NCT07250854

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 2 Weeks – 4 Months
• Healthy volunteers: Accepted

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.

Conditions

• Biliary Atresia
• Kasai
• Cholestasis in Newborn
• Cholestasis in Newborn Infant

Interventions

Type	Name	Description
DRUG	Indocyanine Green	Optical imaging agent

Timeline

• Start date: 2026-01-23
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-11-26
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study