Association of Near Infrared Spectroscopy With Interstage Outcomes
ConditionSingle-ventricle
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorAdvocate Hospital System
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Infants over 6 months of age
Inpatients
Infants with history of skin injury from the near infrared spectroscopy sensor inpatient
Infants with ongoing hyperbilirubinemia
Trial design
Treatments tested in this trial
- Near infrared spectroscopy
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov