Infant Respiratory Interface and Accessories Evaluation Study

NCT ID: NCT05719298

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2026-01-31

Brief Summary

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

Detailed Description

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Conditions

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Respiratory Distress Syndrome, Newborn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Respiratory interface

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

Group Type EXPERIMENTAL

Respiratory interface

Intervention Type DEVICE

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

Interventions

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Respiratory interface

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

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mater Mothers' Hospital NICU

Brisbane, Queensland, Australia

Site Status

Countries

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Australia

Central Contacts

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Michelle Muir

Role: CONTACT

095740100

Other Identifiers

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CIA-235

Identifier Type: OTHER

Identifier Source: secondary_id

UT-1111-1267-0940

Identifier Type: -

Identifier Source: org_study_id

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