Acute Viral BronchiolitisBVA-RESPNCT07682844
Respiratory Physiotherapy and Hospitalization in Infants With Bronchiolitis
A study testing Outpatient Respiratory Physiotherapy in people with Acute Viral Bronchiolitis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Acute Viral Bronchiolitis (AVB) is one of the leading causes of respiratory illness and hospitalization among infants during the first year of life, generating a substantial burden on healthcare services and public health expenditures. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Acute Viral Bronchiolitis
- What is being tested?
- Outpatient Respiratory Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged 12 months or younger.
- Clinical diagnosis of acute viral bronchiolitis.
- Mild or moderate bronchiolitis according to clinical assessment and Wang Bronchiolitis Severity Score.
- Initial evaluation performed at a participating emergency care unit (UPA).
- Parent or legal guardian able and willing to provide informed consent for participants receiving direct physiotherapy care.
Who cannot join
- Severe bronchiolitis requiring immediate hospitalization or emergency medical intervention.
- Infants who did not follow the predefined clinical care pathway (e.g., no initial evaluation at a participating emergency care unit).
- Absence of a clinical diagnosis of acute viral bronchiolitis by the attending pediatrician.
- Any medical condition that, in the opinion of the clinical team, would make participation inappropriate or interfere with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
School of Public Health, University of São Paulo (USP), São Paulo, Brazil
São Paulo, São Paulo, 01246-904
Fredi Alexander D Quijano, PhD, +55 11 946590193, frediazq@usp.br
About this study
Official title: Impact of Outpatient Respiratory Physiotherapy on Hospitalizations and Costs in Infants With Acute Viral Bronchiolitis: A Quasi-Experimental Study in Public Health Services in Sorocaba.
Acute Viral Bronchiolitis (AVB) is one of the leading causes of respiratory illness and hospitalization among infants during the first year of life, generating a substantial burden on healthcare services and public health expenditures. Despite the widespread use of respiratory physiotherapy in clinical practice, there is limited evidence regarding its effectiveness in preventing hospital admissions when provided in an outpatient setting.
This quasi-experimental study aims to evaluate the impact of an outpatient respiratory physiotherapy protocol on hospitalization rates among infants up to 12 months of age diagnosed with mild to moderate acute viral bronchiolitis in the public healthcare system of Sorocaba, Brazil. Infants referred for respiratory physiotherapy will be compared with a similar group of infants who receive standard medical care without physiotherapy referral.
Read more
The physiotherapy protocol includes slow expiratory techniques, rhinopharyngeal retrograde clearance, cough stimulation, and continuous positive airway pressure (CPAP) when clinically indicated. Participants will be followed through medical records and telephone monitoring.
The primary outcome is hospital admission due to bronchiolitis. Secondary outcomes include length of hospital stay, healthcare costs, and clinical evolution. The findings may provide evidence on whether outpatient respiratory physiotherapy can reduce hospitalizations and optimize healthcare resource utilization in infants with acute viral bronchiolitis.
Read the detailed description
Acute Viral Bronchiolitis (AVB) is the most common lower respiratory tract infection in infants and one of the leading causes of emergency department visits and hospital admissions during the first year of life. The disease imposes a substantial burden on healthcare systems, particularly during seasonal epidemics, resulting in increased healthcare utilization and costs.
Although respiratory physiotherapy is frequently used in clinical practice, its role in the management of bronchiolitis remains controversial. Most available studies have focused on hospitalized infants and have shown inconsistent results regarding clinically relevant outcomes. Furthermore, evidence regarding the effectiveness of respiratory physiotherapy in outpatient settings is scarce, and little is known about its potential impact on hospital admission rates and healthcare costs.
This study will be conducted in the public healthcare network of Sorocaba, São Paulo, Brazil, and is designed as a quasi-experimental study intended to emulate a clinical trial under real-world conditions. Infants up to 12 months of age diagnosed with mild or moderate acute viral bronchiolitis in participating emergency care units will be included. Participants referred for outpatient respiratory physiotherapy will constitute the intervention group, while infants with similar clinical characteristics who are not referred for physiotherapy will serve as the comparison group.
The respiratory physiotherapy protocol will include slow expiratory techniques, rhinopharyngeal retrograde clearance, cough stimulation, and continuous positive airway pressure (CPAP) when clinically indicated. Clinical assessment and treatment decisions will be based on standardized evaluation procedures and disease severity classification using the Wang Bronchiolitis Severity Score.
