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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Supportive Care
Allocation to intervention
N/A
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
Determine the usability of an interface and its accessories to provide non-invasive
respiratory therapy to neonates and infants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05719298
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05719298