Back to resultsInfant Respiratory Interface and Accessories Evaluation Study
Primary Purpose
Respiratory Distress Syndrome, Newborn
Status
Not yet recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Respiratory interface
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Distress Syndrome, Newborn
Eligibility Criteria
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
Sites / Locations
- Mater Mothers' Hospital NICU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Respiratory interface
Arm Description
Use of the new respiratory interface and accessories to deliver non-invasive therapy
Outcomes
Primary Outcome Measures
Feedback score
Secondary Outcome Measures
Full Information
NCT ID
NCT05719298
First Posted
January 31, 2023
Last Updated
January 31, 2023
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT05719298
Brief Title
Infant Respiratory Interface and Accessories Evaluation Study
Official Title
Infant Respiratory Interface and Accessories Evaluation Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Respiratory interface
Arm Type
Experimental
Arm Description
Use of the new respiratory interface and accessories to deliver non-invasive therapy
Intervention Type
Device
Intervention Name(s)
Respiratory interface
Intervention Description
Application of the new interface and accessories and provision of non-invasive respiratory support through the device.
Primary Outcome Measure Information:
Title
Feedback score
Time Frame
12 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Muir
Phone
095740100
Email
michelle.muir@fphcare.co.nz
Facility Information:
Facility Name
Mater Mothers' Hospital NICU
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Jardine
12. IPD Sharing Statement
Learn more about this trial
Infant Respiratory Interface and Accessories Evaluation Study
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