Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
Study NCT ID:
NCT03942692
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2019-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000707', 'term': 'Anaphylaxis'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2019-05-07', 'lastUpdatePostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Allergy follow-up', 'timeFrame': 'About 15 minutes', 'description': 'Allergy follow-up evaluation with :\n\n* the frequency of consultations with an allergist\n* the information of the general practitioner or pediatrician\n* the prescription of epinephrin auto-injector\n* the frequency of renewal of epinephrin auto-injector\n* the specialty of doctor who prescribed the renewal\n* the implementation of specific measures in schools\n* the frequency of renewal of specific measures in schools\n* the number of recurrence of anaphylactic reaction\n* the use of medical advice in case of recurrence of anaphylactic reaction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anaphylaxis', 'Allergic Reaction']}, 'descriptionModule': {'briefSummary': 'Anaphylaxis is an allergic reaction potentially fatal. The treatment is based on injection of epinephrin as soon as possible. Guidelines by the World Allergic Organisation highlight the importance of medical follow-up. This follow-up consists of an allergy consultation, the prescription and demonstration of epinephrin auto-injector and the implementation of specific measures in schools. There is no study about the recurrence of anaphylactic reaction outside the hospital.\n\nThe purpose of this study is to evaluate the allergy follow-up of children after anaphylactic reaction. The secondary objective is to evaluate the use of medical advice in case of recurrence of anaphylactic reaction.\n\nInvestigators will use a phone call questionnaire for parents of children who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in the Paediatric Emergency Department in Femme-Mère-Enfant Hospital in Lyon in France. 179 children could be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children from 0 to 18 year old who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 0 to 17\n* Anaphylactic reaction meeting the criteria of Sampson et al. treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France\n* Anaphylactic reaction treated between the 1st July 2014 and the 31st June 2016\n\nExclusion Criteria:\n\n\\- No agreement from patient or parents to participate in the study'}, 'identificationModule': {'nctId': 'NCT03942692', 'acronym': 'SAPRA', 'briefTitle': 'What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction', 'orgStudyIdInfo': {'id': '69HCL18_0493'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with anaphylactic reaction', 'description': 'Children who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France.', 'interventionNames': ['Other: Phone call questionnaire']}], 'interventions': [{'name': 'Phone call questionnaire', 'type': 'OTHER', 'description': 'Questionnaire for parents of subject about :\n\n* the frequency of consultations with an allergist\n* the information of the general practitioner or pediatrician\n* the prescription of epinephrin auto-injector\n* the frequency of renewal of epinephrin auto-injector\n* the specialty of doctor who prescribed the renewal\n* the implementation of specific measures in schools\n* the frequency of renewal of specific measures in schools\n* the number of recurrence of anaphylactic reaction\n* the use of medical advice in case of recurrence of anaphylactic reaction', 'armGroupLabels': ['Children with anaphylactic reaction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Paediatric Emergency Department in Femme-Mère-Enfant Hospital', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}