Clinical trial NCT06577727: A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children
Official title: A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children (FERROUS 2)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Iron Deficiency
Keywords: Algorithm
Artificial Intelligence
Iron Deficiency
IDA
Anemia
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: KK Women's and Children's Hospital
name: Srinagarind Hospital, Khon Kaen University
First posted: 2024-08-29
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 6 to 72 months of age

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.

Eligibility criteria: 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 \&amp;amp; Innovation Center or the participating sites.

Primary outcomes:
measure: Accuracy of the Iron AI in a clinic setting
timeFrame: 1 day
Secondary outcomes:
measure: Parental acceptability of the Iron AI
timeFrame: 1 day
measure: Investigator's (or delegates) acceptability of Iron AI
timeFrame: 1 day
Other outcomes:
measure: Correlation of proposed scoring system for iron status assessment questionnaire against the gold standard blood test result
timeFrame: 1 day
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hopsital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University
Study officials:
affiliation: KK Women's and Children's Hospital
name: Poh Choo Dr Khoo
role: PRINCIPAL_INVESTIGATOR
affiliation: Srinagarind Hospital, Khon Kaen University, Khon Kaen
name: Assoc.Prof. Suchaorn Saengnipanthkul
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: WHO (2001) Iron deficiency anaemia. Assessment, prevention, and control. A guide for programme managers. Geneva: World Health Organization.
citation: 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
citation: 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.
citation: 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.
citation: Tounian P, Chouraqui JP. [Iron in nutrition]. Arch Pediatr. 2017 May;24(5S):5S23-5S31. doi: 10.1016/S0929-693X(17)24006-8. French.
citation: Vitamin and mineral requirements in human nutrition, Second edition, World Health Organization and Food and Agriculture Organization of the United Nations, 2004.
citation: Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015 May 7;372(19):1832-43. doi: 10.1056/NEJMra1401038. No abstract available.
citation: 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.