Cough Assist in Bronchiolitis | NCT01757496

Studies
Cough Assist in Bronchiolitis

NCT01757496

Sponsor

University Hospital, Antwerp

Status

Terminated

Last Update Posted

Oct 15, 2018Actual

Enrollment

1Estimated

Phase

Not Applicable

Conditions

Bronchiolitis
Respiratory Syncytial Virus

Interventions

Cough Assist

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulties with patient inclusion

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Oct 10, 2018Actual

Completion Date

Oct 10, 2018Actual

First Submitted Date

Dec 18, 2012

First Submission Date that Met QC Criteria

Dec 22, 2012

First Posted Date

Dec 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2018

Last Update Posted Date

Oct 15, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stijn Verhulst, MD, PhD, University Hospital, AntwerpPrincipal Investigator

Lead Sponsor

University Hospital, AntwerpOTHER

Collaborators

Name	Class
Philips Respironics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

RSV bronchiolitis in children is still associated with significant morbidity and mortality. RSV infection results in increased mucus production, edema and inflammation at the lower airways and impaired mucociliary clearance. Infants and children under the age of 1 year are particularly vulnerable to complications such as atelectasis and secondary bacterial infection. These children often need non-invasive or invasive ventilation. Atelectasis is common in these children because of smaller airways and decreased cough strength. There is still much uncertainty about the treatment of RSV. Treatment consists primarily of supportive therapy such as tube feeding and additional respiratory support if necessary. There is also limited evidence about the use of nebulizers with beta-agonists and/or hypertonic saline.

The cough assist is a mechanical in- and exsufflator used primarily in patients with neuromuscular diseases to augment cough capacity. In these patients, it was demonstrated that the use of assisted cough resulted in a significant decrease in the number of respiratory infections. Moreover, there is evidence that when used in the case of an acute respiratory deterioration such a massive atelectasis, the atelectasis can be corrected and intubation can be avoided. The aim of this study is to investigate if the use of the CoughAssist device in children with RSV bronchiolitis is associated with a better respiratory outcome.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cough Assist	Experimental	These children will receive 2 Cough Assist sessions daily.	Device: Cough Assist
Control group	No Intervention	These children receive standard care but no physiotherapy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cough Assist	Device		Cough Assist	Philips-Respironics Cough Assist E70

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxygen requirement	Number of days needing additional oxygen requirement	This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.

Secondary Outcomes

Measure	Description	Time Frame
Atelectasis	Development of atelectasis	This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Bronchoscopy	Need for bronchoscopy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children between 3 and 18 months admitted to our hospital with a clinical diagnosis of bronchiolitis in the RSV season or with a positive nasopharyngeal aspirate for RSV.

Exclusion Criteria:

Children with congenital cardiac disease.
Children with cystic fibrosis.
Children with reactive airways disease.
Children with neurological impairment including cerebral palsy.
Children with neuromuscular disease.
Children with upper GI surgery.
Children with emphysema.
Children with a known susceptibility to pneumothorax or with a pneumothorax in the past.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

18 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stijn Verhulst, MD, PhD	University Hospital, Antwerp	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antwerp University Hospital		Edegem		2650	Belgium
GZA Sint-Augustinus

Condition Browse Module

MeSH Terms

ID	Term
D001988	Bronchiolitis

Ancestor Terms

ID	Term
D001991	Bronchitis
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases

Browse Leaves

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Browse Branches

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