Infant Respiratory Interface and Accessories Evaluation S... | NCT05719298

Studies
Infant Respiratory Interface and Accessories Evaluation Study

NCT05719298

Sponsor

Fisher and Paykel Healthcare

Status

Unknown status

Last Update Posted

Feb 8, 2023Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Respiratory interface

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CIA-235	Other Identifier	Fisher & Paykel Healthcare

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2023Estimated

Primary Completion Date

Jan 2026Estimated

Completion Date

Jan 2026Estimated

First Submitted Date

Jan 31, 2023

First Submission Date that Met QC Criteria

Jan 31, 2023

First Posted Date

Feb 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2023

Last Update Posted Date

Feb 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Respiratory interface	Experimental	Use of the new respiratory interface and accessories to deliver non-invasive therapy	Device: Respiratory interface

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Respiratory interface	Device	Application of the new interface and accessories and provision of non-invasive respiratory support through the device.	Respiratory interface

Measure	Description	Time Frame
Feedback score		12 hours

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michelle Muir	Contact	095740100		michelle.muir@fphcare.co.nz

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mater Mothers' Hospital NICU		Brisbane	Queensland	4101	Australia

Condition Browse Module

MeSH Terms

ID	Term
D012127	Respiratory Distress Syndrome, Newborn

Ancestor Terms

ID	Term
D012128	Respiratory Distress Syndrome
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided