The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14 days
Maximum Age: 4 months
Healthy Volunteers: t
View:
• Infants admitted to the hospital (no matter their age, sex, race/ethnicity) who a hepatologist deems warrants inpatient work up of neonatal cholestasis suspected to be due to biliary atresia.
Locations
United States
Alabama
University of Alabama At Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Samuel Hagman, DO, DO
sehagman@uabmc.edu
2056389801
Time Frame
Start Date: 2026-01-23
Estimated Completion Date: 2027-03
Participants
Target number of participants: 15
Treatments
Experimental: Cholestatic infants
infants that are cholestatic needing further work up for biliary atresia
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham