BronchiolitisNCT01757496
Cough Assist in Bronchiolitis
A study testing Cough Assist in people with Bronchiolitis and Respiratory Syncytial Virus, run by University Hospital, Antwerp at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 months
- Conditions the study is for
- Bronchiolitis, Respiratory Syncytial Virus
- What is being tested?
- Cough Assist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesBelgium
- Study dates
- Sep 2012to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Antwerp University Hospital
Edegem, 2650
GZA Sint-Augustinus
Wilrijk, 2620
About this study
Official title: Cough Assist in RSV-bronchiolitis
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.
- Conditions
- Bronchiolitis, Respiratory Syncytial Virus
- Being tested
- Cough Assist
- Keywords
- Bronchiolitis, Respiratory Syncytial Virus, Cough Assist, Physiotherapy
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough AssistDevice
Also called Philips-Respironics Cough Assist E70
| Study group | Role | What they receive |
|---|---|---|
| Cough Assist | Experimental | These children will receive 2 Cough Assist sessions daily. Receives: Device: Cough Assist |
| Control group | No intervention | These children receive standard care but no physiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen requirement
Number of days needing additional oxygen requirement
Measured: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Secondary outcomes (4)
Atelectasis
Development of atelectasis
Measured: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Bronchoscopy
Need for bronchoscopy
Measured: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Hypercapnia
Duration of hypercapnia
Measured: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Hospitalization length
Hospitalization length
Measured: This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startSep 2012
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Why it stopped: Difficulties with patient inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Respironics
- Responsible party
- Principal investigator, Stijn Verhulst, University Hospital, Antwerp
- Investigators
- Stijn Verhulst, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757496
- Sponsor's protocol ID
- UZA-11/44/334
- Status last verified
- Oct 2018
- First submitted
- 18 Dec 2012
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cough Assist in RSV-bronchiolitis
- ClinicalTrials.gov ID
- NCT01757496
- Acronym / sponsor ID
- UZA-11/44/334
- Conditions
- Bronchiolitis, Respiratory Syncytial Virus
- Keywords
- Bronchiolitis, Respiratory Syncytial Virus, Cough Assist, Physiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with patient inclusion
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Philips Respironics
- Study start
- Sep 2012
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cough Assist | Experimental | Device: Cough AssistThese children will receive 2 Cough Assist sessions daily. |
| Control group | No intervention | –These children receive standard care but no physiotherapy. |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cough AssistAlso: Philips-Respironics Cough Assist E70 | Device | Cough Assist |
Primary outcome
Oxygen requirement
Time frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Number of days needing additional oxygen requirement
4 secondary outcomes
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.
Results and safety
The study was stopped early (reason given: Difficulties with patient inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stijn Verhulst, MD, PhD principal investigator
University Hospital, Antwerp
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cough Assist in people with Bronchiolitis and Respiratory Syncytial Virus, run by University Hospital, Antwerp at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties with patient inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen requirement (time frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.