Association of Near Infrared Spectroscopy With Interstage Outcomes

August 5, 2024 updated by: Joshua Wong, Advocate Hospital System

Association of Renal Near Infrared Spectroscopy in Outpatients With Parallel Circulation During the Interstage Period and Interstage Morbidity

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

As above

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIRS use
Patients will have renal near infrared spectroscopy recorded in clinic.
Diagnostic test: Near infrared spectroscopy
Noninvasive monitor for venous saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unexpected admissions
Time Frame: 1 year
The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected admissions during the interstage period.
1 year
Unexpected interventions
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advocate Hospital System

Investigators

  • Principal Investigator: Joshua Wong, MD, Advocate Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00111841

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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