Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01757496
Other study ID # UZA-11/44/334
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2012
Est. completion date October 10, 2018

Study information

Verified date October 2018
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date October 10, 2018
Est. primary completion date October 10, 2018
Accepts healthy volunteers No
Gender All
Age group 3 Months to 18 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Cough Assist


Locations

Country Name City State
Belgium Antwerp University Hospital Edegem
Belgium GZA Sint-Augustinus Wilrijk

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Antwerp Philips Respironics

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Atelectasis Development of atelectasis This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Secondary Bronchoscopy Need for bronchoscopy This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Secondary Hypercapnia Duration of hypercapnia This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Secondary Hospitalization length Hospitalization length This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days.
See also
  Status Clinical Trial Phase
Recruiting NCT04989114 - Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis N/A
Recruiting NCT06016244 - Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial N/A
Not yet recruiting NCT05902702 - Isotonic Saline for Children With Bronchiolitis N/A
Recruiting NCT02366715 - Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research Phase 3
Terminated NCT02219334 - Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study N/A
Recruiting NCT01944995 - Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis N/A
Terminated NCT02834819 - Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis N/A
Not yet recruiting NCT01414322 - Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients N/A
Completed NCT00369759 - An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants N/A
Completed NCT00347880 - Atrial and Brain Natriuretic Peptides in Bronchiolitis Phase 1
Recruiting NCT05548036 - A Feasibility RCT of Aerobika Verses ACBT in People With COPD N/A
Active, not recruiting NCT04302207 - The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study N/A
Completed NCT02858531 - Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics
Withdrawn NCT05994183 - The Bronchiolitis in Hospitalized Infants Study Early Phase 1
Terminated NCT03614507 - Automation Oxygen Flow Titration in Spontaneously Breathing Infants N/A
Completed NCT02856165 - High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis N/A
Recruiting NCT05909566 - Respiratory Support and Treatment for Efficient and Cost-Effective Care N/A
Recruiting NCT04437641 - Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children
Not yet recruiting NCT06083077 - Chest and Abdominal Wall Strapping in Infant With Bronchiolitis N/A
Recruiting NCT02708147 - Impact of Respiratory Physiotherapy in Children With Bronchiolitis in the First Two Years of Life N/A