NCT04260919

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

February 6, 2020

Last Update Submit

March 20, 2024

Conditions

Keywords

bronchiolitischest physiotherapychildren

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control

NO INTERVENTION

The participants just received standard medical treatment

Intervention

EXPERIMENTAL

The participants received medical treatment and chest physiotherapy sessions

Procedure: Chest physiotherapy

Interventions

Intervention

Eligibility Criteria

Age15 Days - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
One control group and one intervention group, where chest physiotherapy is used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized trial with two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 7, 2020

Study Start

December 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2012

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share