Mechanical Cough Augmentation in Children With NMD

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

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.

Study Overview

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

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: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children with neuromuscular disorder bellow 18 years that has received a machine for MI-E.

Description

Inclusion Criteria: ,

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

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children with given device for mechanical cough

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Settings in use	Recorded from data card in MIE machine	One time at completion of questionaire
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University Hospital of North Norway; Helse Stavanger HF; Haukeland University Hospital; Sorlandet Hospital HF; St. Olavs Hospital
• Investigators: Principal Investigator: Vegard Hovland, PhD, MD

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): January 31, 2019
• Study Completion (ACTUAL): January 31, 2019

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (ACTUAL): February 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Pediatrics; Cough; Airway management; Mechanical insufflation-exsufflation; Neuromuscular diseases
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Neuromuscular Diseases
• 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: No
• Studies a U.S. FDA-regulated device product: No