Infant Respiratory Interface and Accessories Evaluation Study

Not Applicable

Not yet recruiting

• Conditions: Respiratory Distress Syndrome, Newborn

• Registration Number: NCT05719298
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Last Update Submitted: 2023-01-31
• Study Start: 2023-02
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feedback score	12 hours

Trial Locations

Locations (1)

Mater Mothers' Hospital NICU; 🇦🇺 Brisbane, Queensland, Australia