Chest Physiotherapy in Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chest physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring bronchiolitis, chest physiotherapy, children
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
The participants just received standard medical treatment
The participants received medical treatment and chest physiotherapy sessions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04260919
First Posted
February 6, 2020
Last Updated
February 6, 2020
Sponsor
Universidade do Porto
1. Study Identification
Unique Protocol Identification Number
NCT04260919
Brief Title
Chest Physiotherapy in Bronchiolitis
Official Title
Chest Physiotherapy in Light and Moderate Bronchiolitis in Ambulatory Children Under Two Years of Age - a Randomised Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Porto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized trial of chest physiotherapy in outpatients with bronchiolitis under two years of age, during two consecutive seasonal outbreaks.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
bronchiolitis, chest physiotherapy, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial with two groups.
Masking
None (Open Label)
Masking Description
One control group and one intervention group, where chest physiotherapy is used.
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The participants just received standard medical treatment
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The participants received medical treatment and chest physiotherapy sessions
Intervention Type
Procedure
Intervention Name(s)
Chest physiotherapy
Primary Outcome Measure Information:
Title
Reduction of Kristjansson Respiratory Score
Description
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.
Time Frame
Baseline; after two weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Days
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34177198
Citation
Pinto FR, Alexandrino AS, Correia-Costa L, Azevedo I. Ambulatory chest physiotherapy in mild-to-moderate acute bronchiolitis in children under two years of age - A randomized control trial. Hong Kong Physiother J. 2021 Dec;41(2):99-108. doi: 10.1142/S1013702521500098. Epub 2021 Mar 31.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3433974/
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/23287014
Description
Related Info
Learn more about this trial
Chest Physiotherapy in Bronchiolitis
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