Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-29 @ 9:18 AM
Study NCT ID:
NCT06172868
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-15
First Post:
2022-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Ventilatory Support in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2022-08-08', 'studyFirstSubmitQcDate': '2023-12-14', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient demographics of patients from 0 up to 16 years old treated by a multidisciplinary home respiratory support-team during January 2010 to December 2020 in Tampere University Hospital, Finland', 'timeFrame': '2022-2023', 'description': 'Data included patient demographics'}, {'measure': 'Number of patients with clinical characteristics', 'timeFrame': '2022-2023', 'description': 'Data included underlying medical conditions and medications. The circumstances for home respiratory support onset, frequency of follow-up, complications, operative interventions to treat sleep apnea before and during period with home respiratory support were collected. The type of respiratory support (device, mode, interface) was recorded.'}], 'secondaryOutcomes': [{'measure': 'The duration of treatment', 'timeFrame': '2022-2023', 'description': 'The duration of treatment during January 2010 to December 2020 in Tampere University Hospital, Finland were collected.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnea Syndromes in Children']}, 'descriptionModule': {'briefSummary': "The study consist of children, who have used home ventilatory support during years 2010-2020 in Tampere University Hospital. The study will describe retrospectively different diagnoses and symptoms which will lead to home ventilatory support. We also study compliance to treatment and it's disanvantages. The prospective part of the study describes the quality of live of these children by using questionnaires (PedSQL)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '93 patients treated by a multidisciplinary paediatric home ventilatory support -team from January 2010 to December 2020 in Tampere University Hospital. The individuals were identified combining two sources: the team´s clinical list of patients and a database search from patient records with ICD-10 diagnose G47.3 (Sleep Apnea) in Pediatric Patient records.', 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- ICD-10 Code for Sleep apnea diagnose G47.3 AND G47.3 diagnose found from pediatric electronic patient records between years 2010-2020 OR Patient name found from pediatric multidisciplinary home respiratory team's clinical list\n\nExclusion Criteria:\n\n* Age over 16\n* Patient starting home ventilation after 31st December 2020 or treatment ending before 1st January 2010\n* patients with sleep apnea but without home respiratory support treatment\n* Only theophylline treatment\n* High-flow oxygen therapy\n* Age over 16 at treatment onset\n* Never started treatment\n* Treatment starting point and ending before year 2010"}, 'identificationModule': {'nctId': 'NCT06172868', 'briefTitle': 'Home Ventilatory Support in Children', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Home Ventilatory Support in Children', 'orgStudyIdInfo': {'id': 'R210861'}}, 'contactsLocationsModule': {'locations': [{'zip': '60720', 'city': 'Ilmajoki', 'country': 'Finland', 'facility': 'Mervi Järvelä', 'geoPoint': {'lat': 62.73333, 'lon': 22.56667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}