Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT04648605
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2020-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-traumatic Stress Disorder After Pediatric Intensive Care Unit Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of post-traumatic stress disorder among parents of newborns, infants and children who have been hospitalized in a paediatric resuscitation unit.', 'timeFrame': 'Between one and 6 months after hospitalization.', 'description': 'Parents will complete Post-traumatic stress disorder Checklist. We will consider subjects with a score above 44 to be clinically affected by post-traumatic stress disorder.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-traumatic Stress']}, 'descriptionModule': {'briefSummary': 'The elements that promote the development of post-traumatic stress in parents following hospitalization in pediatric resuscitation and thus the options for improving initial care at the time of hospitalization are unknown.\n\nIt is therefore important to describe the prevalence of post-traumatic stress disorder with current pediatric resuscitation management data, but also to possibly describe the factors associated with it in order to optimize initial management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All parents of children aged 0 to 18 who have been admitted in paediatric resuscitation unit.\n\nExclusion Criteria:\n\n* Holders of parental authority who cannot answer the questionnaire because they do not speak French.\n* Opposition of one of the two holders of parental authority\n* Minor parental authority holders\n* Holders of parental authority under safeguarding of justice or guardianship'}, 'identificationModule': {'nctId': 'NCT04648605', 'acronym': 'POETIC', 'briefTitle': 'Post-traumatic Stress Disorder After Pediatric Intensive Care Unit Hospitalization', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Post-traumatic Stress Disorder Occurrence in Parents of Neonate and Children Hospitalized in an Intensive Care Unit', 'orgStudyIdInfo': {'id': 'RC31/20/0406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Questionary', 'description': 'Questionary for all parents', 'interventionNames': ['Other: Post traumatic stress disorder questionnaire']}], 'interventions': [{'name': 'Post traumatic stress disorder questionnaire', 'type': 'OTHER', 'description': 'Parents of hospitalized children in pediatric resuscitation carry out a validated questionnaire that validates the post-traumatic stress level by a score.', 'armGroupLabels': ['Questionary']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Sophie BREINIG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}