Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-28 @ 8:31 AM
Study NCT ID:
NCT04562935
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2020-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012121', 'term': 'Respiration, Artificial'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of learning disability', 'timeFrame': '2 to 18 years of age', 'description': 'any educational or pedagogical support as reported by parents, more than 9 hours per week'}, {'measure': 'Rate of chronic disease', 'timeFrame': '2-18 years', 'description': 'any disease requiring continued medication and/or medical check-ups'}, {'measure': 'Rate of visual impairment', 'timeFrame': '2-18 years', 'description': 'that cannot be corrected by glasses or blind'}, {'measure': 'Rate of hearing impairment', 'timeFrame': '2-18 years', 'description': 'requiring amplification by hearing aid or deaf'}], 'primaryOutcomes': [{'measure': 'Total difficulty score of the SDQ questionnaire', 'timeFrame': '2 to 18 years of age', 'description': 'Total difficulty score of the Strengths and Difficulties Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Rate of cerebral palsy', 'timeFrame': '2 to 18 years of age', 'description': 'cerebral palsy defined as 2 or higher on the GMFCS-scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurodevelopmental Disorders']}, 'descriptionModule': {'briefSummary': 'This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the PICU of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016.\n\nA link to a questionnaire including the Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment as well as question on current impairments and health, will be sent to parents. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided.', 'detailedDescription': 'This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the pediatric intensive care section of the Department of Neonatology of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016.\n\nThe Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment is web-based an hosted on a safe hospital server. The link will be sent to the universat digital post-box that all Danish citizens use for contact to the public authorities. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided. Furthermore, parents will answer questions on chronic illness, motor and sensory handicap, and special pedagogical support in day care institutions and school.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the PICU of Copenhagen University Hospital between 1st January 2002 to 31st of December 2016\n* Age of admission \\> 28 days, if born \\> 37 + 0 or have reached the gestational age of \\> 40 weeks if the child is premature.\n* Needing ≥ 2 days ventilator support during the PICU stay\n* Valid civil registration number\n\nExlusion criteria:\n\n\\- Death before follow-up'}, 'identificationModule': {'nctId': 'NCT04562935', 'briefTitle': 'Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age', 'orgStudyIdInfo': {'id': 'VD-2019-47'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric intensive care', 'description': 'Children admitted to a pediatric intensive care unit before one year of age and admitted for to days or more and treated with mechanical ventilation and alive at follow', 'interventionNames': ['Other: admission to pediatric intensive care with mechanical ventilation']}], 'interventions': [{'name': 'admission to pediatric intensive care with mechanical ventilation', 'type': 'OTHER', 'description': 'admission to pediatric intensive care with mechanical ventilation', 'armGroupLabels': ['Pediatric intensive care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Gorm Greisen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'gorm greisen, prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Complex personal data, that cannot meaningfully be reduced to a level that will make re-identification possible'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'consultant neonatologist, professor', 'investigatorFullName': 'Gorm Greisen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}