Mechanical Cough Augmentation in Children With NMD

NCT ID: NCT03831568

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Neuromuscular Diseases Children, Only Airway Clearance Impairment Cough

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with given device for mechanical cough

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Received a MI-E device
* Neuromuscular disease
* \< 18 years

Exclusion Criteria

\- None
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of North Norway

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brit Hov

Physiotherapist, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vegard Hovland, PhD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

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Oslo university hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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17/9232

Identifier Type: REGISTRY

Identifier Source: secondary_id

Hov_2017

Identifier Type: REGISTRY

Identifier Source: secondary_id

MIE 2016_14321

Identifier Type: -

Identifier Source: org_study_id

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