Impact of Respiratory Physiotherapy in Children With Bronchiolitis in the First Two Years of Life
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02708147|
Recruitment Status : Not yet recruiting
First Posted : March 15, 2016
Last Update Posted : July 5, 2017
This study aims to evaluate the recovery of children with bronchiolitis with and without physical therapy treatments.
The experimental group will receive educational information and 5 sessions of physiotherapy with the same protocol, at home or in physical therapy office. The control group will only be evaluated.
For both the experimental and control groups the lung sounds are recorded and the Wang's respiratory severity scale calculated initially and on the 3th, 5th and 21st days and computorized. After 3 months of the initial contact, there will be an interview by the phone about relapses or other clinical signs of bronchiolitis until then.
It is expected that the children receiving physiotherapy have a better recovery than the control group.
|Condition or disease||Intervention/treatment|
|Bronchiolitis||Other: Physiotheraphy + Conventional treatment Other: Conventional treatment|
Due to different opinions in the literature about the relevance of respiratory physiotherapy in the treatment of bronchiolitis, there is an urgent need to conduct studies with robust methodologies to explore the impact of physical therapy in children with bronchiolitis, especially on non-hospitalized, and to consider the different levels of severity of bronchiolitis.
This study aims to evaluate the recovery of children with bronchiolitis with and without physical therapy treatments primarily through the computerized respiratory sounds. As secondary goals secondary measures will be registered to evaluate and compare treatments, such as the duration and frequency of bronchiolitis until 3 months after the diagnosis.
The plan is to recruit approximately 52 children (until the age of 2) with 1st or 2nd bronchiolitis diagnostic by a pediatrician.
Then, the researcher will contact the legal representative of the participants to provide more detailed information and obtain the consent forms. Patients will then be randomly assigned to the conventional treatment group or the conventional treatment plus respiratory physiotherapy group.
The experimental group will receive 5 physiotherapy sessions at home or in a physical therapy office. The respiratory techniques follow a flowchart wich begins with saline instillation in the nose and nasopharyngeal cleaning techniques. Then to clear the lung slow inspiratory and slow and forced expiratory techniques will be used. The application of vibration is also included on the flowchart. During the sessions, educational information will also be provided.
The baseline evaluation will include sociodemographic, anthropometric and clinical data, the calculation of Wang's score and well as computerized lung auscultation. The lung sounds are recorded on 7 anatomic regions: trachea (sternum node) left and right anterior regions (middle clavicular line over the 2nd intercostal space), left and right lateral regions (axillary line over the 4th / 5th intercostal space), left and right back regions (5 cm from the para-vertebral line and 7 cm under the inferior angle of scapular) for approximately 20 seconds.
With the exception of the sample characterization data to be retrieved only in the first evaluation, all other measures will take place in the remaining three evaluations (3th, 5th and 21st days).
The experimental group will still have a final evaluation (auscultation, vital signs and Wang scale) at the end of each treatment session.
A follow-up evaluation will take place after 3 months with a phone interview regarding questioning the recurrence of bronchiolitis, as well as the current presence of symptoms such as cough, sore throat, nasal obstruction, respiratory noise, difficulty sleeping or feeding At the end of this study are expected better results on the experimental group, based on a robust methodology on the impact of respiratory therapy in children from 0 to 2 years, on the treatment bronchiolitis in order to justify the intervention of physiotherapy in this area and to generate recommendations for clinical practice.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Respiratory Physiotherapy in Children With Bronchiolitis in the First Two Years of Life|
|Anticipated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Sham Comparator: Conventional treatment
Conventional treatment means that there will be only contact with physician/paediatrician and maybe drugs prescription.
Only evaluations will be made at baseline and on the 3th, 5th and 21st days and an interview 30 days after.
Other: Conventional treatment
Medication and observation by a physician/paediatrician. Only evaluations will be made at baseline and on the 3th, 5th and 21st days and an interview 30 days after.
Other Name: Control
Experimental: Physiotheraphy + Conventional treatment
Apart Conventional treatment a Physiotherapy protocol (techniques and education) will be performed on 5 sessions and evaluations will be made after each session as well as on baseline and on the 3th, 5th and 21st days and an interview 30 days after.
Other: Physiotheraphy + Conventional treatment
The experimental group will receive 5 physiotherapy sessions at home or in a physical therapy office. The respiratory techniques follow a flowchart which begins with saline instillation into the nose and nasopharyngeal cleaning techniques. Then to clear the lung slow inspiratory and slow and forced expiratory techniques will be used. The application of vibration is also included on the flowchart. During the sessions, educational information will also be provided.
Other Name: Experimental
- Computerized lung sounds [ Time Frame: From the 1st to the 21st day. ]Adventitious lung sounds are sounds superimposed on the normal respiratory sound. There are continuous (wheezes) and discontinuous (crackles) adventitious sounds. They will indicate the severity and recovery of lung disease
- Wang severity scale [ Time Frame: From the 1st to the 21st day. ]Classification of severity of respiratory condition by Wang scale through the respiratory rate, presence of wheezing, retractions and overview.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708147
|Contact: Alda S Marques, PhD||+351234 372 firstname.lastname@example.org|
|Contact: Veronica L Abreu, MsH||+351 email@example.com|
|Principal Investigator:||Alda M Marques, PhD||Aveiro University|