Association of Near Infrared Spectroscopy With Interstage Outcomes

Recruiting now · Not applicable

Conditions studied: Single-ventricle

In brief

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.

Key facts

Study ID

NCT06538571

Run by

Advocate Hospital System

People needed

20

Starts

2024-07-01

Expected to finish

2026-07-01

Last updated by the study team

2024-08-07

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Advocate Childrens Hospital — Oak Lawn, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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