Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-25 @ 11:42 PM
Study NCT ID:
NCT05652166
Status:
UNKNOWN
Last Update Posted:
2022-12-15
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify the instructions memorized by the parents after a visit to the hospital for a foreign body ingestion by their child.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Information Remembered by Parents Following the Ingestion of Foreign Body by Their Child']}, 'descriptionModule': {'briefSummary': "Foreign body (FB) ingestion is a very common domestic accident in children. The prevention of the recurrence by securing child's environment is mandatory. The study will study whether the advices of follow-up at home and recurrence prophylaxis were given to parents after a foreign ingestion by their child.", 'detailedDescription': 'Foreign body ingestion (FB) is a very common domestic accident in children. When the FB is not dangerous or it is inaccessible after crossing the pylorus, the child should be monitored. In all cases, recurrence should be prevented by securing the environment of the swallowing child. The information on monitoring and securing the environment should be communicated during hospital care. This prospective study will analyze whether advices were correctly given to the families concerning the follow-up at home and the prophylaxis of FB ingestion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children consulting at Robert Debre Hospital following the ingestion of foreign body', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children under 18 years\n* Foreign body ingestion\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Non-French speaking parents'}, 'identificationModule': {'nctId': 'NCT05652166', 'acronym': 'MICE', 'briefTitle': 'What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?', 'orgStudyIdInfo': {'id': 'APHP-MICE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'telephone interview', 'type': 'OTHER', 'description': 'telephone call to parents to know the information given following the ingestion of foreign body by their child'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme VIALA, MD, PhD', 'role': 'CONTACT', 'email': 'jerome.viala@aphp.fr', 'phone': '+3340030000'}, {'name': 'Naim DRID, MD', 'role': 'CONTACT', 'email': 'naim.drid@aphp.fr', 'phone': '+3340030000'}], 'facility': 'Robert Debre Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Jérôme VIALA, MD, PhD', 'role': 'CONTACT', 'email': 'jerome.viala@aphp.fr', 'phone': '+33140030000'}, {'name': 'Naim DRID, MD', 'role': 'CONTACT', 'email': 'naim.drid@aphp.fr', 'phone': '+33140030000'}], 'overallOfficials': [{'name': 'Jérôme VIALA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}