BronchiolitisNCT02126748
The Effectiveness of AAD and IPV to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis.
A study testing inhalation 4ml hypertonic saline 3% 3x/day, Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in people with Bronchiolitis, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The purpose of this study is to investigate the effectiveness of two airway clearance techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in hospitalized infants under the age of 2 with acute viral bronchiolitis. Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- inhalation 4ml hypertonic saline 3% 3x/day, Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- first period of wheezing
- Wang score between 3 and 7
- age < 24 months
- Sa02> 90%
Who cannot join
- ICU patients
- mechanical ventilation
- use of antibiotics
- use of corticosteroids
- gestational age < 34 weeks
- chronic cardiac or pulmonary disease
- no parental consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Assisted Autogenic Drainage (AAD) and Intrapulmonary Percussive Ventilation (IPV) to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis: a Randomised Clinical Trial.
The purpose of this study is to investigate the effectiveness of two airway clearance techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in hospitalized infants under the age of 2 with acute viral bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- inhalation 4ml hypertonic saline 3% 3x/day, Intrapulmonary Percussive Ventilation, Assisted Autogenic Drainage
- Keywords
- bronchiolitis, Wang score, Sa02, airway clearance techniques, intrapulmonary percussive ventilation, assisted autogenic drainage
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhalation 4ml hypertonic saline 3% 3x/dayOther
Intrapulmonary Percussive VentilationDevice
Assisted Autogenic DrainageProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intrapulmonary Percussive Ventilation | Experimental | 20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day Receives: Other: inhalation 4ml hypertonic saline 3% 3x/day; Device: Intrapulmonary Percussive Ventilation |
| Assisted Autogenic Drainage | Active comparator | 20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day Receives: Other: inhalation 4ml hypertonic saline 3% 3x/day; Procedure: Assisted Autogenic Drainage |
| control | No intervention | 20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2)
Measured: 6 days
Secondary outcomes (3)
Wang Score
Measured: before treatment, immediately after treatment and 1h after treatment
Heartrate
Measured: before, after and 1h after intervention
Oxygen Saturation (SaO2)
oxygen saturation (SaO2) measured by pulse -oximetry
Measured: before, after and 1h after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startDec 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Van Ginderdeuren, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126748
- Sponsor's protocol ID
- FVG003
- Status last verified
- Mar 2015
- First submitted
- 24 Apr 2014
- Last updated
- 11 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.
PubMed 37010196
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Assisted Autogenic Drainage (AAD) and Intrapulmonary Percussive Ventilation (IPV) to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis: a Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT02126748
- Acronym / sponsor ID
- FVG003
- Conditions
- Bronchiolitis
- Keywords
- bronchiolitis, Wang score, Sa02, airway clearance techniques, intrapulmonary percussive ventilation, assisted autogenic drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Posted 11 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effectiveness of two airway clearance techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in hospitalized infants under the age of 2 with acute viral bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intrapulmonary Percussive Ventilation | Experimental | Other: inhalation 4ml hypertonic saline 3% 3x/day, Device: Intrapulmonary Percussive Ventilation20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day |
| Assisted Autogenic Drainage | Active comparator | Other: inhalation 4ml hypertonic saline 3% 3x/day, Procedure: Assisted Autogenic Drainage20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day |
| control | No intervention | –20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- first period of wheezing
- Wang score between 3 and 7
- age < 24 months
- Sa02> 90%
Key exclusion criteria (7 listed)
- ICU patients
- mechanical ventilation
- use of antibiotics
- use of corticosteroids
- gestational age < 34 weeks
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 |
|---|---|---|
| inhalation 4ml hypertonic saline 3% 3x/day | Other | Assisted Autogenic Drainage, Intrapulmonary Percussive Ventilation |
| Intrapulmonary Percussive Ventilation | Device | Intrapulmonary Percussive Ventilation |
| Assisted Autogenic Drainage | Procedure or surgery | Assisted Autogenic Drainage |
Primary outcome
Length of Hospital Stay
Time frame: 6 days
Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2)
3 secondary outcomes
Wang Score
Time frame: before treatment, immediately after treatment and 1h after treatment
Heartrate
Time frame: before, after and 1h after intervention
Oxygen Saturation (SaO2)
Time frame: before, after and 1h after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37010196Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inhalation 4ml hypertonic saline 3% 3x/day, Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in people with Bronchiolitis, run by Vrije Universiteit Brussel at 1 site 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 11 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Length of Hospital Stay (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126748, which also lists 1 linked publication.
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 11 Mar 2015.