BronchiolitisNCT04260919
Chest Physiotherapy in Bronchiolitis
A study testing Chest physiotherapy in people with Bronchiolitis, run by Universidade do Porto.
Trial summary
Randomized trial of chest physiotherapy in outpatients with bronchiolitis under two years of age, during two consecutive seasonal outbreaks. Read more about this study
- Who is it for?
- Ages 15 days to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Chest physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Mar 2012
- 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 15 days to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis
Who cannot join
- presence of comorbidities, such as cystic fibrosis, neuromuscular, congenital heart disease, prematurity or respiratory distress and all the cases that were admitted into the hospital
About this study
Official title: Chest Physiotherapy in Light and Moderate Bronchiolitis in Ambulatory Children Under Two Years of Age - a Randomised Control Trial
Randomized trial of chest physiotherapy in outpatients with bronchiolitis under two years of age, during two consecutive seasonal outbreaks.
Read the detailed description
A randomized controlled trial was conducted (following CONSORT Statement) in the Paediatric Emergency Department of Centro Hospitalar Universitário São João-Porto (CHUSJ), a tertiary care hospital, during the period from December to March in 2011 and 2012.
Ethical approval was obtained from the Ethics Committee of Centro Hospitalar Universitário São João-Porto.
Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis based on clinical findings, including wheezing or wheezing with crackles, respiratory distress and alteration of feeding condition, were signalized by the physician who met them at the emergency room.
Then, the main investigator of the study interviewed the caregivers and informed about the aims and procedures of the study, after a formal written consent in accordance with the Declaration of Helsinki was sign by all the caregivers.
Severity grade was established with the Kristjansson Respiratory Score which variate from light to severe, being the light to moderate selected to study.
Randomization in intervention or control group was made by the method of permuted-blocks. All children were assessed in a calm environment, while awake and not crying, and were submitted to a standard assessment protocol consisting of a clinical demographic data collection by interview of parents and the application of the Kristjansson Respiratory Score. All children underwent the same medical treatment protocol at the pediatric emergency department (PED), consisting in nebulization with medication, during the emergency room episode, and counselled in the subsequent one or two weeks and were followed during two weeks after discharge from PED, being reassessed at the end of the two weeks.
Children from Intervention Group (IG) underwent a standard intervention chest physiotherapy protocol performed by a physiotherapist, consisting on the techniques: prolonged slow expiration (PSE), rhinopharyngeal retrograde clearance (RRC) and provoked cough (PC).
- Conditions
- Bronchiolitis
- Being tested
- Chest physiotherapy
- Keywords
- bronchiolitis, chest physiotherapy, children
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest physiotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The participants just received standard medical treatment |
| Intervention | Experimental | The participants received medical treatment and chest physiotherapy sessions Receives: Procedure: Chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Kristjansson Respiratory Score
Verified by changes in the Kristjansson Respiratory Score, which is a practical and simple score, that assesses the main signs and symptoms of bronchiolitis, having a good validity and inter-observer reliability.It assigns a value between 0 and 2 to each of the five variables: respiratory rate, chest recession, breath sound, skin colour and general condition. A higher Kristjansson respiratory score indicate a worse respiratory condition.
Measured: Baseline; after two weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- 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
- Model description
- Randomized trial with two groups.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederico Ramos Pinto, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260919
- Sponsor's protocol ID
- FRP-01
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 37010196Pinto FR, Alexandrino AS, Correia-Costa L, Azevedo I. Ambulatory chest physiotherapy in mild-to-moderate acute bronchiolitis in children under two years of age - A randomized control trial. Hong Kong Physiother J. 2021 Dec;41(2):99-108. doi: 10.1142/S1013702521500098. Epub 2021 Mar 31.
PubMed 34177198
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Physiotherapy in Light and Moderate Bronchiolitis in Ambulatory Children Under Two Years of Age - a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04260919
- Acronym / sponsor ID
- FRP-01
- Conditions
- Bronchiolitis
- Keywords
- bronchiolitis, chest physiotherapy, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Feb 2020 (actual)
- 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.
Randomized trial of chest physiotherapy in outpatients with bronchiolitis under two years of age, during two consecutive seasonal outbreaks.
Detailed description
A randomized controlled trial was conducted (following CONSORT Statement) in the Paediatric Emergency Department of Centro Hospitalar Universitário São João-Porto (CHUSJ), a tertiary care hospital, during the period from December to March in 2011 and 2012.
Ethical approval was obtained from the Ethics Committee of Centro Hospitalar Universitário São João-Porto.
Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis based on clinical findings, including wheezing or wheezing with crackles, respiratory distress and alteration of feeding condition, were signalized by the physician who met them at the emergency room.
Then, the main investigator of the study interviewed the caregivers and informed about the aims and procedures of the study, after a formal written consent in accordance with the Declaration of Helsinki was sign by all the caregivers.
Severity grade was established with the Kristjansson Respiratory Score which variate from light to severe, being the light to moderate selected to study.
Randomization in intervention or control group was made by the method of permuted-blocks. All children were assessed in a calm environment, while awake and not crying, and were submitted to a standard assessment protocol consisting of a clinical demographic data collection by interview of parents and the application of the Kristjansson Respiratory Score. All children underwent the same medical treatment protocol at the pediatric emergency department (PED), consisting in nebulization with medication, during the emergency room episode, and counselled in the subsequent one or two weeks and were followed during two weeks after discharge from PED, being reassessed at the end of the two weeks.
Children from Intervention Group (IG) underwent a standard intervention chest physiotherapy protocol performed by a physiotherapist, consisting on the techniques: prolonged slow expiration (PSE), rhinopharyngeal retrograde clearance (RRC) and provoked cough (PC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial with two groups.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The participants just received standard medical treatment |
| Intervention | Experimental | Procedure: Chest physiotherapyThe participants received medical treatment and chest physiotherapy sessions |
Who may qualify
- Ages
- 15 days to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis
Key exclusion criteria (1 listed)
- presence of comorbidities, such as cystic fibrosis, neuromuscular, congenital heart disease, prematurity or respiratory distress and all the cases that were admitted into the hospital
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 |
|---|---|---|
| Chest physiotherapy | Procedure or surgery | Intervention |
Primary outcome
Reduction of Kristjansson Respiratory Score
Time frame: Baseline; after two weeks of treatment
Verified by changes in the Kristjansson Respiratory Score, which is a practical and simple score, that assesses the main signs and symptoms of bronchiolitis, having a good validity and inter-observer reliability.It assigns a value between 0 and 2 to each of the five variables: respiratory rate, chest recession, breath sound, skin colour and general condition. A higher Kristjansson respiratory score indicate a worse respiratory condition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- 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.
- Derived from this study: PubMed 34177198Pinto FR, Alexandrino AS, Correia-Costa L, Azevedo I. Ambulatory chest physiotherapy in mild-to-moderate acute bronchiolitis in children under two years of age - A randomized control trial. Hong Kong Physiother J. 2021 Dec;41(2):99-108. doi: 10.1142/S1013702521500098. Epub 2021 Mar 31.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Chest physiotherapy in people with Bronchiolitis, run by Universidade do Porto.
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 1 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 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of Kristjansson Respiratory Score (time frame: Baseline; after two weeks of treatment). 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 NCT04260919, which also lists 2 linked publications.
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 21 Mar 2024.