Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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
ACTRN12614000764639
Ethics application status
Approved
Date submitted
3/02/2014
Date registered
17/07/2014
Date last updated
17/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Overnight Pulse Oximetry in Preterm Infants - The Role of Oximetry Averaging Times
Scientific title
The effect of shorter versus longer oximeter averaging times on desaturation events in preterm infants in NICU undergoing overnight pulse oximetry.
Secondary ID [1] 283799 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic neonatal lung disease 290777 0
Prematurity 292474 0
Condition category
Condition code
Reproductive Health and Childbirth 291140 291140 0 0
Complications of newborn
Respiratory 292784 292784 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Pulse oximeter is widely used in the NICU as a way of assessing oxygenation in newborn infants. A sensor is attached to upper or lower limbs. The device utilises light in the red and near-infrared spectrum and the absorption of these two light pulses is dependant on the levels of oxygenated and deoxygenated hemoglobin in the tissue; the device algorithm subsquently converts these into a readout of arterial oxygenation. Pulse oximeter with 2 or 8 seconds averaging time will be utilised continuous over 1 night when the infant has an overnight oximetry performed.
Intervention code [1] 288483 0
Not applicable
Comparator / control treatment
A Masimo pulse oximeter is used for measuring oxygenation non-invasively. Clinical pulse oximeter with 8 seconds averaging time and a will be utilised continuously over 1 night as per standard NICU overnight oximetry protocol.
Control group
Active

Outcomes
Primary outcome [1] 291130 0
Desaturation events detected by analysis software (ProFoX)- defined as SpO2 levels < 90%
Timepoint [1] 291130 0
Completion of overnight pulse oximetry study
Primary outcome [2] 291131 0
Episodes of desaturation, defined as oxygen saturation less than the current target of 90%. Various levels of desaturations will also be delineated, namely <85%, <80% and less than 70%. This will be assessed utilising analysis software ProFox and also analysis utilising LabChart software.
Timepoint [2] 291131 0
Completion of the overnight pulse oximetry study, i.e. the desaturation episodes that occured during the study.
Primary outcome [3] 292472 0
Reports by the Respiratory Paediatrician of their interpretation of the PROFOX oximeter reports
Timepoint [3] 292472 0
After the completion of the study
Secondary outcome [1] 309392 0
Median SpO2 levels from data collected by ProFox and LabChart software.
Timepoint [1] 309392 0
Completion of the overnight pulse oximetry study.

Eligibility
Key inclusion criteria
All infants who are in the NICU at Monash Newborn born less than 32 weeks gestation who meet the ANZNN criteria for CNLD who require overnight pulse oximetry
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Where parental consent cannot be obtained

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1867 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 7651 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 288457 0
University
Name [1] 288457 0
Monash University
Country [1] 288457 0
Australia
Primary sponsor type
University
Name
Department of Paediatrics, Monash University
Country
Australia
Secondary sponsor category [1] 287160 0
None
Name [1] 287160 0
Country [1] 287160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290326 0
Human Research Ethics Committee B
Ethics committee address [1] 290326 0
Ethics committee country [1] 290326 0
Australia
Date submitted for ethics approval [1] 290326 0
Approval date [1] 290326 0
15/11/2013
Ethics approval number [1] 290326 0
13361B

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 45106 0
Dr Kenneth Tan
Address 45106 0
Monash Newborn Monash Medical Centre 246 Clayton Road Clayton VIC 3168
Country 45106 0
Australia
Phone 45106 0
+61-3-95945191
Fax 45106 0
Email 45106 0
kenneth.tan@monash.edu
Contact person for public queries
Name 45107 0
Kenneth Tan
Address 45107 0
Monash Newborn Monash Medical Centre 246 Clayton Road Clayton VIC 3168
Country 45107 0
Australia
Phone 45107 0
+61-3-95945191
Fax 45107 0
Email 45107 0
kenneth.tan@monash.edu
Contact person for scientific queries
Name 45108 0
Kenneth Tan
Address 45108 0
Monash Newborn Monash Medical Centre 246 Clayton Road Clayton VIC 3168
Country 45108 0
Australia
Phone 45108 0
+61-3-95945191
Fax 45108 0
Email 45108 0
kenneth.tan@monash.edu

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.