Actively Recruiting
Association of Renal Near Infrared Spectroscopy in Outpatients With Parallel Circulation During the Interstage Period and Interstage Morbidity
Led by Advocate Hospital System · Updated on 2024-08-07
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Association of Near Infrared Spectroscopy With Interstage Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Infants over 6 months of age
- Inpatients
- Infants with history of skin injury from the near infrared spectroscopy sensor inpatient
- Infants with ongoing hyperbilirubinemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants have renal near infrared spectroscopy recorded in the clinic as a noninvasive monitor for venous saturation during the interstage period.
Regular clinic visits for monitoring
Duration - Up to 1 year
Participants are monitored for unexpected hospital admissions and interventions during the interstage period after diagnostic evaluation.
Trial Site Locations
Total: 1 location
1
Advocate Childrens Hospital
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
Research Team
J
JOSHUA WONG, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here