Association of Near Infrared Spectroscopy With Interstage Outcomes

NCT06538571 | Recruiting FDA Device

• 1 other identifier: IRB00111841
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Unexpected admissions

  The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected admissions during the interstage period.

  1 year

• Unexpected interventions

  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

  1 year

Study Arms (1)

NIRS use

EXPERIMENTAL

Patients will have renal near infrared spectroscopy recorded in clinic.

Diagnostic Test: Near infrared spectroscopy

Interventions

Near infrared spectroscopy DIAGNOSTIC_TEST

Noninvasive monitor for venous saturation

NIRS use

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• Advocate Hospital System: lead

Study Sites (1)

Advocate Childrens Hospital

Oak Lawn, Illinois, 60453, United States

RECRUITING

MeSH Terms

Conditions

Univentricular Heart

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Joshua Wong, MD

  Advocate Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JOSHUA WONG, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 5, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)