Association of Near Infrared Spectroscopy With Interstage Outcomes

NCT ID: NCT06538571

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-07-01

Brief Summary

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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

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As above

Conditions

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Single-ventricle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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NIRS use

Patients will have renal near infrared spectroscopy recorded in clinic.

Group Type EXPERIMENTAL

Near infrared spectroscopy

Intervention Type DIAGNOSTIC_TEST

Noninvasive monitor for venous saturation

Interventions

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Near infrared spectroscopy

Noninvasive monitor for venous saturation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advocate Hospital System

OTHER

Sponsor Role lead

Responsible Party

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Joshua Wong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joshua Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Advocate Children's Hospital

Locations

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Advocate Childrens Hospital

Oak Lawn, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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JOSHUA WONG, MD

Role: CONTACT

708-684-5580

Facility Contacts

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Joshua Wong

Role: primary

Other Identifiers

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IRB00111841

Identifier Type: -

Identifier Source: org_study_id

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