Respiratory Physiotherapy and Hospitalization in Infants With Bronchiolitis
ConditionAcute Viral Bronchiolitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorUniversity of Sao Paulo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Outpatient Respiratory Physiotherapy
Procedure/SurgeryParticipants 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.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Outpatient Respiratory PhysiotherapyExperimental treatment 1 intervention
Group B: Standard Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Hospitalization Prevention
Proportion of infants with acute viral bronchiolitis who do not require hospital admission after outpatient physiotherapy management.
Time frame
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.
Time frame
during the period of hospitalizationSponsors and contacts
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Source ClinicalTrials.gov