BronchiolitisNCT04553822
Mucociliary Clearance Techniques in Moderate Bronchiolitis
A study testing Assisted autogenous drainage group (DAA) and Group prolonged slow expiration (ELPr) in people with Bronchiolitis, run by Guadarrama Hospital at 1 site in Spain.
Trial summary
Acute viral bronchiolitis (BE) is an inflammatory disease of the lower respiratory tract, with a viral etiology, where the respiratory syncytial virus is the most prevalent agent. Read more about this study
- Who is it for?
- Ages 2 to 12 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Assisted autogenous drainage group (DAA) and Group prolonged slow expiration (ELPr)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 6 Apr 2022
- 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 2 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be between 2 and 12 months of age (according to the latest Clinical Practice Guide on BQ of the National Health System available in Spain, it is considered comorbidity to have less than 2 months old)twenty.
- Have a medical diagnosis of a first episode of acute BE.
- Acute BE with a moderate degree of involvement with a score on the Acute Bronchiolitis Severity Scale (ESBA) ≥ 5 and ≤ 9.
- Acute BE with a degree of moderate severity with a modified Wood-Downes Scale (WD-S) score ≥ 4 and ≤ 5.
- Acute BE in a moderate degree of severity with a score according to the Hospital Sant Joan de Déu (HSJD) scale ≥ 6 and ≤ 10.
- Acute BE in a moderate degree of severity with a score on the ReSVinet Scale ( RSV-S) ≥ 7 and ≤ 13.
- Have not previously received respiratory physiotherapy since diagnosis.
- Oxygen saturation (SaO2) ≥ 94%,and j) have the informed consent of the child's legal guardians.
Who cannot join
- Acute BE with a score of ≤ 4 or ≥ 10 according to ESBA.
- Acute BE with a score ≤ 3 or ≥ 6 on the WD-S.
- Acute BE with score ≤ 5 or ≥ 11 in HSJD.
- Acute BE with score ≤ 6 or ≥ 14 in RSV-S, f) SaO2 ≤ 93%.
- Associated congenital heart disease, h ) previous hospitalizations for recurrent wheezing or episode of bronchiolitis requiring admission for more than 48 hours.
- Medical diagnosis of recurrent wheezing.
Show all 10Show fewer
- Failure to follow up at 48 hours.
- No parental consent.
- Premature infants <32- 35 weeks.
- Bronchopulmonary dysplasia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mucociliary Clearance Techniques in Non-hospitalized Moderate Bronchiolitis: a Multicenter Clinical Trial
Acute viral bronchiolitis (BE) is an inflammatory disease of the lower respiratory tract, with a viral etiology, where the respiratory syncytial virus is the most prevalent agent. Respiratory physiotherapy (FTR) aims to remove airway obstruction, which decreases airway resistance, improves gas exchange, and reduces respiratory load. It is widely used in the treatment of children with chronic respiratory disease, but has long been debated as a treatment for bronchiolitis.
The objective of this study is to evaluate the effectiveness of two mucociliary clearance techniques in non-hospitalized children <12 months with a first episode of moderate BE.
This is a clinical trial that aims to recruit patients from 2 to 12 months who attend the Physiobronchial physiotherapy centers in Madrid, A Coruña, and Barcelona with a first-time medical diagnosis of BQ of 48 hours of maximum evolution. Participants will be randomly assigned into 3 groups: Group A: Assisted Autogenous Drainage (DAA), Group B: Prolonged Slow Expiration (ELPr) and Control Group. The main variables are the Acute Bronchiolitis Severity Scale (ESBA), oxygen saturation (SaO2), the modified Wood-Downes scale (WD-S), the Hospital scale Sant Joan de Déu (HSJD) and the ReSVinet Scale (RSV-S), and will be measured by a blinded evaluator at the beginning of the session (T0), 20 minutes after administering short-acting β2 adrenergic agonist (SABA) (T20 ), immediately after nebulization (T40) and at the end of the physiotherapist's intervention (T60). It will be reassessed 48 hours after the session (T48h) and the protocol will be repeated completely if it has not dropped at least two points according to the scales.
