About this trial
In infants that present with findings concerning for biliary atresia, along with other cholestatic work up which is standard, they will receive a one-time intravenous (IV) dose of Indocyanine Green (ICG). The infant's diapers will subsequently be examined for presence of the ICG, and if present, suggests bile flow. This was described as 97% accurate for assessing biliary patency and we would like to perform a similar study to assess biliary patency in the work up of neonatal cholestasis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Infants admitted to the hospital (no matter their age, sex, race/ethnicity) who a hepatologist deems warrants inpatient work up of neonatal cholestasis suspected to be due to biliary atresia.
Disqualifiers
Infants that a hepatologist has not deemed to warrant inpatient admission for work up of neonatal cholestasis suspected to be due to biliary atresia.
Infants that are managed in the outpatient setting
Non-cholestatic infants
Patient who are on TPN AND NPO for reasons other than temporary imaging or surgical requirements
Trial design
Single group
Treatments tested in this trial
Indocyanine Green
DrugOptical imaging agent
Treatment groups
Trial outcomes
Primary outcomes
The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia
Measuring stool fluorescence using near infrared imaging
Sponsors and contacts
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