Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000736448
Ethics application status
Approved
Date submitted
28/01/2025
Date registered
11/07/2025
Date last updated
11/07/2025
Date data sharing statement initially provided
11/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Neonatal unit patient responses to oxygen therapy
Scientific title
Peripheral oxygen saturation responses to changes in the fraction of inspired oxygen in neonatal unit patients on non-invasive respiratory support therapies
Secondary ID [1] 313216 0
Nil known
Universal Trial Number (UTN)
U1111-1315-9089
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal care 335515 0
Hypoxemia 336878 0
Condition category
Condition code
Reproductive Health and Childbirth 332075 332075 0 0
Complications of newborn
Respiratory 333076 333076 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
This observational study is to gather physiological information from infants who are prescribed oxygen therapy during non-invasive respiratory support.
Participants will receive the standard care before, during, and after completion of this trial

There is no direct patient's involvement. The data will be collected from the patients' observational chart, medical history, and Phillips IntelleVue monitoring system (that continuously tracks a patient’s vital signs and ventilator parameters).

The following parameters will be recorded from the observational chart: vital signs, blood gases, ventilation modes and parameters, incubator parameters.

The duration of the observation period - is up to 24 hours.
Intervention code [1] 329789 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339671 0
The primary outcome is oxygen saturation (SpO2) response to changes in FiO2 in neonates during non-invasive respiratory support with oxygen therapy.
Timepoint [1] 339671 0
Data will be continuously collected from the Philips IntelliVue system to the study laptop for up to 24 hours. Observational chart data will be updated every 60 minutes to 6 hours, depending on the parameters, hospital protocol, and treatment correction requirements.
Secondary outcome [1] 440822 0
There are no secondary endpoints.
Timepoint [1] 440822 0
There are no secondary endpoints.

Eligibility
Key inclusion criteria
1. Patients who require supplemental oxygen therapy
2. Provision of signed and dated informed consent from the parent/legal guardian
3. Availability for the duration of the study (up to 6 hours of oxygen therapy predicted within a 24-hour observation period)
Minimum age
0 Days
Maximum age
3 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are intubated
2. Involvement in another investigational study at the same time that may affect the results of this study

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
1/08/2026
Actual
Date of last data collection
Anticipated
2/08/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 26747 0
New Zealand
State/province [1] 26747 0
Canterbury

Funding & Sponsors
Funding source category [1] 317660 0
Commercial sector/Industry
Name [1] 317660 0
Fisher & Paykel Healthcare LTD
Country [1] 317660 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare LTD
Address
Country
New Zealand
Secondary sponsor category [1] 319973 0
None
Name [1] 319973 0
Address [1] 319973 0
Country [1] 319973 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316358 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316358 0
Ethics committee country [1] 316358 0
New Zealand
Date submitted for ethics approval [1] 316358 0
23/01/2025
Approval date [1] 316358 0
09/06/2025
Ethics approval number [1] 316358 0
2025 FULL 22556

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137638 0
Dr Daniel Mackay
Address 137638 0
Christchurch Hospital 2 Riccarton Avenue Christchurch 8011
Country 137638 0
New Zealand
Phone 137638 0
+64 03 364 4008
Fax 137638 0
Email 137638 0
[email protected]
Contact person for public queries
Name 137639 0
Elena Adaikina
Address 137639 0
Fisher and Paykel Healthcare, 15 Maurice Paykel Place East Tamaki, Auckland, 2013
Country 137639 0
New Zealand
Phone 137639 0
+64 9 574 0100
Fax 137639 0
Email 137639 0
[email protected]
Contact person for scientific queries
Name 137640 0
Elena Adaikina
Address 137640 0
Fisher and Paykel Healthcare, 15 Maurice Paykel Place East Tamaki, Auckland, 2013
Country 137640 0
New Zealand
Phone 137640 0
+64 9 574 0100
Fax 137640 0
Email 137640 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.