Recruiting

Observational Study

Sponsor:

Advocate Hospital System

Code:

NCT06538571

Conditions

Single-ventricle

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Near infrared spectroscopy

Study Details

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.

Conditions

Single-ventricle

Study ID

NCT06538571

Start date

Jul 1, 2024

Status verified date

Aug, 2024

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: NIRS use

Patients will have renal near infrared spectroscopy recorded in clinic.

Interventions

Near infrared spectroscopy

Noninvasive monitor for venous saturation

Primary outcome measure

  • Unexpected admissions [ Time Frame: 1 year ]
  • Unexpected interventions [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

JOSHUA WONG, MD

708-684-5580joshua.wong@aah.org

Locations

Advocate Childrens Hospital

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Joshua Wong

joshua.wong@aah.org

More Information

Sponsor

Advocate Hospital System

Last update posted

Aug 7, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Advocate Hospital System on 2024-08-07.