane Database Syst Rev. 2021 Sep 26;9(9):CD013092. doi: 10.1002/14651858.CD013092.pub2.
- Tounian P, Chouraqui JP. [Iron in nutrition]. Arch Pediatr. 2017 May;24(5S):5S23-5S31. doi: 10.1016/S0929-693X(17)24006-8. French.
- Vitamin and mineral requirements in human nutrition, Second edition, World Health Organization and Food and Agriculture Organization of the United Nations, 2004.
- Kohli-Kumar M. Screening for anemia in children: AAP recommendations--a critique. Pediatrics. 2001 Sep;108(3):E56. doi: 10.1542/peds.108.3.e56.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2025
Primary Completion (Actual)
September 30, 2025
Study Completion (Actual)
September 30, 2025
Study Registration Dates
First Submitted
August 27, 2024
First Submitted That Met QC Criteria
August 27, 2024
First Posted (Actual)
August 29, 2024
Study Record Updates
Last Update Posted (Actual)
February 4, 2026
Last Update Submitted That Met QC Criteria
February 2, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBB19GC28473 - A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.