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NCT05719298 Clinical Trial

Infant Respiratory Interface and Accessories Evaluation Study

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:
Infant Respiratory Interface and Accessories Evaluation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05719298
Other study ID # UT-1111-1267-0940
Secondary ID CIA-235
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2023
Est. completion date January 2026

Study information
Verified date January 2023
Source Fisher and Paykel Healthcare
Contact Michelle Muir
Phone 095740100
Email michelle.muir@fphcare.co.nz
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Australia Mater Mothers' Hospital NICU Brisbane Queensland

Sponsors (1)
Lead Sponsor Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feedback score 12 hours
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