Read the detailed description
The main objective of the present work is to evaluate the effectiveness of two mucociliary clearance techniques in non-hospitalized children <12 months with a first episode of moderate BE.
Once each patient legal guardians has signed the informed consent document and it has been verified that the inclusion criteria are met, participants will be assigned the same identification number (ID) that is related to its Clinical History (CH) by simple coding; custody of the file with the relationship of each ID with its CH will be the responsibility of the principal investigator. The method of blinding in the allocation will be performed by choosing opaque sealed envelopes by a person external to the study. The contents of the envelopes will be the random assignment cards to each of the three groups, this simple random numerical sequence will be generated by computer using the R program see 3.5.1. (R Foundation for Statistical Computing,Institute for Statistics and Mathematics, Welthandelsplatz 1, 1020 Vienna, Austria) based on stratified sampling for homogeneity, in three groups:Group A: assisted autogenous drainage group (DAA), group B: group prolonged slow expiration (ELPr), group C: control group (CG).
None of the children that make up both intervention group A and B, and the control group, will be prohibited from the usual pharmacological treatment prescribed by their doctor. It will collect in the investigator's notebook the medications that each patient has prescribed by their doctor. Physiotherapists cannot prescribe drugs, but can administer them at the beginning of the protocol after the prescription by the doctor.
Within the protocol, the short-acting β2 adrenergic agonist (SABA) will be administered, prior to nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer. Next, following protocols will be applied:
- Intervention based on DAA Group A: the technique consists of positioning the patient in a supine position with the head slightly elevated on the supporting plane and then placing both hands around the rib cage and applying bimanual expiratory compression on both hemithoraxes. The physiotherapist must ensure that the child takes 2 to 3 controlled breaths, close to the residual level, with the objective that the expiratory flow displaces the secretions, located distally, towards the central airways.
- Intervention based on ELPr Group B: this technique applied to the baby by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.
- Group C: nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer.
The timing of intervention protocol will be followed: a) The SABA prescribed by the doctor will be administered to all patients; b) 20 minutes later the patient will then receive an 8-minute nebulization of Muconeb® 3% hypertonic solution; c) The treatment techniques protocol will consist of a standard 20 minute session based on nasal washes and the protocols descrive above for each intervention group.
Both groups will receive 3 evaluations by an investigator who will be blinded on the treatment and the objectives. The evaluations will be carried out at the beginning of the session (T0), 20 minutes after the SABA administration (T20), after the nebulization of Muconeb® 3% hypertonic solution (T30), after intervention treatment protocol (T60) and, finially, after 48 hours from ending treatment session (T48).
The main variables will classify the participants according to the initial clinical severity score proposed by the Acute Bronchiolitis Severity Scale (ESBA), the Wood-Downes Scale modified by Ferres (WDF-S), the Scale of the Sant Joan de Déu Hospital (HSJD) and the ReSVinet Scale (RSV-S). HR is a variable that is collected on the HSJD and WDS scales. SaO2 is included in the HSJD and ESBA scale, both will be measured through a pulse oximeter (Radical Touchscreen from Massimo®, Masimo Corporation, Irvine, CA).
- Conditions
- Bronchiolitis
- Being tested
- Assisted autogenous drainage group (DAA), Group prolonged slow expiration (ELPr), Control group (CG)
- Keywords
- Physical Therapy, Respiratory, Pediatric
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted autogenous drainage group (DAA)Other
DAA, is used when the patient is not able to perform this technique autonomously and is assisted by the physiotherapist. Its greatest utility is in infants and preschoolers. The technique consists of positioning the patient in a supine position with the head slightly elevated on the supporting plane and then placing both hands around the rib cage and applying bimanual expiratory compression on both hemithoraxes. The physiotherapist must ensure that the child takes 2 to 3 controlled breaths, close to the residual level, with the objective that the expiratory flow displaces the secretions, located distally, towards the central airways.
Group prolonged slow expiration (ELPr)Other
Passive expiratory aid technique applied to the baby by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.
