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

The University of Alabama at Birmingham

Status and phase

Begins enrollment this month

Early Phase 1

Conditions

Cholestasis in Newborn Infant

Kasai

Cholestasis in Newborn

Biliary Atresia

Treatments

Drug: Indocyanine Green

Study type

Interventional

Funder types

Other

Identifiers

NCT07250854

IRB-30015542

UAB (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment

15 estimated patients

Sex

All

Ages

2 weeks to 4 months old

Volunteers

Accepts Healthy Volunteers

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.