Chest Physiotherapy in Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Chest Physiotherapy in Light and Moderate Bronchiolitis in Ambulatory Children Under Two Years of Age - a Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260919
• Other study ID #: FRP-01
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2024
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized trial of chest physiotherapy in outpatients with bronchiolitis under two years of age, during two consecutive seasonal outbreaks.

Description:

A randomized controlled trial was conducted (following CONSORT Statement) in the Paediatric Emergency Department of Centro Hospitalar Universitário São João-Porto (CHUSJ), a tertiary care hospital, during the period from December to March in 2011 and 2012.

Ethical approval was obtained from the Ethics Committee of Centro Hospitalar Universitário São João-Porto.

Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis based on clinical findings, including wheezing or wheezing with crackles, respiratory distress and alteration of feeding condition, were signalized by the physician who met them at the emergency room.

Then, the main investigator of the study interviewed the caregivers and informed about the aims and procedures of the study, after a formal written consent in accordance with the Declaration of Helsinki was sign by all the caregivers.

Severity grade was established with the Kristjansson Respiratory Score which variate from light to severe, being the light to moderate selected to study.

Randomization in intervention or control group was made by the method of permuted-blocks. All children were assessed in a calm environment, while awake and not crying, and were submitted to a standard assessment protocol consisting of a clinical demographic data collection by interview of parents and the application of the Kristjansson Respiratory Score. All children underwent the same medical treatment protocol at the pediatric emergency department (PED), consisting in nebulization with medication, during the emergency room episode, and counselled in the subsequent one or two weeks and were followed during two weeks after discharge from PED, being reassessed at the end of the two weeks.

Children from Intervention Group (IG) underwent a standard intervention chest physiotherapy protocol performed by a physiotherapist, consisting on the techniques: prolonged slow expiration (PSE), rhinopharyngeal retrograde clearance (RRC) and provoked cough (PC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Days to 24 Months

Eligibility

Inclusion Criteria:

• Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis

Exclusion Criteria:

• presence of comorbidities, such as cystic fibrosis, neuromuscular, congenital heart disease, prematurity or respiratory distress and all the cases that were admitted into the hospital

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Procedure:
• Chest physiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Kristjansson Respiratory Score	Verified by changes in the Kristjansson Respiratory Score, which is a practical and simple score, that assesses the main signs and symptoms of bronchiolitis, having a good validity and inter-observer reliability.It assigns a value between 0 and 2 to each of the five variables: respiratory rate, chest recession, breath sound, skin colour and general condition. A higher Kristjansson respiratory score indicate a worse respiratory condition.	Baseline; after two weeks of treatment

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