Control group (CG)Other
Nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer. Once the nebulization is finished, you will wait 30 minutes in a closed room.
| Study group | Role | What they receive |
|---|---|---|
| Assisted autogenous drainage group (DAA) | Experimental | The technique consists of positioning the patient in a supine position with the head slightly elevated on the supporting plane and then placing both hands around the rib cage and applying bimanual expiratory compression on both hemithoraxes. Receives: Other: Assisted autogenous drainage group (DAA) |
| Group prolonged slow expiration (ELPr) | Experimental | This technique is applied to the baby by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. Receives: Other: Group prolonged slow expiration (ELPr) |
| Control group (CG) | Active comparator | Nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer. Receives: Other: Control group (CG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Bronchiolitis Severity Scale
Is a quantitative cumulative scale designed to assess clinical severity in patients with BE. The clinical severity scoring system is made up of five items: wheezing or crackles (only the one with the highest score is taken into account), effort, i / e ratio, RR and HR. Each item is scored from 0 to 4, the values of each item are added and a total result of (0-4) mild, (5-9) moderate and (10-13) severe is obtained, with 13 being the maximum score and 0 the minimum.
Measured: 48 hours
Secondary outcomes (2)
Wood-Downes Scale modified by Ferres (WDF-S)
Measured: 48 hours
Scale of the Sant Joan de Déu Hospital
Is a quantitative cumulative scale designed to assess clinical severity in patients with BE. The clinical severity scoring system is made up of six items: wheezing, drawing, air intake, SaO2 (with and without O2 input), RR and HR. Each item is scored from 0 to 3, the values of each item are added and a total result of (0-5) mild, (6-10) moderate and (11-16) severe is obtained, with 16 being the maximum score and 0 the minimum. A higher clinical score indicates a worse condition.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Nov 2020
- Primary completion6 Mar 2022
- Study completion6 Apr 2022
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
- Single-blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guadarrama Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fisiobronquial Clínicas
- Responsible party
- Principal investigator, J. Nicolas Cuenca Zaldivar, Guadarrama Hospital
- Investigators
- Juan Nicolas Mr Cuenca Zaldívar, Principal investigator, Hospital Guadarrama, servicio de fisioterapia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553822
- Sponsor's protocol ID
- 9.0
- Status last verified
- Jun 2023
- First submitted
- 12 Sep 2020
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez-Bellido V, Rama Suarez N, Yanez Yepez GA, Jimeno Esteo MDC, Garcia Caraballo R, Mayoralas Alises S, Cuenca Zaldivar JN, Donadio MVF, Sanchez Romero EA, Fernandez Carnero S. Effectiveness of airway clearance techniques versus control in non-hospitalized infants with moderate acute viral bronchiolitis: A randomized controlled clinical trial. Clinics (Sao Paulo). 2025 Jan-Dec;80:100735. doi: 10.1016/j.clinsp.2025.100735. Epub 2025 Aug 4.
PubMed 40752047Roque-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 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mucociliary Clearance Techniques in Non-hospitalized Moderate Bronchiolitis: a Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04553822
- Acronym / sponsor ID
- 9.0
- Conditions
- Bronchiolitis
- Keywords
- Physical Therapy, Respiratory, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Guadarrama HospitalUniversity, hospital or other
- Collaborators
- Fisiobronquial Clínicas
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 6 Mar 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 17 Sep 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.
Acute viral bronchiolitis (BE) is an inflammatory disease of the lower respiratory tract, with a viral etiology, where the respiratory syncytial virus is the most prevalent agent. Respiratory physiotherapy (FTR) aims to remove airway obstruction, which decreases airway resistance, improves gas exchange, and reduces respiratory load. It is widely used in the treatment of children with chronic respiratory disease, but has long been debated as a treatment for bronchiolitis.
The objective of this study is to evaluate the effectiveness of two mucociliary clearance techniques in non-hospitalized children <12 months with a first episode of moderate BE.
