Using near infrared spectroscopy to monitor infants with single-ventricle heart disease
Association of Renal Near Infrared Spectroscopy in Outpatients With Parallel Circulation During the Interstage Period and Interstage Morbidity
This study is testing if a special light tool can help monitor the health of infants with single-ventricle heart disease before their surgery to see if it can predict their hospital visits and weight gain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 6 Months |
| Sex | All |
| Sponsor | Advocate Hospital System Academic / other |
| Locations | 1 site (Oak Lawn, Illinois) |
| Trial ID | NCT06538571 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of renal near infrared spectroscopy in outpatient infants with single-ventricle heart disease during the interstage period before the Glenn operation. It aims to correlate the oxygen extraction ratio derived from this spectroscopy with various health outcomes, including the need for hospital admissions and weight gain. Secondary objectives include assessing neurodevelopment and systemic ventricular strain through echocardiography. The study focuses on outpatient infants under six months of age who are awaiting surgical intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under six months of age diagnosed with single-ventricle heart disease who are awaiting the Glenn operation and are currently outpatient.
Not a fit: Patients who may not benefit from this study include those over six months of age, inpatients, or those with specific medical conditions such as ongoing hyperbilirubinemia.
Why it matters
Potential benefit: If successful, this approach could improve monitoring and management of infants with single-ventricle heart disease, potentially reducing hospital admissions and improving health outcomes.
How similar studies have performed: While the use of near infrared spectroscopy is established in various settings, this specific application in outpatient monitoring of single-ventricle heart disease is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oak Lawn, Illinois
- Advocate Childrens Hospital — Oak Lawn, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Wong, MD — Advocate Children's Hospital
- Study coordinator: Joshua Wong, Md
- Email: joshua.wong@aah.org
- Phone: 708-684-5580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.