Trial record 4 of 58 for:    Open Studies | "Bronchiolitis"

Cough Assist in Bronchiolitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Hospital, Antwerp
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
Stijn Verhulst, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01757496
First received: December 18, 2012
Last updated: December 22, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Bronchiolitis
Respiratory Syncytial Virus
Device: Cough Assist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cough Assist in RSV-bronchiolitis

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Oxygen requirement [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ] [ Designated as safety issue: No ]
    Number of days needing additional oxygen requirement


Secondary Outcome Measures:
  • Atelectasis [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ] [ Designated as safety issue: No ]
    Development of atelectasis

  • Bronchoscopy [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ] [ Designated as safety issue: No ]
    Need for bronchoscopy

  • Hypercapnia [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ] [ Designated as safety issue: No ]
    Duration of hypercapnia

  • Hospitalization length [ Time Frame: This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days. ] [ Designated as safety issue: No ]
    Hospitalization length


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cough Assist
These children will receive 2 Cough Assist sessions daily.
Device: Cough Assist
Other Name: Philips-Respironics Cough Assist E70
No Intervention: Control group
These children receive standard care but no physiotherapy.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757496

Contacts
Contact: Stijn Verhulst, MD, PhD +3228213251 stijn.verhulst@uza.be

Locations
Belgium
Antwerp University Hospital Recruiting
Edegem, Belgium, 2650
Contact: Stijn Verhulst, MD, PhD    +3228213251    stijn.verhulst@uza.be   
Principal Investigator: Stijn Verhulst, MD, PhD         
Sponsors and Collaborators
University Hospital, Antwerp
Philips Respironics
Investigators
Principal Investigator: Stijn Verhulst, MD, PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Stijn Verhulst, MD, PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01757496     History of Changes
Other Study ID Numbers: UZA-11/44/334
Study First Received: December 18, 2012
Last Updated: December 22, 2012
Health Authority: Institutional Review Board: Belgium
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
Bronchiolitis
Respiratory Syncytial Virus
Cough Assist
Physiotherapy

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 22, 2014