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Mechanical Cough Augmentation in Children With NMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03831568
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : September 6, 2019
University Hospital of North Norway
St. Olavs Hospital
Haukeland University Hospital
Helse Stavanger HF
Sorlandet Hospital HF
Information provided by (Responsible Party):
Brit Hov, 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.

Condition or disease
Neuromuscular Diseases Children, Only Airway Clearance Impairment Cough

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 72 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Children with given device for mechanical cough

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with neuromuscular disorder bellow 18 years that has received a machine for MI-E.

Inclusion Criteria: ,

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

Exclusion Criteria:

- None

Information from the National Library of Medicine

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 identifier (NCT number): NCT03831568

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Oslo university hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
University Hospital of North Norway
St. Olavs Hospital
Haukeland University Hospital
Helse Stavanger HF
Sorlandet Hospital HF
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Principal Investigator: Vegard Hovland, PhD MD

Additional Information:

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Responsible Party: Brit Hov, Physiotherapist, MSc, Oslo University Hospital Identifier: NCT03831568    
Other Study ID Numbers: MIE 2016_14321
17/9232 ( Registry Identifier: NPR )
Hov_2017 ( Registry Identifier: NR LTMV )
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brit Hov, Oslo University Hospital:
Airway management
Neuromuscular diseases
Mechanical insufflation-exsufflation
Additional relevant MeSH terms:
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Neuromuscular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Nervous System Diseases