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

RecruitingEarly phase 1Healthy volunteers welcome

Who can join

2 Weeks – 4 Months · All sexes · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Infants that a hepatologist has not deemed to warrant inpatient admission for work up of neonatal cholestasis suspected to be due to biliary atresia.
* Infants that are managed in the outpatient setting
* Non-cholestatic infants
* Patient who are on TPN AND NPO for reasons other than temporary imaging or surgical requirements
* Infant with a history of bowel resection or other surgical procedures known to introduce blood into the gastrointestinal tract.

About the study

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.

What is being tested

Sponsor: University of Alabama at Birmingham · Participants: 15 · Started: Jan 23, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07250854

Locations in the U.S.

AlabamaUniversity of Alabama At Birmingham, Birmingham

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.