Actively Recruiting

Phase Not Applicable
Age: 0 - 6Months
All Genders
ID06538571

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

Age: 0 - 6Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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

Long-term 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

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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

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