Actively Recruiting
The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis
Led by University of Alabama at Birmingham · Updated on 2026-02-18
15
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants admitted to the hospital who a hepatologist deems warrant inpatient work up of neonatal cholestasis suspected to be due to biliary atresia
You will not qualify if you...
- Infants not deemed by a hepatologist to need inpatient admission for neonatal cholestasis work up suspected to be biliary atresia
- Infants managed in the outpatient setting
- Infants without cholestasis
- Infants on total parenteral nutrition (TPN) and not eating by mouth for reasons other than temporary imaging or surgery
- Infants with a history of bowel resection or other surgeries known to introduce blood into the gastrointestinal tract
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama At Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
S
Samuel Hagman, DO, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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