The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis

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.

NCT Number	NCT07250854
Lead Sponsor	University of Alabama at Birmingham
Conditions	Biliary Atresia, Kasai, Cholestasis in Newborn, Cholestasis in Newborn Infant
Enrollment	15 participants
Start Date	2026-01-23
Primary Completion	2027-03 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-02-18