Mechanical Cough Augmentation in Children With NMD

Cough Clinical Trial

Official title:

Prevalence and Use of Mechanical Cough Augmentation in Children With Neuromuscular Disorders in Norway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831568
• Other study ID #: MIE 2016_14321
• Secondary ID: 17/9232Hov_2017
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: September 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria: ,

• Received a MI-E device

• Neuromuscular disease

• < 18 years

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Airway Clearance Impairment
• Children, Only
• Cough
• Neuromuscular Diseases

Locations

Country	Name	City	State
Norway	Oslo university hospital	Oslo

Sponsors (6)

Lead Sponsor	Collaborator
Oslo University Hospital	Haukeland University Hospital, Helse Stavanger HF, Sorlandet Hospital HF, St. Olavs Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residency	Name of county	At one point (1 day)
Primary	Indication for use	Prevention or treatment purposes from questionnaire	At one point (1 day)
Primary	Diagnosis	International Classification of Diseases - 10 diagnosis	01.01.2018
Secondary	Health related quality of life	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.	One time at completion of questionaire
Secondary	Settings in use	Recorded from data card in MIE machine	One time at completion of questionaire
Secondary	Opinion on treatment	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.	One time at completion of questionaire