Overview

This trial is active, not recruiting.

Conditions bronchiolitis, respiratory syncytial virus
Treatment cough assist
Sponsor University Hospital, Antwerp
Collaborator Philips Respironics
Start date September 2012
End date December 2017
Trial size 20 participants
Trial identifier NCT01757496, UZA-11/44/334

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
These children will receive 2 Cough Assist sessions daily.
cough assist Philips-Respironics Cough Assist E70
(No Intervention)
These children receive standard care but no physiotherapy.

Primary Outcomes

Measure
Oxygen requirement
time frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.

Secondary Outcomes

Measure
Atelectasis
time frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Bronchoscopy
time frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Hypercapnia
time frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Hospitalization length
time frame: This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days.

Eligibility Criteria

Male or female participants from 3 months up to 18 months old.

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.

Additional Information

Official title Cough Assist in RSV-bronchiolitis
Principal investigator Stijn Verhulst, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University Hospital, Antwerp.