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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during the period of hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Franciny N Novaes, Graduate | Contact | +5515997576696 | francinydantas@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Fredi Alexander D Quijano, PhD | School of Public Health, University of São Paulo (USP), São Paulo, Brazil | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Public Health, University of São Paulo (USP), São Paulo, Brazil | São Paulo | São Paulo | 01246-904 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29654399 | Result | 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. | |
| 39920754 | 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. |
| Label | URL |
|---|---|
| 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). | View source |
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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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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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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.
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| 38962572 | 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. |
| 37010196 | 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. |
| 27555618 | 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. |
| 20927359 | 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. |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |