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Near Infrared Spectroscopy for Single Ventricle Heart

N/A
Recruiting
Led By Joshua Wong, MD
Research Sponsored by Advocate Hospital System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants under 6 months of age
Infants with single ventricle heart disease and parallel circulation
Must not have
Infants over 6 months of age
Infants with ongoing hyperbilirubinemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a new technology called renal near infrared spectroscopy can help predict if a patient will need to be admitted to the hospital or need medical intervention. Other goals of the study include

Who is the study for?
This trial is for individuals with a heart condition known as Single Ventricle Heart. It's specifically looking at patients in the interstage period, which is the time between their first and second heart surgeries.
What is being tested?
The study tests how well renal near infrared spectroscopy (a non-invasive method to monitor oxygen levels in tissues) can predict hospital admissions or interventions during outpatient care in this patient group.
What are the potential side effects?
Since near infrared spectroscopy is a non-invasive monitoring technique, it typically does not have direct side effects. However, any discomfort or issues related to wearing the device will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is younger than 6 months.
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My infant has a specific heart condition with one working chamber.
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My infant is scheduled for the Glenn operation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My child is older than 6 months.
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My infant has ongoing jaundice.
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I am currently hospitalized.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Unexpected admissions
Unexpected interventions

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NIRS useExperimental Treatment1 Intervention
Patients will have renal near infrared spectroscopy recorded in clinic.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Near infrared spectroscopy
2020
N/A
~200

Find a Location

Who is running the clinical trial?

Advocate Hospital SystemLead Sponsor
5 Previous Clinical Trials
718 Total Patients Enrolled
Joshua Wong, MDPrincipal InvestigatorAdvocate Children's Hospital
~12 spots leftby Jul 2025
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