Infant Respiratory Interface and Accessories Evaluation Study
Not Applicable
Not yet recruiting
- Conditions
- Respiratory Distress Syndrome, Newborn
- Interventions
- Device: Respiratory interface
- 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
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
- Arm && Interventions
Group Intervention Description Respiratory interface Respiratory interface Use of the new respiratory interface and accessories to deliver non-invasive therapy
- Primary Outcome Measures
Name Time Method Feedback score 12 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mater Mothers' Hospital NICU
🇦🇺Brisbane, Queensland, Australia