Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05719298




Registration number
NCT05719298
Ethics application status
Date submitted
31/01/2023
Date registered
8/02/2023
Date last updated
8/02/2023

Titles & IDs
Public title
Infant Respiratory Interface and Accessories Evaluation Study
Scientific title
Infant Respiratory Interface and Accessories Evaluation Study
Secondary ID [1] 0 0
CIA-235
Secondary ID [2] 0 0
UT-1111-1267-0940
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Distress Syndrome, Newborn 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Respiratory interface

Experimental: Respiratory interface - Use of the new respiratory interface and accessories to deliver non-invasive therapy


Treatment: Devices: Respiratory interface
Application of the new interface and accessories and provision of non-invasive respiratory support through the device.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feedback score
Timepoint [1] 0 0
12 hours

Eligibility
Key inclusion criteria
* Spontaneously breathing infants who require non-invasive respiratory support
* Parent(s)/guardian(s) at least 18 years of age
Minimum age
No limit
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Parent(s)/guardian(s) unable to give written informed consent
* Neonate or infant not requiring non-invasive support
* Suspected or confirmed abnormalities or trauma to the skull or airway

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Mater Mothers' Hospital NICU - Brisbane
Recruitment postcode(s) [1] 0 0
4101 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michelle Muir
Address 0 0
Country 0 0
Phone 0 0
095740100
Fax 0 0
Email 0 0
michelle.muir@fphcare.co.nz
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05719298