Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-25 @ 3:59 PM
Study NCT ID:
NCT03831568
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2017-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanical Cough Augmentation in Children With NMD
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Prevalence and Use of Mechanical Cough Augmentation in Children With Neuromuscular Disorders in Norway
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: