Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT07186205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Risk of Iron Deficiency and Anaemia in African Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2025-09-07', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Parental acceptability of the Iron digital tool', 'timeFrame': '1 day', 'description': 'Parental acceptability of the Iron digital tool assessed via the study questionnaire \\[Accuracy, Usefulness, Frequency of usage, Data sharing\\] on a scale of 1-5 (1 being the least acceptable and 5 being the most acceptable)'}, {'measure': "Investigator's (or delegates) acceptability of Iron digital tool", 'timeFrame': '1 day', 'description': 'Investigators (or delegates) likelihood of using the Iron digital tool assessed via the study questionnaire \\[Ease of taking images/videos, accuracy, frequency of use, recommendation to parents\\] on a scale of 1- 5 (1 being the least acceptable and 5 being the most acceptable)'}], 'primaryOutcomes': [{'measure': 'Accuracy of the Iron digital tool in estimating hemoglobin level as compared to standard blood test.', 'timeFrame': '1 day', 'description': 'Mean absolute error (MAE), Mean Absolute Percentage Error (MAPE) and Mean Square Error (MSE) will be calculated for accuracy'}], 'secondaryOutcomes': [{'measure': "To evaluate Iron Questionnaire (IronQ)'s performance in estimating risk of iron intake deficiency as compared to dietary intake from 24-hour recall diary", 'timeFrame': '2 days', 'description': 'Correlation Coefficient will be calculated to measure the strength and direction of association between iron intake estimated by IronQ and the 24-hour recall.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Algorithm', 'Artificial Intelligence', 'Iron Deficiency', 'IDA', 'Anaemia'], 'conditions': ['Iron Deficiencies']}, 'referencesModule': {'references': [{'pmid': '28622779', 'type': 'BACKGROUND', '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.'}, {'pmid': '34564844', 'type': 'BACKGROUND', '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.'}, {'pmid': '26314490', 'type': 'BACKGROUND', '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.'}, {'pmid': '25946282', 'type': 'BACKGROUND', 'citation': 'Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015 May 7;372(19):1832-43. doi: 10.1056/NEJMra1401038. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in African children', 'detailedDescription': "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 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children between 6 months to years of age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children over 6 months of age and under 6 years of age.\n* Written consent from the legally acceptable parent(s) or representative(s), who are themselves ≥ 18 years of age, to consent to and comply with the terms and conditions of the study.\n* The parent(s) must be able to understand the content of the study and complete the study questionnaires.\n* Parents should be comfortable with their child having blood drawn.\n* The participant must have a haemoglobin level corresponding to a haemoglobin group with open slots for participation.\n\nExclusion Criteria:\n\n* Children with a medical condition that, in the opinion of the investigator, would render them unsuitable for enrolment\n* Children with nail bed obstructions, nail polish, nail discoloration (e.g., leukonychia, melanonychia, bruising, etc.), or scarring of the lips, or lip pigmentation due to thyroid dysfunction (e.g., Peutz-Jeghers syndrome)\n* Children who are unable to cooperate with study procedures\n* Employees and/or children/family members or parents of employees of the Danone Global Research \\& Innovation Center or Danone affiliates participating sites\n* Children whose health condition requires emergency care'}, 'identificationModule': {'nctId': 'NCT07186205', 'acronym': 'FERROUS 3', 'briefTitle': 'A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Risk of Iron Deficiency and Anaemia in African Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Asia Pacific Holdings Pte, Ltd.'}, 'officialTitle': 'A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Risk of Iron Deficiency and Anaemia in African Children', 'orgStudyIdInfo': {'id': '24REX0083183'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children aged 6-72 months of age', 'description': 'Approximately 120 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.', 'interventionNames': ['Diagnostic Test: Standard blood test', 'Other: Imaging and videography of anatomical sites']}], 'interventions': [{'name': 'Standard blood test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood test will measure haemoglobin and other parameters', 'armGroupLabels': ['Children aged 6-72 months of age']}, {'name': 'Imaging and videography of anatomical sites', 'type': 'OTHER', 'description': 'Images and videos of anatomical sites will be collected to develop algorithms to estimate iron status', 'armGroupLabels': ['Children aged 6-72 months of age']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'contacts': [{'name': 'Francis Béranger Angelo Dr. AKA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hospital Center Régional D'abobo Félix Houphouët Boigny", 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'contacts': [{'name': 'Kaudjhis Regine Hermione Dr. ASSI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut National de Sante Publique', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Bingerville', 'country': 'Côte d’Ivoire', 'contacts': [{'name': 'Yolande Kiele Dr. KESSIA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Mère Enfant Bingerville', 'geoPoint': {'lat': 5.35581, 'lon': -3.88537}}], 'centralContacts': [{'name': 'Muhammad Nabeel Digital Health Study Manager, BSc', 'role': 'CONTACT', 'email': 'muhammad-nabeel.eusoff@danone.com', 'phone': '+6591293006'}], 'overallOfficials': [{'name': 'Amed Coulibaly, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut National de Santé Publique (INSP)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Asia Pacific Holdings Pte, Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Institut National de Sante Publique', 'class': 'OTHER'}, {'name': "Hospital Center Régional D'abobo Félix Houphouët Boigny", 'class': 'UNKNOWN'}, {'name': 'Hôpital Mère Enfant Bingerville', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}