Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-02-22 @ 8:35 AM
Study NCT ID:
NCT03831568
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2017-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Cough Augmentation in Children With NMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-04', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2019-02-04', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residency', 'timeFrame': 'At one point (1 day)', 'description': 'Name of county'}, {'measure': 'Indication for use', 'timeFrame': 'At one point (1 day)', 'description': 'Prevention or treatment purposes from questionnaire'}, {'measure': 'Diagnosis', 'timeFrame': '01.01.2018', 'description': 'International Classification of Diseases - 10 diagnosis'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life', 'timeFrame': 'One time at completion of questionaire', 'description': 'The DISABKIDS Chronic Generic Module (DCGM-37) is a questionnaire measuring general health-related quality of life (HRQoL) and the level of distress caused by a chronic disease at 3 domains (mental, social and physical) in 6 dimensions: Independence, Emotion, Social inclusion, Social exclusion, Limitation and Treatment. Each item is scored on a five-point Likert scale which indicates behavior or feelings as 1 = never, 2 = seldom, 3 = quite often, 4 = very often and 5 = always. There is one form to be filled in by children 8 to 18 years of age, and one form by their parents. The sum of scores within each dimension makes up the raw score, which is transformed linearly into a score ranging from 0 to 100. The scores are added and further transformed into a total HRQOL score with a range 0 to 100 with higher scores indicating higher HRQOL.'}, {'measure': 'Settings in use', 'timeFrame': 'One time at completion of questionaire', 'description': 'Recorded from data card in MIE machine'}, {'measure': 'Opinion on treatment', 'timeFrame': 'One time at completion of questionaire', 'description': 'A purpose made questionnaire including questions with predefined categorical data in no order, and 2 questions using a Visual Analog Scale 0-10 to score perceived benefit of the treatment where 0 indicates not important at all and 10 indicates very important.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Airway management', 'Cough', 'Neuromuscular diseases', 'Pediatrics', 'Mechanical insufflation-exsufflation'], 'conditions': ['Neuromuscular Diseases', 'Children, Only', 'Airway Clearance Impairment', 'Cough']}, 'descriptionModule': {'briefSummary': 'The study investigates the prevalence and use of mechanical insufflation - exsufflation (MI-E) in children with Neuromuscular disorders (NMD) in Norway. The NMD related prevalence of MIE use in Norway will be described and possible regional differences regarding use will be assessed.', 'detailedDescription': 'Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan conditions. Respiratory tract infections and lung complications are the main causes of increased morbidity and mortality.\n\nThe use of mechanical cough augmentation with insufflation-exsufflation (MIE) is a strategy to treat and prevent. Possible major benefits are described, but optimal settings for best efficacy and comfort in children are not established.\n\nThe main objective is to determine the prevalence and use of MIE among children with NMD in Norway. All children with NMD \\< 18 years which has received a machine for MI-E will be invited to participate in the study.\n\nThe participants will be asked to complete two questionnaires. In addition will information from the data card in the MI-E machines give information about use. The information will be linked to the National register for Long term mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with neuromuscular disorder bellow 18 years that has received a machine for MI-E.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: ,\n\n* Received a MI-E device\n* Neuromuscular disease\n* \\< 18 years\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT03831568', 'briefTitle': 'Mechanical Cough Augmentation in Children With NMD', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Prevalence and Use of Mechanical Cough Augmentation in Children With Neuromuscular Disorders in Norway', 'orgStudyIdInfo': {'id': 'MIE 2016_14321'}, 'secondaryIdInfos': [{'id': '17/9232', 'type': 'REGISTRY', 'domain': 'NPR'}, {'id': 'Hov_2017', 'type': 'REGISTRY', 'domain': 'NR LTMV'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with given device for mechanical cough'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo university hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Vegard Hovland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of North Norway', 'class': 'OTHER'}, {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist, MSc', 'investigatorFullName': 'Brit Hov', 'investigatorAffiliation': 'Oslo University Hospital'}}}}