Respiratory Physiotherapy and Hospitalization in Infants With Bronchiolitis (BVA-RESP)

June 30, 2026 updated by: Franciny Nunes Dantas Novaes, University of Sao Paulo

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01246-904
        • School of Public Health, University of São Paulo (USP), São Paulo, Brazil
        • Contact:
          • Fredi Alexander D Quijano, PhD
          • Phone Number: +55 11 946590193
          • Email: frediazq@usp.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Outpatient Respiratory Physiotherapy
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.
Procedure: Outpatient Respiratory Physiotherapy
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.
Other Names:
  • Chest Physiotherapy
  • Respiratory Therapy
  • Airway Clearance Techniques
No Intervention: Standard Care Group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the hospitalization period (up to 15 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
costs from the Brazilian public healthcare system perspective
Time Frame: during the period of hospitalization
Direct costs related to hospital admissions among infants with acute viral bronchiolitis, including hospitalization expenses and healthcare resource utilization.
during the period of hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Chair: Fredi Alexander D Quijano, PhD, School of Public Health, University of São Paulo (USP), São Paulo, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVA_FISIO_SOROCABA_2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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