Study of Renal Near Infrared Spectroscopy in Infants With Single Ventricle Heart Disease During the Interstage Outpatient Period

What this Trial Is About

This research aims to evaluate how well renal near infrared spectroscopy NIRS works to monitor infants with single-ventricle heart disease and parallel circulation during the outpatient interstage period before the Glenn operation. The study mainly looks at how the oxygen extraction ratio, calculated from arterial pulse oximetry and renal NIRS values, relates to the need for hospital admission or medical intervention. Researchers will also explore links between this ratio and factors like weight gain, brain development, unexpected hospital visits, heart strain measured by echocardiography, and hospital stays for Glenn surgery. Participants will have their renal NIRS recorded during outpatient clinic visits. This noninvasive test measures venous oxygen saturation to help assess their condition. The study involves monitoring infants under 6 months old who are awaiting the Glenn operation, focusing on their health status in the outpatient setting. No additional treatments or comparators are involved beyond this diagnostic monitoring. During the study, researchers will track unexpected hospital admissions and interventions over one year as primary outcomes. They will also observe secondary health indicators such as growth, neurodevelopment, and heart function by echocardiogram. This ongoing monitoring helps understand the relationship between oxygen extraction ratios and clinical events. The total participation period covers the time before the Glenn operation, with regular outpatient assessments of renal NIRS and clinical status.

Association of Near Infrared Spectroscopy With Interstage Outcomes