Infant Respiratory Interface and Accessories Evaluation Study

N/AUnknownNCT05719298

Fisher and Paykel Healthcare150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

150

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Respiratory interfaceDEVICE

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

Eligibility

Sex: ALLMax age: 2 Years

Medical Language ↔ Plain English

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

Locations (1)

Mater Mothers' Hospital NICU

Brisbane, Queensland, Australia

Outcomes

Primary Outcomes

Feedback score

Time frame: 12 hours

Central Contacts

Michelle Muir

CONTACT

095740100 michelle.muir@fphcare.co.nz

Data from ClinicalTrials.gov

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