Association of Near Infrared Spectroscopy With Interstage... | NCT06538571

Studies
Association of Near Infrared Spectroscopy With Interstage Outcomes

NCT06538571

Sponsor

Advocate Hospital System

Status

Recruiting

Last Update Posted

Aug 7, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Single-ventricle

Interventions

Near infrared spectroscopy

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Actual

Primary Completion Date

Jul 1, 2025Estimated

Completion Date

Jul 1, 2026Estimated

First Submitted Date

Jul 30, 2024

First Submission Date that Met QC Criteria

Aug 1, 2024

First Posted Date

Aug 5, 2024Actual

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 5, 2024

Last Update Posted Date

Aug 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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 assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period. The primary aim will be to determine the correlation between oxygen extraction ratio ((arterial pulse oximetry - renal near infrared spectroscopy value)/arterial pulse oximetry value) with need for inpatient admission or intervention. Secondary aims will be to determine the correlation of the oxygen extraction ratio with weight gain, neurodevelopment, unexpected admissions, systemic ventricular strain by echocardiography, and Glenn hospitalization admission characteristics.

Detailed Description

As above

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NIRS use	Experimental	Patients will have renal near infrared spectroscopy recorded in clinic.	Diagnostic Test: Near infrared spectroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Near infrared spectroscopy	Diagnostic Test	Noninvasive monitor for venous saturation	NIRS use

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Unexpected admissions	The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected admissions during the interstage period.	1 year
Unexpected interventions	The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected need for interventions such as cardiac catheterization interventions or surgical interventions	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants under 6 months of age
Infants with single ventricle heart disease and parallel circulation
Infants who are awaiting the Glenn operation
Infants who are outpatient

Exclusion Criteria:

Infants over 6 months of age
Inpatients
Infants with history of skin injury from the near infrared spectroscopy sensor inpatient
Infants with ongoing hyperbilirubinemia

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
JOSHUA WONG, MD	Contact	708-684-5580		joshua.wong@aah.org

Overall Officials

Name	Affiliation	Role
Joshua Wong, MD	Advocate Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Advocate Childrens Hospital	Recruiting	Oak Lawn	Illinois	60453	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

Condition Browse Module

MeSH Terms

ID	Term
D000080039	Univentricular Heart

Ancestor Terms

ID	Term
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019265	Spectroscopy, Near-Infrared

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D013057	Spectrum Analysis

Browse Leaves

Not provided

Browse Branches

Not provided