ClinicalTrials.gg
CompletedNCT06577727FERROUS 2Updated Feb 4, 2026

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

An observational study in Iron Deficiency, sponsored by Danone Asia Pacific Holdings Pte, Ltd.. Completed at 2 sites in 2 countries. Open to participants aged 6 Months to 72 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Danone Asia Pacific Holdings Pte, Ltd. (part of Danone) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
6 Months to 72 Months
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Iron Deficiency

Keywords

  • Algorithm
  • Artificial Intelligence
  • Iron Deficiency
  • IDA
  • Anemia
03

In context

Iron Deficiencies

386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.

This study's enrollment of 250 is above the median of 200 across 77 observational studies indexed under Iron Deficiencies.

Browse Iron Deficiencies studies →

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 72 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children between 6 to 72 months of age

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 level corresponding to a Hb group with open slots for participation

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Gold standard blood test · Other: Imaging and videography of anatomical sites

Interventions

  • OtherGold standard blood test

    Blood test will measure haemoglobin and other parameters

  • OtherImaging and videography of anatomical sites

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

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What researchers measure

Primary outcomes

  1. Accuracy of the Iron AI in a clinic setting

    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

    Time frame: 1 day

Secondary outcomes

  1. Parental acceptability of the Iron AI

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

    Time frame: 1 day

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

    Investigators (or delegates) likelihood of using the Iron AI assessed via the study questionnaire \[Ease of taking images/videos, accuracy, frequency of use, recommendation to parents\]

    Time frame: 1 day

Other outcomes

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

    Time frame: 1 day

07

Study locations

2 sites
  • KK Women's and Children's Hopsital
    Singapore, Singapore
  • Srinagarind Hospital, Khon Kaen University
    Khon Kaen, Thailand
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References and documents

Publications

  • 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. PubMed 20923825 ↗
  • 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. PubMed 26314490 ↗
  • 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. PubMed 18574611 ↗
  • 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. PubMed 577504 ↗
  • 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. PubMed 34564844 ↗
  • Tounian P, Chouraqui JP. [Iron in nutrition]. Arch Pediatr. 2017 May;24(5S):5S23-5S31. doi: 10.1016/S0929-693X(17)24006-8. French. PubMed 28622779 ↗
  • Vitamin and mineral requirements in human nutrition, Second edition, World Health Organization and Food and Agriculture Organization of the United Nations, 2004.
  • Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015 May 7;372(19):1832-43. doi: 10.1056/NEJMra1401038. No abstract available. PubMed 25946282 ↗
  • 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. PubMed 11533374 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06577727
Collaborators
KK Women's and Children's Hospital, Srinagarind Hospital, Khon Kaen University
Responsible party
Sponsor
First posted
Aug 29, 2024
Start date
Jan 15, 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025
Last update
Feb 4, 2026

Study contacts

Poh Choo Dr Khoo
principal investigator · KK Women's and Children's Hospital
Assoc.Prof. Suchaorn Saengnipanthkul
principal investigator · Srinagarind Hospital, Khon Kaen University, Khon Kaen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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