Data will be obtained from electronic medical records, physiotherapy records, and follow-up telephone contacts. The study aims to generate evidence regarding the effectiveness of outpatient respiratory physiotherapy in reducing healthcare utilization and improving the management of infants with acute viral bronchiolitis within a public healthcare system.
- Conditions
- Acute Viral Bronchiolitis
- Being tested
- Outpatient Respiratory Physiotherapy
- Keywords
- Child, Bronchiolitis, SUS, Hospitalization, Respiratory Therapy, Ambulatory Care, Public Health
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Respiratory PhysiotherapyProcedure or surgery
Also called Chest Physiotherapy, Respiratory Therapy, Airway Clearance Techniques
Participants will receive an outpatient respiratory physiotherapy protocol for the management of mild to moderate acute viral bronchiolitis. The intervention may include Prolonged Slow Expiration, Slow Expiratory Flow Increase, Rhinopharyngeal Retrograde Clearance, cough stimulation, and continuous positive airway pressure (CPAP) when clinically indicated. Treatment will be individualized according to the infant's clinical condition, respiratory assessment findings, and bronchiolitis severity as determined by the Wang Bronchiolitis Severity Score. Sessions will be performed by trained physiotherapists and repeated as necessary based on clinical progression until discharge from physiotherapy follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Respiratory Physiotherapy | Experimental | Infants diagnosed with mild to moderate acute viral bronchiolitis who are referred for outpatient respiratory physiotherapy. The intervention may include slow expiratory techniques, rhinopharyngeal retrograde clearance, cough stimulation, and continuous positive airway pressure (CPAP) when clinically indicated, according to a standardized physiotherapy protocol. Receives: Procedure: Outpatient Respiratory Physiotherapy |
| Standard Care Group | No intervention | Infants diagnosed with mild to moderate acute viral bronchiolitis who receive standard medical care through the municipal healthcare system. Outcome data will be obtained from routine clinical records. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization Prevention
Proportion of infants with acute viral bronchiolitis who do not require hospital admission after outpatient physiotherapy management.
Measured: during the hospitalization period (up to 15 days)
Secondary outcomes (1)
costs from the Brazilian public healthcare system perspective
Direct costs related to hospital admissions among infants with acute viral bronchiolitis, including hospitalization expenses and healthcare resource utilization.
Measured: during the period of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start8 Aug 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Viral 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a quasi-experimental, parallel-group study designed to emulate a clinical trial under real-world healthcare conditions. Infants diagnosed with mild to moderate acute viral bronchiolitis will be allocated to study groups according to the clinical care pathway. The intervention group will consist of infants referred for outpatient respiratory physiotherapy, while the comparison group will include infants with similar clinical characteristics who are not referred for physiotherapy. Participants will be analyzed according to the intention-to-treat principle, based on referral status regardless of treatment adherence or completion.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franciny Nunes Dantas Novaes, University of Sao Paulo
- Investigators
- Fredi Alexander D Quijano, PhD, Study chair, School of Public Health, University of São Paulo (USP), São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682844
- Sponsor's protocol ID
- BVA_FISIO_SOROCABA_2026
- Acronym
- BVA-RESP
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves identifiable health information from infants obtained through medical records and follow-up contacts. Although the data will be anonymized for analysis, no data-sharing plan has been established, in accordance with institutional policies and ethical requirements to protect participant confidentiality.
Publications
Ghazaly M, Nadel S. Characteristics of children admitted to intensive care with acute bronchiolitis. Eur J Pediatr. 2018 Jun;177(6):913-920. doi: 10.1007/s00431-018-3138-6. Epub 2018 Apr 13.
PubMed 29654399Ballardini E, Manfrini M, Fattori S, Pellacani E, Cosic B, Gargano G, Berardi A. Hospitalizations for bronchiolitis among infants before and after the SARS-CoV-2 pandemic: an area-based study of the Emilia-Romagna Region, Italy. Ital J Pediatr. 2025 Feb 7;51(1):34. doi: 10.1186/s13052-025-01871-6.
PubMed 39920754Assathiany R, Sznajder M, Cahn-Sellem F, Dolard C, Werner A. Effects of infant bronchiolitis on family life. Front Pediatr. 2024 Jun 19;12:1343045. doi: 10.3389/fped.2024.1343045. eCollection 2024.
PubMed 38962572Roque-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 37010196Gomes GR, Calvete FP, Rosito GF, Donadio MV. Rhinopharyngeal Retrograde Clearance Induces Less Respiratory Effort and Fewer Adverse Effects in Comparison With Nasopharyngeal Aspiration in Infants With Acute Viral Bronchiolitis. Respir Care. 2016 Dec;61(12):1613-1619. doi: 10.4187/respcare.04685. Epub 2016 Aug 23.
