Infant Respiratory Interface and Accessories Evaluation Study
Sponsor
Fisher and Paykel Healthcare (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05719298
Collaborator
(none)
150
1
1
35
4.3
Study Details
Study Description
Brief Summary
Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Infant Respiratory Interface and Accessories Evaluation Study
Anticipated Study Start Date
:
Feb 1, 2023
Anticipated Primary Completion Date
:
Jan 1, 2026
Anticipated Study Completion Date
:
Jan 1, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Respiratory interface Use of the new respiratory interface and accessories to deliver non-invasive therapy |
Device: Respiratory interface
Application of the new interface and accessories and provision of non-invasive respiratory support through the device.
|
Outcome Measures
Primary Outcome Measures
- Feedback score [12 hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 2 Years
Sexes Eligible for Study:
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:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mater Mothers' Hospital NICU | Brisbane | Queensland | Australia | 4101 |
Sponsors and Collaborators
- Fisher and Paykel Healthcare
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT05719298
Other Study ID Numbers:
- UT-1111-1267-0940
- CIA-235
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: