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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06577727
Acronym
FERROUS 2
Enrollment
250
Registered
2024-08-29
Start date
2025-01-15
Completion date
2025-09-30
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency

Keywords

Algorithm, Artificial Intelligence, Iron Deficiency, IDA, Anemia

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.

Interventions

OTHERGold standard blood test

Blood test will measure haemoglobin and other parameters

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

Sponsors

Danone Asia Pacific Holdings Pte, Ltd.
Lead SponsorINDUSTRY
KK Women's and Children's Hospital
CollaboratorOTHER_GOV
Srinagarind Hospital, Khon Kaen University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 72 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the Iron AI in a clinic setting1 dayAccuracy 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

MeasureTime frameDescription
Parental acceptability of the Iron AI1 dayParental acceptability of the Iron AI assessed via the study questionnaire \[Accuracy, Usefulness, Frequency of usage, Data sharing\]
Investigator's (or delegates) acceptability of Iron AI1 dayInvestigators (or delegates) likelihood of using the Iron AI assessed via the study questionnaire \[Ease of taking images/videos, accuracy, frequency of use, recommendation to parents\]

Countries

Singapore, Thailand

Contacts

PRINCIPAL_INVESTIGATORPoh Choo Dr Khoo

KK Women's and Children's Hospital

PRINCIPAL_INVESTIGATORAssoc.Prof. Suchaorn Saengnipanthkul

Srinagarind Hospital, Khon Kaen University, Khon Kaen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026