Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-05 @ 11:18 PM
Study NCT ID:
NCT02640560
Status:
COMPLETED
Last Update Posted:
2015-12-29
First Post:
2015-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-23', 'studyFirstSubmitDate': '2015-12-09', 'studyFirstSubmitQcDate': '2015-12-23', 'lastUpdatePostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Anaphylaxis in 1 year', 'timeFrame': '1 year', 'description': 'To determine the frequency of anaphylaxis in allergic outpatient children'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Children', 'Allergy', 'Peanuts', 'Hazelnuts', 'Walnuts', 'Mollusks', 'Shellfish', 'Food'], 'conditions': ['Food Allergy']}, 'descriptionModule': {'briefSummary': 'In Italy, few data about anaphylaxis due to peanuts in pediatric age are available, conversely data about walnuts/hazelnuts, shellfish/mollusks anaphylaxis have not yet been collected.\n\nChildren with physician-confirmed food allergy to peanuts, walnuts/hazelnuts and shellfish/mollusks will be recruited from 9 allergy clinics located in the Italian Territory (Bologna, Lecce, Napoli, Palermo, Parma, Pavia, Roma, Torino, Trento).\n\nParent of food allergic children will compile a food allergy questionnaire (questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources).\n\nParent of healthy children will compile a control questionnaire (questions about general information on the family, on life and food habits and on indoor environment) The 1-year survey will determine the frequency of anaphylaxis in allergic outpatient children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '200 Italian children with or without food allergy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Cases: 0-14 years old patients with food allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.\n* Controls: 0-14 years old subjects without allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.\n\nExclusion criteria\n\n* Patients/subjects in acute phase of disease or with not controlled chronic pathologies;\n* missing written informed consent by parents'}, 'identificationModule': {'nctId': 'NCT02640560', 'briefTitle': 'One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish', 'organization': {'class': 'OTHER', 'fullName': "Istituto per la Ricerca e l'Innovazione Biomedica"}, 'officialTitle': 'One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish', 'orgStudyIdInfo': {'id': '10/2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with food allergy', 'description': 'Children with food allergy to nuts, hazelnuts, walnuts, shellfish and mollusks (1-14 years old).\n\nThe Parents of the cases children will compile a Food allergy questionnaire', 'interventionNames': ['Other: Food allergy questionnaire']}, {'label': 'Healthy Children', 'description': 'Healthy Children (1-14 years old) The Parents of the control children will compile a Control questionnaire', 'interventionNames': ['Other: Control Questionnaire']}], 'interventions': [{'name': 'Food allergy questionnaire', 'type': 'OTHER', 'description': 'The Parents of the cases children will compile a questionnaire including questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources', 'armGroupLabels': ['Children with food allergy']}, {'name': 'Control Questionnaire', 'type': 'OTHER', 'description': 'The Parents of the control children will compile a questionnaire including questions about general information on the family, on life and food habits and on indoor environment.', 'armGroupLabels': ['Healthy Children']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stefania La Grutta, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.', 'investigatorFullName': 'Stefania La Grutta, MD', 'investigatorAffiliation': "Istituto per la Ricerca e l'Innovazione Biomedica"}}}}