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

NCT06577727 | Completed

• 1 other identifier: EBB19GC28473 - A
• Study Type: observational
• Target: 250
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Iron Deficiency

Keywords

Algorithm; Artificial Intelligence; Iron Deficiency; IDA; Anemia

Outcome Measures

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

  1 day

Secondary Outcomes (2)

• Parental acceptability of the Iron AI

  1 day

• Investigator's (or delegates) acceptability of Iron AI

  1 day

Other Outcomes (1)

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

  1 day

Study Arms (1)

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

Gold standard blood test OTHER

Blood test will measure haemoglobin and other parameters

Children aged 6-72 months of age

Imaging and videography of anatomical sites OTHER

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

Children aged 6-72 months of age

Eligibility Criteria

• Age: 6 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between 6 to 72 months of age

You may qualify if:

• 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

You may not qualify if:

• 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 \&amp;amp; Innovation Center or the participating sites.

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead
• KK Women's and Children's Hospital: collaborator
• Srinagarind Hospital, Khon Kaen University: collaborator

Study Sites (2)

KK Women's and Children's Hopsital

Singapore, Singapore

Location

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Thailand

Location

Related Publications (12)

• 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.

  PMID: 20923825 BACKGROUND

• 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.

  PMID: 26314490 BACKGROUND

• 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.

  PMID: 18574611 BACKGROUND

• 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.

  BACKGROUND

• WHO (2001) Iron deficiency anaemia. Assessment, prevention, and control. A guide for programme managers. Geneva: World Health Organization.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 577504 BACKGROUND

• 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.

  PMID: 34564844 BACKGROUND

• Tounian P, Chouraqui JP. [Iron in nutrition]. Arch Pediatr. 2017 May;24(5S):5S23-5S31. doi: 10.1016/S0929-693X(17)24006-8. French.

  PMID: 28622779 BACKGROUND

• Vitamin and mineral requirements in human nutrition, Second edition, World Health Organization and Food and Agriculture Organization of the United Nations, 2004.

  BACKGROUND

• Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015 May 7;372(19):1832-43. doi: 10.1056/NEJMra1401038. No abstract available.

  PMID: 25946282 BACKGROUND

• 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.

  PMID: 11533374 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Anemia

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Poh Choo Dr Khoo

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

• Assoc.Prof. Suchaorn Saengnipanthkul

  Srinagarind Hospital, Khon Kaen University, Khon Kaen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: January 15, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1); SG (1)