Association of Near Infrared Spectroscopy With Interstage Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Near infrared spectroscopy.
- Who it may be relevant to
- Registry conditions: Single-ventricle. Basic parameters: up to 6 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Association of Renal Near Infrared Spectroscopy in Outpatients With Parallel Circulation During the Interstage Period and Interstage Morbidity
Overview
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
As above
Interventions
- Diagnostic test Near infrared spectroscopy
Noninvasive monitor for venous saturation
Primary outcome measures
- Unexpected admissions [Time frame: 1 year]
- Unexpected interventions [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Advocate Childrens Hospital — Oak Lawn
Identifiers
NCT: NCT06538571 · IRB00111841