Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000210572
Ethics application status
Approved
Date submitted
23/05/2006
Date registered
30/05/2006
Date last updated
20/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determination of differential effects of 3 positions on lung function in preterm infants.
Scientific title
Positioning to improve lung function in preterm infants requiring ventilatory support.
Secondary ID [1] 287704 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm infants requiring ventilatory support 1188 0
Condition category
Condition code
Reproductive Health and Childbirth 1271 1271 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Positioning - prone, supine, 1/4 prone. The infants rotate through the three different positions in a random order. Prior to the commencement of the study baseline measures are taken in the prone positiion. At 4 hourly intervals the baby is moved into the next nursing position with the study continuing for a total of 12 hours.
Intervention code [1] 1066 0
Treatment: Other
Comparator / control treatment
Own control - supine position
Control group
Active

Outcomes
Primary outcome [1] 1717 0
Ventilation distribution measured by electrical impedance tomography (EIT)
Timepoint [1] 1717 0
Measurements will be taken at 30 minutes, 2 hours and 4 hours after a position change.
Primary outcome [2] 1718 0
Functional residual capacity (FRC)
Timepoint [2] 1718 0
Measurements will be taken at 30 minutes, 2 hours and 4 hours after a position change.
Primary outcome [3] 1719 0
Lung clearance index (LCI) as measured by multiple breath gas washout
Timepoint [3] 1719 0
Measurements will be taken at 30 minutes, 2 hours and 4 hours after a position change.
Secondary outcome [1] 3067 0
Oxygenation
Timepoint [1] 3067 0
0.5, 2 and 4 hours
Secondary outcome [2] 3068 0
Heart rate
Timepoint [2] 3068 0
0.5, 2, and 4 hours
Secondary outcome [3] 3069 0
Respiratory
Timepoint [3] 3069 0
0.5, 2 and 4 hours

Eligibility
Key inclusion criteria
Neonates who:are heavier than 750 gramsare less than 32 weeks gestationare >24 hours of age have an arterial line in situ if mechanically ventilated.
Minimum age
0 Days
Maximum age
28 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiopulmonary instability not allowing position changesVentilated using high frequency oscillating ventilation (HFOV)Post surgical eg. Tracheoesophageal fistula, diaphragmatic hernia, gastroschisis, Spina BifidaKnown collapse/consolidation, or 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
1/05/2005
Actual
11/08/2005
Date of last participant enrolment
Anticipated
Actual
26/10/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1392 0
Charities/Societies/Foundations
Name [1] 1392 0
JP Kelly Research Fund
Country [1] 1392 0
Australia
Funding source category [2] 1393 0
Hospital
Name [2] 1393 0
Mater Health Services
Country [2] 1393 0
Australia
Primary sponsor type
Government body
Name
Mater Health Services
Address
Raymond Terrace
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 1225 0
University
Name [1] 1225 0
University of Queensland
Address [1] 1225 0
University of Queensland
St Lucia
QLD 4072
Country [1] 1225 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2745 0
Mater Health Services
Ethics committee address [1] 2745 0
Ethics committee country [1] 2745 0
Australia
Date submitted for ethics approval [1] 2745 0
Approval date [1] 2745 0
22/09/2004
Ethics approval number [1] 2745 0
753M
Ethics committee name [2] 2746 0
University of Queensland
Ethics committee address [2] 2746 0
Ethics committee country [2] 2746 0
Australia
Date submitted for ethics approval [2] 2746 0
Approval date [2] 2746 0
11/11/2004
Ethics approval number [2] 2746 0
2004000728

