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Trial registered on ANZCTR


Registration number
ACTRN12608000601336
Ethics application status
Approved
Date submitted
30/09/2008
Date registered
1/12/2008
Date last updated
1/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chest physiotherapy effectiveness in infants with acute bronchiolitis
Scientific title
Comparison of effectivness between anglo-saxon chest physiotherapy techniques and european chest physiotherapy techniques in infants diagnosed with acute bronchiolitis
Secondary ID [1] 730 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Bronchiolitis 3773 0
Condition category
Condition code
Respiratory 3947 3947 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anglo-saxon Chest Physiotherapy Techniques. Number of sessions: 14. Time period: 5 weeks. Duration per session: 30min. Anglo-saxon Chest Physioterapy techniques: inalotherapy, vibration, postural drainage, percussion and induced cough.
Intervention code [1] 3484 0
Treatment: Other
Intervention code [2] 3485 0
Rehabilitation
Intervention code [3] 3486 0
Other interventions
Comparator / control treatment
European Chest Physiotherapy Techniques.
Number of sessions: 8 Time period: 3 weeks. Duration per session: 30min.European Chest Physiotherapy techniques:inalotherapy, ELPr (French: expiration lente prolongee-passive slow expiration) induced cough.
Control group
Active

Outcomes
Primary outcome [1] 4844 0
Wangs Severity Clinical Score: evaluation of wheezing, respiratory rate, retractions, general condition.
Timepoint [1] 4844 0
Before physiotherapy session, immediately after physiotherapy session and ten minutes after physiotherapy session. This will be assessed after each physiotherapy session during the study period.
Secondary outcome [1] 8185 0
hospitalization period by assessing local hospital data
Timepoint [1] 8185 0
at hospital discharge
Secondary outcome [2] 8186 0
cardiovascular system integration: Pulse Oxymetry, Heart Rate.
Timepoint [2] 8186 0
Before physiotherapy session, immediately after physiotherapy session and ten minutes after physiotherapy session.This will be assessed after each physiotherapy session during the study period.

Eligibility
Key inclusion criteria
Age between 0 and 24 months, recent acute bronchiolitis diagnostic attested by a physician and a posteroanterior (PA) Thorax X-Ray incidence
Minimum age
0 Months
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants older than 24 months, patients diagnosed with respiratory, neurological or muscular associated disease.
Infants without physician support and without recent posteranterior (PA) thorax X-Ray.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by phone call order. Even calls, group one. Uneven calls, group two.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 1243 0
Brazil
State/province [1] 1243 0
Sao Paulo/Campinas

Funding & Sponsors
Funding source category [1] 4026 0
Self funded/Unfunded
Name [1] 4026 0
Country [1] 4026 0
Primary sponsor type
Individual
Name
Rafael Cofiño de Sá
Address
Rua Abolição, 1827, Swift, Campinas-SP
Country
Brazil
Secondary sponsor category [1] 3540 0
None
Name [1] 3540 0
None
Address [1] 3540 0
None
Country [1] 3540 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6012 0
Comite de Etica e pesquisa Hospital Municipal Dr. Mario Gatti CNS/MS 25000.061914/2005-91
Ethics committee address [1] 6012 0
Avenida Prefeito Faria Lima, 340 Pq. Italia, Campinas-SP
Ethics committee country [1] 6012 0
Brazil
Date submitted for ethics approval [1] 6012 0
Approval date [1] 6012 0
26/07/2008
Ethics approval number [1] 6012 0
016/08

Summary
Brief summary
Acute bronchiolitis is a disorder most commonly caused in infants by viral lower respiratory tract infection, predominantly due to respiratory syncytial virus. Considered the most frequent cause of hospitalization among infants during winter, its management is still controversial. Physiotherapy is usually recommended for these patients. The clinical impression of physicians and physiotherapists is that manual techniques may potentially reduce the intensity of the acute illness in infants, but the real effectiveness remains unclear and untested. Besides, there are two major groups of manual techniques that compose chest physiotherapy – anglo-saxon and european - but neither was systematically compared. The aim of this trial is to investigate if there is a group of techniques that improves the clinical outcomes of infants with acute bronchiolitis.
Trial website
Trial related presentations / publications
Poster presentation:
14o Simpósio Internacional de Fisioterapia Respiratória e Terapia Intensiva
10-12 September, 2008. Recife-PE, Brazil.
Public notes

Contacts
Principal investigator
Name 28990 0
Address 28990 0
Country 28990 0
Phone 28990 0
Fax 28990 0
Email 28990 0
Contact person for public queries
Name 12147 0
Rafael Cofiño de Sá
Address 12147 0
Rua Abolição, 1827, Swift, Campinas-SP
Country 12147 0
Brazil
Phone 12147 0
+55 19 32373878 +55 19 91118691
Fax 12147 0
Email 12147 0
[email protected]
Contact person for scientific queries
Name 3075 0
Alice Bella Lisbôa
Address 3075 0
Rua Abolição, 1827, Swift, Campinas-SP, Brazil
Country 3075 0
Brazil
Phone 3075 0
+55 19 32373878 +55 19 92475175
Fax 3075 0
55 19 32891429
Email 3075 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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