Skip to main content
OpenTrials
Completed

NCT Number: NCT03831568

Mechanical Cough Augmentation in Children With NMD

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuromuscular Diseases Airway Clearance Impairment Children, Only Cough Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo university hospital

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

,

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Residency

    Time frame: At one point (1 day)

    Name of county

  2. Indication for use

    Time frame: At one point (1 day)

    Prevention or treatment purposes from questionnaire

  3. Diagnosis

    Time frame: 01.01.2018

    International Classification of Diseases - 10 diagnosis

Secondary outcomes

  1. 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.

  2. Settings in use

    Time frame: One time at completion of questionaire

    Recorded from data card in MIE machine

  3. 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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Haukeland University Hospital
  • Helse Stavanger HF
  • Sorlandet Hospital HF
  • St. Olavs Hospital
  • University Hospital of North Norway

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2019
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.