Chest Physiotherapy in Bronchiolitis

NCT ID: NCT04260919

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized trial with two groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

One control group and one intervention group, where chest physiotherapy is used.

Study Groups

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Control

The participants just received standard medical treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

The participants received medical treatment and chest physiotherapy sessions

Group Type EXPERIMENTAL

Chest physiotherapy

Intervention Type PROCEDURE

Interventions

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Chest physiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Days

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Frederico Ramos Pinto

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 37010196 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34177198 (View on PubMed)

Related Links

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Other Identifiers

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FRP-01

Identifier Type: -

Identifier Source: org_study_id

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