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

Danone

Status: Completed

Conditions: Iron Deficiency

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06577727

EBB19GC28473 - A

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 6 to 72 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

250 participants in 1 patient group

Children aged 6-72 months of age

Description:

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.

Treatment:

Other: Gold standard blood test

Other: Imaging and videography of anatomical sites