PubMed 27555618Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.
PubMed 20927359
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Outpatient Respiratory Physiotherapy on Hospitalizations and Costs in Infants With Acute Viral Bronchiolitis: A Quasi-Experimental Study in Public Health Services in Sorocaba.
- ClinicalTrials.gov ID
- NCT07682844
- Acronym / sponsor ID
- BVA-RESP / BVA_FISIO_SOROCABA_2026
- Conditions
- Acute Viral Bronchiolitis
- Keywords
- Child, Bronchiolitis, SUS, Hospitalization, Respiratory Therapy, Ambulatory Care, Public Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 8 Aug 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Jul 2026 (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 (AVB) is one of the leading causes of respiratory illness and hospitalization among infants during the first year of life, generating a substantial burden on healthcare services and public health expenditures. Despite the widespread use of respiratory physiotherapy in clinical practice, there is limited evidence regarding its effectiveness in preventing hospital admissions when provided in an outpatient setting.
This quasi-experimental study aims to evaluate the impact of an outpatient respiratory physiotherapy protocol on hospitalization rates among infants up to 12 months of age diagnosed with mild to moderate acute viral bronchiolitis in the public healthcare system of Sorocaba, Brazil. Infants referred for respiratory physiotherapy will be compared with a similar group of infants who receive standard medical care without physiotherapy referral.
The physiotherapy protocol includes slow expiratory techniques, rhinopharyngeal retrograde clearance, cough stimulation, and continuous positive airway pressure (CPAP) when clinically indicated. Participants will be followed through medical records and telephone monitoring.
The primary outcome is hospital admission due to bronchiolitis. Secondary outcomes include length of hospital stay, healthcare costs, and clinical evolution. The findings may provide evidence on whether outpatient respiratory physiotherapy can reduce hospitalizations and optimize healthcare resource utilization in infants with acute viral bronchiolitis.
Detailed description
Acute Viral Bronchiolitis (AVB) is the most common lower respiratory tract infection in infants and one of the leading causes of emergency department visits and hospital admissions during the first year of life. The disease imposes a substantial burden on healthcare systems, particularly during seasonal epidemics, resulting in increased healthcare utilization and costs.
Although respiratory physiotherapy is frequently used in clinical practice, its role in the management of bronchiolitis remains controversial. Most available studies have focused on hospitalized infants and have shown inconsistent results regarding clinically relevant outcomes. Furthermore, evidence regarding the effectiveness of respiratory physiotherapy in outpatient settings is scarce, and little is known about its potential impact on hospital admission rates and healthcare costs.
This study will be conducted in the public healthcare network of Sorocaba, São Paulo, Brazil, and is designed as a quasi-experimental study intended to emulate a clinical trial under real-world conditions. Infants up to 12 months of age diagnosed with mild or moderate acute viral bronchiolitis in participating emergency care units will be included. Participants referred for outpatient respiratory physiotherapy will constitute the intervention group, while infants with similar clinical characteristics who are not referred for physiotherapy will serve as the comparison group.
The respiratory physiotherapy protocol will include slow expiratory techniques, rhinopharyngeal retrograde clearance, cough stimulation, and continuous positive airway pressure (CPAP) when clinically indicated. Clinical assessment and treatment decisions will be based on standardized evaluation procedures and disease severity classification using the Wang Bronchiolitis Severity Score.
Data will be obtained from electronic medical records, physiotherapy records, and follow-up telephone contacts. The study aims to generate evidence regarding the effectiveness of outpatient respiratory physiotherapy in reducing healthcare utilization and improving the management of infants with acute viral bronchiolitis within a public healthcare system.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a quasi-experimental, parallel-group study designed to emulate a clinical trial under real-world healthcare conditions. Infants diagnosed with mild to moderate acute viral bronchiolitis will be allocated to study groups according to the clinical care pathway. The intervention group will consist of infants referred for outpatient respiratory physiotherapy, while the comparison group will include infants with similar clinical characteristics who are not referred for physiotherapy. Participants will be analyzed according to the intention-to-treat principle, based on referral status regardless of treatment adherence or completion.
| Arm | Type | Receives |
|---|---|---|
| Outpatient Respiratory Physiotherapy | Experimental | Procedure: Outpatient Respiratory PhysiotherapyInfants diagnosed with mild to moderate acute viral bronchiolitis who are referred for outpatient respiratory physiotherapy. The intervention may include slow expiratory techniques, rhinopharyngeal retrograde clearance, cough stimulation, and continuous positive airway pressure (CPAP) when clinically indicated, according to a standardized physiotherapy protocol. |
| Standard Care Group | No intervention | –Infants diagnosed with mild to moderate acute viral bronchiolitis who receive standard medical care through the municipal healthcare system. Outcome data will be obtained from routine clinical records. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants aged 12 months or younger.