This is a clinical trial that aims to recruit patients from 2 to 12 months who attend the Physiobronchial physiotherapy centers in Madrid, A Coruña, and Barcelona with a first-time medical diagnosis of BQ of 48 hours of maximum evolution. Participants will be randomly assigned into 3 groups: Group A: Assisted Autogenous Drainage (DAA), Group B: Prolonged Slow Expiration (ELPr) and Control Group. The main variables are the Acute Bronchiolitis Severity Scale (ESBA), oxygen saturation (SaO2), the modified Wood-Downes scale (WD-S), the Hospital scale Sant Joan de Déu (HSJD) and the ReSVinet Scale (RSV-S), and will be measured by a blinded evaluator at the beginning of the session (T0), 20 minutes after administering short-acting β2 adrenergic agonist (SABA) (T20 ), immediately after nebulization (T40) and at the end of the physiotherapist's intervention (T60). It will be reassessed 48 hours after the session (T48h) and the protocol will be repeated completely if it has not dropped at least two points according to the scales.
Detailed description
The main objective of the present work is to evaluate the effectiveness of two mucociliary clearance techniques in non-hospitalized children <12 months with a first episode of moderate BE.
Once each patient legal guardians has signed the informed consent document and it has been verified that the inclusion criteria are met, participants will be assigned the same identification number (ID) that is related to its Clinical History (CH) by simple coding; custody of the file with the relationship of each ID with its CH will be the responsibility of the principal investigator. The method of blinding in the allocation will be performed by choosing opaque sealed envelopes by a person external to the study. The contents of the envelopes will be the random assignment cards to each of the three groups, this simple random numerical sequence will be generated by computer using the R program see 3.5.1. (R Foundation for Statistical Computing,Institute for Statistics and Mathematics, Welthandelsplatz 1, 1020 Vienna, Austria) based on stratified sampling for homogeneity, in three groups:Group A: assisted autogenous drainage group (DAA), group B: group prolonged slow expiration (ELPr), group C: control group (CG).
None of the children that make up both intervention group A and B, and the control group, will be prohibited from the usual pharmacological treatment prescribed by their doctor. It will collect in the investigator's notebook the medications that each patient has prescribed by their doctor. Physiotherapists cannot prescribe drugs, but can administer them at the beginning of the protocol after the prescription by the doctor.
Within the protocol, the short-acting β2 adrenergic agonist (SABA) will be administered, prior to nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer. Next, following protocols will be applied:
- Intervention based on DAA Group A: the technique consists of positioning the patient in a supine position with the head slightly elevated on the supporting plane and then placing both hands around the rib cage and applying bimanual expiratory compression on both hemithoraxes. The physiotherapist must ensure that the child takes 2 to 3 controlled breaths, close to the residual level, with the objective that the expiratory flow displaces the secretions, located distally, towards the central airways.
- Intervention based on ELPr Group B: this technique applied to the baby by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.
- Group C: nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer.
The timing of intervention protocol will be followed: a) The SABA prescribed by the doctor will be administered to all patients; b) 20 minutes later the patient will then receive an 8-minute nebulization of Muconeb® 3% hypertonic solution; c) The treatment techniques protocol will consist of a standard 20 minute session based on nasal washes and the protocols descrive above for each intervention group.
Both groups will receive 3 evaluations by an investigator who will be blinded on the treatment and the objectives. The evaluations will be carried out at the beginning of the session (T0), 20 minutes after the SABA administration (T20), after the nebulization of Muconeb® 3% hypertonic solution (T30), after intervention treatment protocol (T60) and, finially, after 48 hours from ending treatment session (T48).
The main variables will classify the participants according to the initial clinical severity score proposed by the Acute Bronchiolitis Severity Scale (ESBA), the Wood-Downes Scale modified by Ferres (WDF-S), the Scale of the Sant Joan de Déu Hospital (HSJD) and the ReSVinet Scale (RSV-S). HR is a variable that is collected on the HSJD and WDS scales. SaO2 is included in the HSJD and ESBA scale, both will be measured through a pulse oximeter (Radical Touchscreen from Massimo®, Masimo Corporation, Irvine, CA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Single-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Assisted autogenous drainage group (DAA) | Experimental | Other: Assisted autogenous drainage group (DAA)The technique consists of positioning the patient in a supine position with the head slightly elevated on the supporting plane and then placing both hands around the rib cage and applying bimanual expiratory compression on both hemithoraxes. |
| Group prolonged slow expiration (ELPr) | Experimental | Other: Group prolonged slow expiration (ELPr)This technique is applied to the baby by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. |
| Control group (CG) | Active comparator | Other: Control group (CG)Nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer. |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Be between 2 and 12 months of age (according to the latest Clinical Practice Guide on BQ of the National Health System available in Spain, it is considered comorbidity to have less than 2 months old)twenty.
