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

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

Recruiting
2-4 years
All
Phase 0

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Overview

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

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.

Study details
    Biliary Atresia
    Kasai
    Cholestasis in Newborn
    Cholestasis in Newborn Infant

NCT07250854

University of Alabama at Birmingham

14 May 2026

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