Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07682844

Respiratory Physiotherapy and Hospitalization in Infants With Bronchiolitis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Public Health, University of São Paulo (USP), São Paulo, Brazil

São Paulo, 01246-904, Brazil

Location contact

Fredi Alexander D Quijano, PhD

CONTACT

[email protected]

+55 11 946590193

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Outpatient Respiratory Physiotherapy

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Franciny N Novaes, Graduate

CONTACT

[email protected]

+5515997576696

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study 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.

Acronym: BVA-RESP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.