- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03831568
Mechanical Cough Augmentation in Children With NMD
Prevalence and Use of Mechanical Cough Augmentation in Children With Neuromuscular Disorders in Norway
Study Overview
Status
Detailed Description
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.
The 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.
The 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.
The 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oslo, Norway
- Oslo University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria: ,
- Received a MI-E device
- Neuromuscular disease
- < 18 years
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Children with given device for mechanical cough
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Residency
Time Frame: At one point (1 day)
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Name of county
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At one point (1 day)
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Indication for use
Time Frame: At one point (1 day)
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Prevention or treatment purposes from questionnaire
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At one point (1 day)
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Diagnosis
Time Frame: 01.01.2018
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International Classification of Diseases - 10 diagnosis
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01.01.2018
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life
Time Frame: One time at completion of questionaire
|
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.
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One time at completion of questionaire
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Settings in use
Time Frame: One time at completion of questionaire
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Recorded from data card in MIE machine
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One time at completion of questionaire
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Opinion on treatment
Time Frame: One time at completion of questionaire
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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.
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One time at completion of questionaire
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vegard Hovland, PhD, MD
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIE 2016_14321
- 17/9232 (REGISTRY: NPR)
- Hov_2017 (REGISTRY: NR LTMV)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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