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Bronchiolitis | Cough Assist in Bronchiolitis

Bronchiolitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bronchiolitis

Respiratory Syncytial Virus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Cough Assist

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Cough AssistThese children will receive 2 Cough Assist sessions daily.

Control groupThese children receive standard care but no physiotherapy.

Study Status

Unknown status

Start Date: September 2012

Completed Date:

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Oxygen requirement

Secondary Outcome: Atelectasis

Study sponsors, principal investigator, and references

Principal Investigator: Stijn Verhulst, MD, PhD

Lead Sponsor: University Hospital, Antwerp

Collaborator: Philips Respironics

More information:https://clinicaltrials.gov/show/NCT01757496

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