Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000211561
Ethics application status
Approved
Date submitted
23/05/2006
Date registered
30/05/2006
Date last updated
6/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of active chest physiotherapy techniques on regional ventilation on preterm infants on ventilatory support.
Scientific title
The effect of active chest physiotherapy techniques on regional ventilation on preterm infants on ventilatory support.
Secondary ID [1] 287820 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm infants with respiratory disease on ventilatory support 1189 0
Condition category
Condition code
Respiratory 1272 1272 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 1273 1273 0 0
Complications of newborn
Physical Medicine / Rehabilitation 1274 1274 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active chest physiotherapy techniques of cupping and vibrations will be compared with each other in a random order. The techniques will be performed for 1 minute and then the infants will be postioned and left to rest for 4 hours before the other intervention is performed.
Intervention code [1] 1067 0
Treatment: Other
Comparator / control treatment
Own control
Control group
Active

Outcomes
Primary outcome [1] 1720 0
Ventilation distribution
Timepoint [1] 1720 0
At 0.5, 2 and 4 hours
Primary outcome [2] 296546 0
Ventilation distribution
Timepoint [2] 296546 0
30min, 2hr, 4hr
Secondary outcome [1] 3070 0
Oxygenation:
Timepoint [1] 3070 0
15 second intervals throughout 8 hour study.
Secondary outcome [2] 3072 0
Heart rate
Timepoint [2] 3072 0
15 second intervals throughout 8 hour study
Secondary outcome [3] 3073 0
Respiratory rate
Timepoint [3] 3073 0
15 second intervals throughout 8 hour study
Secondary outcome [4] 3074 0
Inccidence of cranial pathology eg. intraventricular haemorrhage (IVH), periventricular leucomalacia (PVL): routine ulstrasound scans.
Timepoint [4] 3074 0
At 5 days, 21-28 days.

Eligibility
Key inclusion criteria
Neonates who:are heavier than 750 gramsare less than or equal to 34 weeks gestationare >24 hours of age demonstrate clinical and/or radiological indications for active chest physiotherapy intervention such as increased secretions, increased ventilatory parameters, focal changes on chest x-ray.
Minimum age
Not stated
Maximum age
35 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiopulmonary instability not allowing position changesPost surgical eg. Tracheoesophageal fistula, diaphragmatic hernia, gastroschisis, Spina BifidaKnown air leak syndrome (Pneumothorax, pulmonary interstitial emphysema)Poor skin integrityMothers under 18 years of age.

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)
Sequentially numbered sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2006
Actual
5/10/2006
Date of last participant enrolment
Anticipated
Actual
8/06/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4584 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 12189 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 1394 0
Commercial sector/Industry
Name [1] 1394 0
Australian Physiotherapy Association Qld Branch Dorothy Hopkins Award
Country [1] 1394 0
Australia
Primary sponsor type
Government body
Name
Mater Health Services
Address
Raymond Terrace
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 1226 0
University
Name [1] 1226 0
University of Queensland
Address [1] 1226 0
University of Queensland
St Lucia
Qld 4067
Country [1] 1226 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293808 0
Mater Health Services
Ethics committee address [1] 293808 0
Raymond Terrace
South Brisbane
Qld 4101
Ethics committee country [1] 293808 0
Australia
Date submitted for ethics approval [1] 293808 0
01/12/2005
Approval date [1] 293808 0
01/06/2006
Ethics approval number [1] 293808 0
939M
Ethics committee name [2] 293809 0
University of Qld
Ethics committee address [2] 293809 0
University of Qld
St Lucia
Qld 4067
Ethics committee country [2] 293809 0
Australia
Date submitted for ethics approval [2] 293809 0
31/07/2007
Approval date [2] 293809 0
31/08/2007
Ethics approval number [2] 293809 0
2006000366

Summary
Brief summary
Chest physiotherapy (CPT) is a standard component of multidisciplinary care of preterm infants receiving artificial ventilation for respiratory failure. Despite this, there is limited evidence concerning its effectiveness. This study aims to quantify the effects of the physiotherapy techniques of percussion and vibration on respiratory function in the preterm infant.
Data from the electrical impedance tomography (EIT) and the multiple breath washout (MBW) will be downloaded directly onto a computer. The data analyst will be blinded as to the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36140 0
Dr Judith Hough
Address 36140 0
School of Physiotherapy
Australian Catholic University
1100 Nudgee Rd
Banyo
Qld 4014
Country 36140 0
Australia
Phone 36140 0
+61 0422404399
Fax 36140 0
Email 36140 0
[email protected]
Contact person for public queries
Name 10256 0
Dr Judy Hough
Address 10256 0
Department of Physiotherapy
Mater Health Services
South Brisbane QLD 4101
Country 10256 0
Australia
Phone 10256 0
+61 7 38408538
Fax 10256 0
Email 10256 0
[email protected]
Contact person for scientific queries
Name 1184 0
Dr Judy Hough
Address 1184 0
Department of Physiotherapy
Mater Health Services
South Brisbane QLD 4101
Country 1184 0
Australia
Phone 1184 0
+61 7 38408538
Fax 1184 0
Email 1184 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.