Respiratory Physiotherapy and Hospitalization in Infants With Bronchiolitis

NCT07682844 | Not Yet Recruiting

• 1 other identifier: BVA_FISIO_SOROCABA_2026
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Viral Bronchiolitis

Keywords

Child; Bronchiolitis; SUS; Hospitalization; Respiratory Therapy; Ambulatory Care; Public Health

Outcome Measures

Primary Outcomes (1)

• Hospitalization Prevention

  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 Outcomes (1)

• costs from the Brazilian public healthcare system perspective

  during the period of hospitalization

Study Arms (2)

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.

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.

Interventions

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.

Also known as: Chest Physiotherapy, Respiratory Therapy, Airway Clearance Techniques

Outpatient Respiratory Physiotherapy

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

São Paulo, São Paulo, 01246-904, Brazil

Location

Related Publications (6)

• 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.

  PMID: 29654399 RESULT

• Ballardini 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.

  PMID: 39920754 RESULT

• Assathiany 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.

  PMID: 38962572 RESULT

• 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.

  PMID: 37010196 RESULT

• Gomes 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.

  PMID: 27555618 RESULT

• Gajdos 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.

  PMID: 20927359 RESULT

Related Links

• 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).

MeSH Terms

Conditions

Bronchiolitis

Interventions

Respiratory Therapy

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Fredi Alexander D Quijano, PhD

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

  STUDY CHAIR

Central Study Contacts

Franciny N Novaes, Graduate

CONTACT

+5515997576696; francinydantas@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label, non-randomized, quasi-experimental study. Participants, caregivers, healthcare providers, investigators, and outcome assessors are aware of the intervention status, as group assignment is determined by the routine clinical referral pathway for outpatient respiratory physiotherapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist and Master's Student in Public Health at the School of Public Health, University of São Paulo

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)