Infant Respiratory Interface and Accessories Evaluation Study

Fisher & Paykel Healthcare

Status: Not yet enrolling

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Device: Respiratory interface

Study type: Interventional

Funder types: Industry

Identifiers

NCT05719298

UT-1111-1267-0940

CIA-235 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Respiratory interface

Experimental group

Description:

Use of the new respiratory interface and accessories to deliver non-invasive therapy

Treatment:

Device: Respiratory interface