Respiratory Distress Syndrome, NewbornNCT05719298
Infant Respiratory Interface and Accessories Evaluation Study
A study testing Respiratory interface in people with Respiratory Distress Syndrome, Newborn, run by Fisher and Paykel Healthcare at 1 site in Australia.
Trial summary
Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Respiratory interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spontaneously breathing infants who require non-invasive respiratory support
- Parent(s)/guardian(s) at least 18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Mater Mothers' Hospital NICU
Brisbane, Queensland, 4101
Luke Jardine
About this study
Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Respiratory interface
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory interfaceDevice
Application of the new interface and accessories and provision of non-invasive respiratory support through the device.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory interface | Experimental | Use of the new respiratory interface and accessories to deliver non-invasive therapy Receives: Device: Respiratory interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feedback score
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719298
- Sponsor's protocol ID
- UT-1111-1267-0940
- Other IDs
- CIA-235
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Respiratory Interface and Accessories Evaluation Study
- ClinicalTrials.gov ID
- NCT05719298
- Acronym / sponsor ID
- UT-1111-1267-0940
- Conditions
- Respiratory Distress Syndrome, Newborn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory interface | Experimental | Device: Respiratory interfaceUse of the new respiratory interface and accessories to deliver non-invasive therapy |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Spontaneously breathing infants who require non-invasive respiratory support
- Parent(s)/guardian(s) at least 18 years of age
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory interfaceApplication of the new interface and accessories and provision of non-invasive respiratory support through the device. | Device | Respiratory interface |
Primary outcome
Feedback score
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory interface in people with Respiratory Distress Syndrome, Newborn, run by Fisher and Paykel Healthcare at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Muir (095740100, michelle.muir@fphcare.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feedback score (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.