Mechanical Cough Augmentation in Children With NMD
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|ClinicalTrials.gov Identifier: NCT03831568|
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : September 6, 2019
|Condition or disease|
|Neuromuscular Diseases Children, Only Airway Clearance Impairment Cough|
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 :||Observational [Patient Registry]|
|Actual Enrollment :||72 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Prevalence and Use of Mechanical Cough Augmentation in Children With Neuromuscular Disorders in Norway|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||January 31, 2019|
|Actual Study Completion Date :||January 31, 2019|
|Children with given device for mechanical cough|
- Residency [ Time Frame: At one point (1 day) ]Name of county
- Indication for use [ Time Frame: At one point (1 day) ]Prevention or treatment purposes from questionnaire
- Diagnosis [ Time Frame: 01.01.2018 ]International Classification of Diseases - 10 diagnosis
- 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.
- Settings in use [ Time Frame: One time at completion of questionaire ]Recorded from data card in MIE machine
- Opinion on treatment [ Time Frame: One time at completion of questionaire ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831568
|Oslo university hospital|
|Principal Investigator:||Vegard Hovland, PhD||MD|