- Have a medical diagnosis of a first episode of acute BE.
- Acute BE with a moderate degree of involvement with a score on the Acute Bronchiolitis Severity Scale (ESBA) ≥ 5 and ≤ 9.
- Acute BE with a degree of moderate severity with a modified Wood-Downes Scale (WD-S) score ≥ 4 and ≤ 5.
- Acute BE in a moderate degree of severity with a score according to the Hospital Sant Joan de Déu (HSJD) scale ≥ 6 and ≤ 10.
Key exclusion criteria (10 listed)
- Acute BE with a score of ≤ 4 or ≥ 10 according to ESBA.
- Acute BE with a score ≤ 3 or ≥ 6 on the WD-S.
- Acute BE with score ≤ 5 or ≥ 11 in HSJD.
- Acute BE with score ≤ 6 or ≥ 14 in RSV-S, f) SaO2 ≤ 93%.
- Associated congenital heart disease, h ) previous hospitalizations for recurrent wheezing or episode of bronchiolitis requiring admission for more than 48 hours.
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 |
|---|---|---|
| Assisted autogenous drainage group (DAA)DAA, is used when the patient is not able to perform this technique autonomously and is assisted by the physiotherapist. Its greatest utility is in infants and preschoolers. The technique consists of positioning the patient in a supine position with the head slightly elevated on the supporting plane and then placing both hands around the rib cage and applying bimanual expiratory compression on both hemithoraxes. The physiotherapist must ensure that the child takes 2 to 3 controlled breaths, close to the residual level, with the objective that the expiratory flow displaces the secretions, located distally, towards the central airways. | Other | Assisted autogenous drainage group (DAA) |
| Group prolonged slow expiration (ELPr)Passive expiratory aid technique applied to the baby by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through the provoked cough or stimulation of the trachea achieves the expectoration of the sputum. | Other | Group prolonged slow expiration (ELPr) |
| Control group (CG)Nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer. Once the nebulization is finished, you will wait 30 minutes in a closed room. | Other | Control group (CG) |
Primary outcome
Acute Bronchiolitis Severity Scale
Time frame: 48 hours
Is a quantitative cumulative scale designed to assess clinical severity in patients with BE. The clinical severity scoring system is made up of five items: wheezing or crackles (only the one with the highest score is taken into account), effort, i / e ratio, RR and HR. Each item is scored from 0 to 4, the values of each item are added and a total result of (0-4) mild, (5-9) moderate and (10-13) severe is obtained, with 13 being the maximum score and 0 the minimum.
2 secondary outcomes
Wood-Downes Scale modified by Ferres (WDF-S)
Time frame: 48 hours
Scale of the Sant Joan de Déu Hospital
Time frame: 48 hours
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 7 Jun 2023.
- Derived from this study: PubMed 40752047Gonzalez-Bellido V, Rama Suarez N, Yanez Yepez GA, Jimeno Esteo MDC, Garcia Caraballo R, Mayoralas Alises S, Cuenca Zaldivar JN, Donadio MVF, Sanchez Romero EA, Fernandez Carnero S. Effectiveness of airway clearance techniques versus control in non-hospitalized infants with moderate acute viral bronchiolitis: A randomized controlled clinical trial. Clinics (Sao Paulo). 2025 Jan-Dec;80:100735. doi: 10.1016/j.clinsp.2025.100735. Epub 2025 Aug 4.
- 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.
Juan Nicolas Mr Cuenca Zaldívar principal investigator
Hospital Guadarrama, servicio de fisioterapia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted autogenous drainage group (DAA) and Group prolonged slow expiration (ELPr) in people with Bronchiolitis, run by Guadarrama Hospital at 1 site in Spain.
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 8 inclusion and 10 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 7 Jun 2023. 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 Spain. 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 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?
Acute Bronchiolitis Severity Scale (time frame: 48 hours). 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 NCT04553822, 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 7 Jun 2023; AzTrials last refreshed its copy on 30 Oct 2026.