- Clinical diagnosis of acute viral bronchiolitis.
- Mild or moderate bronchiolitis according to clinical assessment and Wang Bronchiolitis Severity Score.
- Initial evaluation performed at a participating emergency care unit (UPA).
- Parent or legal guardian able and willing to provide informed consent for participants receiving direct physiotherapy care.
Key exclusion criteria (4 listed)
- Severe bronchiolitis requiring immediate hospitalization or emergency medical intervention.
- Infants who did not follow the predefined clinical care pathway (e.g., no initial evaluation at a participating emergency care unit).
- Absence of a clinical diagnosis of acute viral bronchiolitis by the attending pediatrician.
- Any medical condition that, in the opinion of the clinical team, would make participation inappropriate or interfere with study procedures.
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 |
|---|---|---|
| Outpatient Respiratory PhysiotherapyAlso: Chest Physiotherapy, Respiratory Therapy, Airway Clearance TechniquesParticipants will receive an outpatient respiratory physiotherapy protocol for the management of mild to moderate acute viral bronchiolitis. The intervention may include Prolonged Slow Expiration, Slow Expiratory Flow Increase, Rhinopharyngeal Retrograde Clearance, cough stimulation, and continuous positive airway pressure (CPAP) when clinically indicated. Treatment will be individualized according to the infant's clinical condition, respiratory assessment findings, and bronchiolitis severity as determined by the Wang Bronchiolitis Severity Score. Sessions will be performed by trained physiotherapists and repeated as necessary based on clinical progression until discharge from physiotherapy follow-up. | Procedure or surgery | Outpatient Respiratory Physiotherapy |
Primary outcome
Hospitalization Prevention
Time frame: during the hospitalization period (up to 15 days)
Proportion of infants with acute viral bronchiolitis who do not require hospital admission after outpatient physiotherapy management.
1 secondary outcome
costs from the Brazilian public healthcare system perspective
Time frame: during the period of hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Results publication: PubMed 29654399Ghazaly M, Nadel S. Characteristics of children admitted to intensive care with acute bronchiolitis. Eur J Pediatr. 2018 Jun;177(6):913-920. doi: 10.1007/s00431-018-3138-6. Epub 2018 Apr 13.
- Results publication: PubMed 39920754Ballardini E, Manfrini M, Fattori S, Pellacani E, Cosic B, Gargano G, Berardi A. Hospitalizations for bronchiolitis among infants before and after the SARS-CoV-2 pandemic: an area-based study of the Emilia-Romagna Region, Italy. Ital J Pediatr. 2025 Feb 7;51(1):34. doi: 10.1186/s13052-025-01871-6.
- Results publication: PubMed 38962572Assathiany R, Sznajder M, Cahn-Sellem F, Dolard C, Werner A. Effects of infant bronchiolitis on family life. Front Pediatr. 2024 Jun 19;12:1343045. doi: 10.3389/fped.2024.1343045. eCollection 2024.
- Results publication: 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.
- Results publication: PubMed 27555618Gomes GR, Calvete FP, Rosito GF, Donadio MV. Rhinopharyngeal Retrograde Clearance Induces Less Respiratory Effort and Fewer Adverse Effects in Comparison With Nasopharyngeal Aspiration in Infants With Acute Viral Bronchiolitis. Respir Care. 2016 Dec;61(12):1613-1619. doi: 10.4187/respcare.04685. Epub 2016 Aug 23.
- Results publication: PubMed 20927359Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.
- Brazilian Ministry of Health database used to obtain information on hospital admissions and healthcare utilization related to acute viral bronchiolitis within the Brazilian Unified Health System (SUS).Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves identifiable health information from infants obtained through medical records and follow-up contacts. Although the data will be anonymized for analysis, no data-sharing plan has been established, in accordance with institutional policies and ethical requirements to protect participant confidentiality.
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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.
Fredi Alexander D Quijano, PhD study chair
School of Public Health, University of São Paulo (USP), São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient Respiratory Physiotherapy in people with Acute Viral Bronchiolitis, run by University of Sao Paulo at 1 site in Brazil.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franciny N Novaes, Graduate (+5515997576696, francinydantas@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization Prevention (time frame: during the hospitalization period (up to 15 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 NCT07682844, which also lists 6 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 16 Sep 2026.