Summary
Brief summary
Preterm infants are moved throughout different positions while nursed in the neonatal nursery. The aim of this study is to determine the effects of 3 commonly used positions on lung function in those infants requiring ventilatory support. The positions to be used include prone (lying on the stomach), supine (lying on the back), and ¼ turn from prone (lying on stomach with one side up).
By looking at the ventilation distribution during positioning, this study will give clinicians an idea of how to optimise ventilation non-invasively using positioning. Factors we are investigating that are important in making this decision are optimal lung aeration and oxygenation.
This trial will use recently developed scientific technology including lung scanning (EIT) and a new form of breath washout (MBW using sulphur hexafluoride) to give us a better understanding of the effectiveness of positioning. Data on EIT and MBW will be downloaded directly onto a computer and the data analyst will be blinded to the positions.
Trial website
Trial related presentations / publications
Karly Montgomery, Nancy Low Choy, Michael Steele, Judith Hough. (2014) The effectiveness of quarter turn from prone in maintaining respiratory function in premature infants: a randomised cross-over trial. Journal of Paediatrics and Child Health. 50 (12): 972 – 977.doi:10.1111/jpc.12689

Hough JL, Johnston L, Brauer S, Woodgate P, Schibler A. (2013) Effect of body position on ventilation distribution in ventilated preterm infants. Pediatric and Critical Care Medicine 14(2): 171-177. DOI:10.1097/PCC.Ob013e31826e708a

Hough JL, Johnston L, Brauer S, Woodgate P, Pham T, Schibler A. (2012) Effect of body position on ventilation distribution in preterm infants on continuous positive airway pressure. Pediatric and Critical Care Medicine 2012; 13(4): 446-51 doi: 10.1097/PCC.0b013e31822f18d92011

Dunlop S, Hough J, Riedel T, Fraser JF, Dunster K, Schibler A. (2006) Electrical impedance tomography in extremely prematurely born infants and during high frequency oscillatory ventilation analyzed in the frequency domain. Physiol Meas. 27(11):1151-65. (IF: 1.412)

Montgomery K, Hough J, Low Choy N, Schibler A, Steele M. (2011) A comparative study of positioning on premature infants respiratory function. Oral presentation at the Australian Physiotherapy Conference, Brisbane

Hough JL, Shearman AD, Liley HG, Grant CA, Schibler A (2011) Lung derecruitment related to endotracheal suction in ventilated preterm infants. Oral presentation for the 6th World Congress on Pediatric Critical Care, Sydney, Australia

Hough J, Johnston L, Brauer S, Woodgate P, Schibler A. (2008) Effect of positioning on ventilation distribution in preterm infants. 18th ERS Annual Congress Proceedings. European Respiratory Journal 32(S52) A3013

Hough J, Johnston L, Brauer S, Woodgate P, Schibler A. (2007) Effect of positioning on ventilation distribution in preterm infants with and without lung disease. PSANZ 11th Annual Conference Proceedings J Paediatr Child Health 2007 43 (s1), A59

Hough JL, Johnston LM, Brauer SG, Woodgate PG & Schibler A (2005) Determination of the effects of prone, supine and quarter-prone positioning on lung function in preterm infants on CPAP. Paper presented at the Australian Physiotherapy Association National Cardiothoracic Association, Melbourne (Awarded Jill Nosworthy prize for excellence in research)
Public notes

Contacts
Principal investigator
Name 35334 0
Dr Judith Hough
Address 35334 0
Physiotherapy Department
Mater Health Services
Raymond Terrace
South Brisbane
QLD 4101
Country 35334 0
Australia
Phone 35334 0
61 422404369
Fax 35334 0
Email 35334 0
[email protected]
Contact person for public queries
Name 10255 0
Judy Hough
Address 10255 0
Department of Physiotherapy
Mater Health Services
South Brisbane QLD 4101
Country 10255 0
Australia
Phone 10255 0
+61 7 38408538
Fax 10255 0
Email 10255 0
[email protected]
Contact person for scientific queries
Name 1183 0
Judy Hough
Address 1183 0
Department of Physiotherapy
Mater Health Services
South Brisbane QLD 4101
Country 1183 0
Australia
Phone 1183 0
+61 7 38408538
Fax 1183 0
Email 1183 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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