Work of Breathing and Oxygen Saturation in Infants Receiv... | NCT03529994

Studies
Work of Breathing and Oxygen Saturation in Infants Receiving High Flow Nasal Cannula (HFNC)

NCT03529994

Sponsor

Christiana Care Health Services

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

30Actual

Phase

Not provided

Conditions

High Flow Nasal Cannula

Interventions

Enrollment

Countries

United States

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

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2018Actual

Primary Completion Date

Jul 31, 2019Actual

Completion Date

Aug 1, 2019Actual

First Submitted Date

May 8, 2018

First Submission Date that Met QC Criteria

May 8, 2018

First Posted Date

May 21, 2018Actual

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

Aug 27, 2019

Last Update Posted Date

Aug 28, 2019Actual

Name	Class
Alfred I. duPont Hospital for Children	OTHER

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

The purpose of this study is to compare work of breathing on different levels of high flow respiratory support on infants born between 27 and 37 weeks gestation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enrollment			Other: Enrollment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enrollment	Other	All infants enrolled will have work of breathing assessed.	Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Work of breathing indices	Altering HFNC flow rates and its effect on work of breathing indices in preterm infants with respiratory insufficiency.	2 hours

Secondary Outcomes

Measure	Description	Time Frame
Intermittent hypoxia	Altering HFNC flow rates and its effect on intermittent hypoxia in preterm infants with respiratory insufficiency.	2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants between 27 and 37 weeks corrected gestational age
>4 days PNA
Stable (i.e. not meeting exclusion criteria) and receiving non-invasive respiratory support (HFNC) for ≥ 12 hours
Requiring ≤ 40% supplemental FiO2 as determined by the clinical care team for clinical care purposes independent of this study

Exclusion Criteria:

Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of WOB measurements

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Convenience sample of infants on HFNC admitted to our NICU who meet inclusion criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kelley Kovatis, MD	Christiana Care Health Services, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christiana Care Health Services, Inc.		Newark	Delaware	19718	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided