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RECRUITING
NCT07250854
EARLY_PHASE1

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

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

2 Weeks - 4 Months

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-01-23

Completion Date

2027-03

Last Updated

2026-02-18

Healthy Volunteers

Yes

Interventions

DRUG

Indocyanine Green

Optical imaging agent

Locations (1)

University of Alabama At Birmingham

Birmingham, Alabama, United States