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 : February 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 ]DisabKids HRQoL questionnaire
- 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 ]From self-made questionnaire
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|