Infant Respiratory Interface and Accessories Evaluation Study

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05719298

Enrollment

150

Registered

2023-02-08

Start date

2023-02-28

Completion date

2026-01-31

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Newborn

Brief summary

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

Interventions

DEVICERespiratory interface

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Years

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

Design outcomes

Primary

Measure	Time frame
Feedback score	12 hours

Countries

Australia

Contacts

Primary ContactMichelle Muir

michelle.muir@fphcare.co.nz095740100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026