Mechanical Cough Augmentation in Children With NMD

Completed

• Conditions: Children, Only; Airway Clearance Impairment; Neuromuscular Diseases; Cough

• Registration Number: NCT03831568
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-11-27
• Study Start: 2018-01-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

,

• Received a MI-E device
• Neuromuscular disease
• < 18 years

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Indication for use	At one point (1 day)	Prevention or treatment purposes from questionnaire
Diagnosis	01.01.2018	International Classification of Diseases - 10 diagnosis
Residency	At one point (1 day)	Name of county

Secondary Outcome Measures

Name	Time	Method
Opinion on treatment	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.
Settings in use	One time at completion of questionaire	Recorded from data card in MIE machine
Health related quality of life	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.

Trial Locations

Locations (1)

Oslo university hospital; 🇳🇴 Oslo, Norway