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
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
Address
246 Clayton Road
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 287160 0
None
Name [1] 287160 0
Address [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
Monash Medical Centre
246 Clayton Road
Clayton
VIC 3168
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
Premature infants often need to receive additional oxygen treatment. Usually this is because they have a lung condition called chronic lung disease. To ensure that the right amount of oxygen is given to them, we routinely use a sensor (or probe) that tells us the oxygen level in the baby’s blood. This is the oxygen meter (pulse oximeter); that is a devices that measures the level of oxygen in the body. This sensor does not cause any harm or discomfort to the baby. Our team of doctors and nurses use a test that we call “overnight oximetry study” or simply “ a download”. The test involves using the measurements from the oxygen meter to tell them if the baby still needs oxygen treatment. There are some standard settings (in detail, the “averaging time” of the pulse oximeter) that most hospital put on their oxygen meters. To date, there has been no study to tell us which “averaging time” is best suited for this purpose. The aim of our study is investigate which averaging time(s) is(/are) most effective for the “overnight oximetry study” in premature babies when doctors use them to check when the babies are ready to stop oxygen treatment.
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 45107 0
Dr 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
[email protected]
Contact person for scientific queries
Name 45108 0
Dr 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
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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