Association of Near Infrared Spectroscopy With Interstage Outcomes

Part of paid clinical trials in Oak Lawn, Illinois.

Sponsor
Advocate Hospital System
Study ID
NCT06538571
Status
Recruiting
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Conditions

  • Single-ventricle

Eligibility Criteria

Sex
ALL
Age
N/A - 6 Months
Healthy Volunteers
Not accepted

Interventions

  • Near infrared spectroscopy — DIAGNOSTIC_TEST
    Noninvasive monitor for venous saturation

Study Details

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 Dates

First listed
Aug 5, 2024
Start date
Jul 1, 2024
Status verified
Aug 2024
Primary completion
Jul 1, 2025
Completion
Jul 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: NIRS use
    Patients will have renal near infrared spectroscopy recorded in clinic.

Primary Outcome Measure

Unexpected admissions [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Advocate Childrens HospitalOak LawnIllinois60453

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By research site
Advocate Childrens Hospital· Oak Lawn, IL

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