Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000564358
Ethics application status
Approved
Date submitted
19/09/2008
Date registered
10/11/2008
Date last updated
10/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Respiratory physiotherapy effect in very low birth weight newborn infants.
Scientific title
The effects of respiratory physiotherapy on the cardiopulmonary function in very low birth weight newborns infants.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
respiratory physiotherapy 3717 0
Condition category
Condition code
Respiratory 3888 3888 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
respiratory physiotherapy which includes positioning in right and left lateral decubitus,manual vibration and respiratory exercises; endotracheal suction is the suction of endotracheal tube that performed in open system. The infants received the respiratory physiotherapy for a maximum period of 10 minutes. The variables studied were measurement before and after this procedures. The endotracheal suction were carried out 5 minutes after the respiratory physiotherapy and the variables were verified immediately after and 5 minutes after the suction.
Intervention code [1] 3429 0
Other interventions
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4786 0
heart rate was carried out using the Vital Signs Monitoring System DX 2010 LCD Dixtal Biomedica that is pulse oximetry.
Timepoint [1] 4786 0
before and after respiratory physiotherapy and suction endotracheal
Primary outcome [2] 4787 0
oxygen saturation was carried out using the Vital Signs Monitoring System DX 2010 LCD Dixtal Biomedica that is pulse oximetry.
Timepoint [2] 4787 0
before and after respiratory physiotherapy and suction endotracheal
Secondary outcome [1] 8083 0
arterial system pressure was carried out using Vital Signs Monitoring System DX 2010 LCD Dixtal Biomedica that is oscilometric method.
Timepoint [1] 8083 0
after endotracheal suction

Eligibility
Key inclusion criteria
preterm newborns in mechanical ventilation
Minimum age
0 Days
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
abnormal malformations and genetic syndromes

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 1214 0
Brazil
State/province [1] 1214 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 3896 0
Hospital
Name [1] 3896 0
Hospital das Clinicas
Country [1] 3896 0
Brazil
Primary sponsor type
Individual
Name
Carla Marques Nicolau
Address
Rua Gabriel de Brito,332
Country
Brazil
Secondary sponsor category [1] 3498 0
Individual
Name [1] 3498 0
Mario Cicero Falcao
Address [1] 3498 0
Av Dr Eneas Carvalho de Aguiar,647
Country [1] 3498 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5949 0
Comissao de Pesquisa e Etica do Hospital das Clinicas -CApPesq
Ethics committee address [1] 5949 0
Ethics committee country [1] 5949 0
Brazil
Date submitted for ethics approval [1] 5949 0
01/07/2002
Approval date [1] 5949 0
10/12/2002
Ethics approval number [1] 5949 0
1078/02

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28952 0
Address 28952 0
Country 28952 0
Phone 28952 0
Fax 28952 0
Email 28952 0
Contact person for public queries
Name 12109 0
Carla Marques Nicolau
Address 12109 0
Av Dr Eneas Carvalho de Aguiar,255
Country 12109 0
Brazil
Phone 12109 0
30698558
Fax 12109 0
30696081
Email 12109 0
[email protected]
Contact person for scientific queries
Name 3037 0
Mario Cicero Falcao
Address 3037 0
Av Dr Eenas Carvalho de Aguira,255
Country 3037 0
Brazil
Phone 3037 0
30698500
Fax 3037 0
30698500
Email 3037 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.