Association of Near Infrared Spectroscopy With Interstage Outcomes

Not Applicable

Recruiting

• Conditions: Single-ventricle
• Interventions: Diagnostic Test: Near infrared spectroscopy

• Registration Number: NCT06538571
• Lead Sponsor: Advocate Hospital System

Brief Summary

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.

Detailed Description

As above

Study Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-07-30
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-05
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NIRS use	Near infrared spectroscopy	Patients will have renal near infrared spectroscopy recorded in clinic.

Primary Outcome Measures

Name	Time	Method
Unexpected admissions	1 year	The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected admissions during the interstage period.
Unexpected interventions	1 year	The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected need for interventions such as cardiac catheterization interventions or surgical interventions

Trial Locations

Locations (1)

Advocate Childrens Hospital; 🇺🇸 Oak Lawn, Illinois, United States