Who is sponsoring NCT07250854?

NCT07250854 is sponsored by University of Alabama at Birmingham.

What condition does NCT07250854 study?

NCT07250854 studies Biliary Atresia, Kasai, Cholestasis in Newborn, Cholestasis in Newborn Infant.

What drugs are being tested in NCT07250854?

Interventions: Indocyanine Green.

What is the status of NCT07250854?

NCT07250854 is currently RECRUITING.

Last reviewed 2026-02-16 · How we verify

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

NCT07250854 EARLY_PHASE1 RECRUITING

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.

Details

Lead sponsor	University of Alabama at Birmingham
Phase	EARLY_PHASE1
Status	RECRUITING
Enrolment	15
Start date	2026-01-23
Completion	2027-03

Conditions

Biliary Atresia
Kasai
Cholestasis in Newborn
Cholestasis in Newborn Infant

Interventions

Indocyanine Green

Primary outcomes

The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia — Within 72 hours
Measuring stool fluorescence using near infrared imaging

Countries

United States