Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-28 @ 2:46 AM
Study NCT ID:
NCT05707858
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2023-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Naples Pediatric Food Allergy (NAPFA) Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-10', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of a new clinical score for the identification of pediatric FA in primary care setting', 'timeFrame': 'at the enrollment', 'description': 'The score will include the main anamnestic and clinical features'}], 'secondaryOutcomes': [{'measure': 'Development of a new clinical score for the identification of pediatric FA in secondary and tertiary care setting', 'timeFrame': 'at the enrollment', 'description': 'The score will include the main anamnestic and clinical features'}, {'measure': 'Validation of the new clinical NAPFA score for the identification of pediatric FA', 'timeFrame': 'at the enrollment', 'description': 'Validation of the score on pediatric subject with suspected FA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food allergy'], 'conditions': ['Food Allergy in Children']}, 'descriptionModule': {'briefSummary': 'Food Allergy (FA) is one of the most expensive allergic disorders in the pediatric age, and affecting up to 10% of children worldwide, it is recognized as a global health problem. The Oral Food Challenge (OFC) is the gold standard for FA diagnosis, but it is time-consuming, expensive, and potentially dangerous, as it can determine severe anaphylaxis. In addition, causing long-lasting impact on patient anxiety and mental health due to the physical duress and health risks involved with its application, OFC strategy is little applied in clinical practice with consequent diagnostic errors and delays. The goal of the Naples Pediatric Food Allergy (NAPFA) score is to develop a new clinical score including the main anamnestic, and clinical features for the easy identification of pediatric FA in primary care setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Week', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects consecutively observed at the Pediatric Allergy Program, at the Department of Translational Medical Science of the University of Naples Federico II, both sex, aged 0-14 years with suggestive history of food allergy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects aged between 0-14 years with suggestive history of food allergy\n\nExclusion Criteria:\n\n* Exclusion criteria: age \\>14 years\n* chronic systemic diseases,\n* malignancy,\n* immunodeficiency,\n* infectious diseases,\n* autoimmune diseases,\n* inflammatory bowel diseases,\n* celiac disease,\n* metabolic and genetic diseases,\n* cystic fibrosis,\n* chronic pulmonary diseases,\n* gastrointestinal, respiratory, urinary tract and/or cardiovascular malformations,\n* neurologic and/or neuropsychiatric disorders,\n* gastrointestinal tract eosinophilic disorders,\n* use of immunomodulating drugs in the previous 4 months\n* use of steroids and antihistamines in the previous 2 weeks'}, 'identificationModule': {'nctId': 'NCT05707858', 'acronym': 'NAPFA', 'briefTitle': 'The Naples Pediatric Food Allergy (NAPFA) Score', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'The Naples Pediatric Food Allergy (NAPFA) Score', 'orgStudyIdInfo': {'id': '284/21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subject with suspected food allergy', 'interventionNames': ['Other: Development of the NAPFA score']}], 'interventions': [{'name': 'Development of the NAPFA score', 'type': 'OTHER', 'description': 'In subjects with suspected food allergy we will evaluate main anamnestic, and clinical features to develop the NAPFA score', 'armGroupLabels': ['Subject with suspected food allergy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Department of Traslational Medical Science - University of Naples Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Roberto Berni Canani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Translational Medical Science, University of Naples Federico II'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Roberto Berni Canani, MD, PhD', 'investigatorAffiliation': 'Federico II University'}}}}