Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT06960356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-07
First Post:
2025-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of Follow-up Nursing Consultations for Children at Risk of Post-resuscitation Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-traumatic stress disorder', 'timeFrame': '3 months', 'description': "Prevalence of post-traumatic stress disorder (PTSD) as defined by a standardized assessment of PTSD using the Children's Revised Impact of Event Scale (CRIES-13) scale for children over 7 years of age.\n\nRange from 0 to 80. Higher scores indicate greater post-traumatic stress"}], 'secondaryOutcomes': [{'measure': 'Pediatric Quality of Life Inventory TM (PEDSQL scale)', 'timeFrame': '3 months', 'description': 'assessing Pediatric Quality of Life Inventory TM (PESQL scale) at 3 months in patients admitted to pediatric critical care. Range from 0 to 230.\n\nHigher scores indicate better health related quality of life.'}, {'measure': "correlation between the PTSD score and the child's quality of life", 'timeFrame': '3 months', 'description': "correlation between the post-traumatic stress disorder score (Using Children's Revised Impact of Event Scale - range from 0 to 65 - the higher the score, the greater the impact of the event on the child) and the child's quality of life ( Using Pediatric Quality of Life Inventory TM scale - range from 0 to 230 - higher scores indicate better health-related quality of life)"}, {'measure': 'Measurement of the association between the characteristics of children and their stay in critical care, and the presence of PTSD', 'timeFrame': '3 months', 'description': "Search for factors associated with the onset of PTSD. Measurement of the association between the characteristics of children and their stay in critical care, and the presence of PTSD (using the Children's Revised Impact of event Scale - Range from 0to 65 - the higher the score, the greater the impact of the event on the child)"}, {'measure': 'number of children with significant somatic symptoms', 'timeFrame': '3 months', 'description': 'Estimate the proportion of children presenting significant and disabling somatic symptoms in their lives, requiring referral to the appropriate healthcare professionals.'}, {'measure': 'Screening parents for PTSD', 'timeFrame': '3 months', 'description': 'Screening parents for PTSD using the POst-Traumatic stress disorder checklist version DSM-5 (PCL 5). range from 0 to 80 - the higher the score, the greater the post-traumatic stress'}, {'measure': 'factors associated with the occurrence of PTSD in parents', 'timeFrame': '3 months', 'description': 'Measurement of the association between the characteristics of the children and their stay in critical care, and the presence of PTSD in the parents with Post-Traumatic stress disorder checklist version DSM-5 (PCL 5). range from 0 to 80 - the higher the score, the greater the post-traumatic stress'}, {'measure': 'Evaluate the feasibility of having the follow-up critical care consultation carried out by a nursery nurse', 'timeFrame': '3 months', 'description': 'time devoted to organising and carrying out consultations and referrals, number and proportion of parents who do not attend consultations (parental involvement)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Disorder, Post Traumatic']}, 'descriptionModule': {'briefSummary': 'The investigator hypothesize that, during an IPDE consultation 3 months after discharge from critical care, the investigator will identify PTSD in approximately one-third of children, and show an association between this syndrome and quality of life in children admitted to pediatric intensive care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 1 and 17.5 years at inclusion\n* Having stayed in a paediatric intensive care unit in one of the 2 participating centers: Lyon or Grenoble\n* Requiring mechanical ventilation (invasive or non-invasive) for more than 24 hours\n\nExclusion Criteria:\n\n* Patients already under the care of a psychologist or psychiatrist\n* patients who died during their stay in intensive care\n* Patients who died between discharge and 3 months\n* Patients suspected of abuse\n* Patient and/or parent refusal to participate\n* No social security affiliation\n* Patients / parents who do not speak French'}, 'identificationModule': {'nctId': 'NCT06960356', 'acronym': 'SURVIPED', 'briefTitle': 'Development of Follow-up Nursing Consultations for Children at Risk of Post-resuscitation Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Development of Follow-up Nursing Consultations for Children at Risk of Post-resuscitation Syndrome', 'orgStudyIdInfo': {'id': '38RC24.0249'}, 'secondaryIdInfos': [{'id': '2024-A01670-47', 'type': 'OTHER', 'domain': 'RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'screening for post-resuscitation syndrome', 'interventionNames': ['Other: detect post-traumatic stress disorder']}], 'interventions': [{'name': 'detect post-traumatic stress disorder', 'type': 'OTHER', 'description': 'recommendation for follow-up by a professional specializing in child development and/or a complementary medical consultation', 'armGroupLabels': ['screening for post-resuscitation syndrome']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alice FUMAGALLI, PDE', 'role': 'CONTACT', 'email': 'AFumagalli@chu-grenoble.fr', 'phone': '0676765503', 'phoneExt': '+33'}, {'name': 'Guillaume MORTAMET, PHD', 'role': 'CONTACT', 'email': 'Gmortamet@chu-grenoble.fr', 'phone': '0476765503', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}