ANZCTR - Registration

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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

Treatment: Other

Comparator / control treatment

Own control - supine position

Control group

Active

Outcomes

Primary outcome [1]

Ventilation distribution measured by electrical impedance tomography (EIT)

Timepoint [1]

Measurements will be taken at 30 minutes, 2 hours and 4 hours after a position change.

Primary outcome [2]

Functional residual capacity (FRC)

Timepoint [2]

Measurements will be taken at 30 minutes, 2 hours and 4 hours after a position change.

Primary outcome [3]

Lung clearance index (LCI) as measured by multiple breath gas washout

Timepoint [3]

Measurements will be taken at 30 minutes, 2 hours and 4 hours after a position change.

Secondary outcome [1]

Oxygenation

Timepoint [1]

0.5, 2 and 4 hours

Secondary outcome [2]

Heart rate

Timepoint [2]

0.5, 2, and 4 hours

Secondary outcome [3]

Respiratory

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

JP Kelly Research Fund

Address [1]

Mater Health Services
Raymond Terrace
South Brisbane
QLD 4101

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Mater Health Services

Address [2]

Raymond Terrace
South Brisbane
QLD 4101

Country [2]

Australia

Primary sponsor type

Government body

Name

Mater Health Services

Address

Raymond Terrace
South Brisbane
QLD 4101

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Queensland

Address [1]

University of Queensland
St Lucia
QLD 4072

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Health Services

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/09/2004

Ethics approval number [1]

753M

Ethics committee name [2]

University of Queensland

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

11/11/2004

Ethics approval number [2]

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

Dr Judith Hough

Address

Physiotherapy Department
Mater Health Services
Raymond Terrace
South Brisbane
QLD 4101

Country

Australia

Phone

61 422404369

Fax

judyhough@optusnet.com.au

Contact person for public queries

Name

Judy Hough

Address

Department of Physiotherapy
Mater Health Services
South Brisbane QLD 4101

Country

Australia

Phone

+61 7 38408538

Fax

judyhough@optusnet.com.au

Contact person for scientific queries

Name

Judy Hough

Address

Department of Physiotherapy
Mater Health Services
South Brisbane QLD 4101

Country

Australia

Phone

+61 7 38408538

Fax

judyhough@optusnet.com.au

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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Documents added automatically

No additional documents have been identified.

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