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NCT Number: NCT06538571

Association of Near Infrared Spectroscopy With Interstage Outcomes

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.

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Key information

Conditions

Single-ventricle Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Univentricular Heart

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advocate Childrens Hospital

Oak Lawn, Illinois, 60453, United States

Location status: Recruiting

Location contact

Joshua Wong

CONTACT

[email protected]

About this study

As above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near infrared spectroscopy

Diagnostic Test

Noninvasive monitor for venous saturation

Primary outcomes

  1. Unexpected admissions

    Time frame: 1 year

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

  2. Unexpected interventions

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

JOSHUA WONG, MD

CONTACT

[email protected]

708-684-5580

Sponsors and collaborators

Lead sponsor

Advocate Hospital System

Other

Registry information

Official study title

Association of Renal Near Infrared Spectroscopy in Outpatients With Parallel Circulation During the Interstage Period and Interstage Morbidity

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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