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Not yet recruitingNCT05719298Updated Feb 8, 2023

Infant Respiratory Interface and Accessories Evaluation Study

An interventional study of Respiratory interface in Respiratory Distress Syndrome, Newborn, sponsored by Fisher and Paykel Healthcare. Not yet recruiting at 1 site in Australia. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
Up to 2 Years
Sex
All
01

Study summary

Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.

02

Conditions studied

  • Respiratory Distress Syndrome, Newborn
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Fisher and Paykel Healthcare is the lead sponsor of 84 studies on the registry; 15 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Spontaneously breathing infants who require non-invasive respiratory support
  • Parent(s)/guardian(s) at least 18 years of age

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Respiratory interface

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

    Device: Respiratory interface

Interventions

  • DeviceRespiratory interface

    Application of the new interface and accessories and provision of non-invasive respiratory support through the device.

06

What researchers measure

Primary outcomes

  1. Feedback score

    Time frame: 12 hours

07

Study locations

1 site
  • Mater Mothers' Hospital NICU
    Brisbane, Queensland 4101, Australia
    • Luke Jardine · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05719298
Lead sponsor
Fisher and Paykel Healthcare
Responsible party
Sponsor
First posted
Feb 8, 2023
Start date
Feb 2023 (estimated)
Primary completion
Jan 2026 (estimated)
Completion
Jan 2026 (estimated)
Last update
Feb 8, 2023

Study contacts

Michelle Muir
Contact
michelle.muir@fphcare.co.nz
095740100

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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