An Early Phase 1 interventional study of Indocyanine Green in Biliary Atresia, Kasai and Cholestasis in Newborn, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 2 Weeks to 4 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by University of Alabama at Birmingham · Early Phase 1, Interventional, and Diagnostic
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.
77 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.
This study's planned enrollment of 15 is below the median of 45 across 43 interventional studies indexed under Biliary Atresia.
Browse Biliary Atresia studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
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Exclusion Criteria:
infants that are cholestatic needing further work up for biliary atresia
Drug: Indocyanine Green
Optical imaging agent
Also known as: ICG
The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia
Measuring stool fluorescence using near infrared imaging
Time frame: Within 72 hours
Plan to share: No
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Studies of the drug tested here: Indocyanine Green
University of Alabama at Birmingham →