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

Early Phase 1Not Yet RecruitingNCT07250854

University of Alabama at Birmingham15 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Biliary Atresia Kasai Cholestasis in Newborn Cholestasis in Newborn Infant

Interventions

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 4 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia

Measuring stool fluorescence using near infrared imaging

Time frame: Within 72 hours