- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01017081
Chest Physiotherapy in Pediatrics Patients With Pneumonia
November 19, 2009 updated by: Santa Casa de Porto Alegre
Chest Physiotherapy in Pediatric Patients Hospitalised With Community-acquired Pneumonia: a Randomized Clinical Trial
Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia however there was no evidence to support a beneficial effect in pediatric patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio Grande do Sul
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Posto Alegre, Rio Grande do Sul, Brazil, 90020-160
- Santa Casa de Porto Alegre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours)
Exclusion Criteria:
- Severely ill patients (hospitalized in intensive care units)
- Pleural effusion treated with chest drainage
- Atelectasis detected by x-ray
- Pneumonia or pleural effusion in the previous six months
- Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Non-mandatory request to maintain lateral positioning to improve air exchange, to cough in order to clear secretion, and to perform diaphragmatic and deep breathing, for five minutes, once a day, during hospital stay.
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Non-mandatory request to maintain lateral positioning to improve air exchange and cough
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Experimental: Physiotherapy
Physiotherapy: Children younger than 5 years: Manual Thoracic vibration (TV), thoracic compression (TC), positive expiratory pressure (PEP), and forced exhalation with the glottis open ("huffing").
Children aged 5 years or older: same procedures in addition to the ventilatory patterns, and a forced expiratory technique (FET), consisting of one or two "huffs" (forced expirations) followed by a period of relaxed, controlled diaphragmatic breathing, three times per day, for 10 to 12 minutes, during hospital admission.
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Physiotherapy: three times per day, for 10 to 12 minutes, during hospital admission
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Primary Completion (Actual)
September 1, 2002
Study Completion (Actual)
September 1, 2002
Study Registration Dates
First Submitted
November 19, 2009
First Submitted That Met QC Criteria
November 19, 2009
First Posted (Estimate)
November 20, 2009
Study Record Updates
Last Update Posted (Estimate)
November 20, 2009
Last Update Submitted That Met QC Criteria
November 19, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FISIOPUL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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