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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07250854

Enrollment

Registered

2025-11-26

Start date

2026-01-23

Completion date

2027-03-01

Last updated

2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia, Cholestasis in Newborn, Cholestasis in Newborn Infant, Kasai

Keywords

biliary atresia, kasai, cholestasis, cholestasis in neonate, cholestasis in newborn, direct bilirubin, acholic stool

Brief summary

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.

Interventions

DRUGIndocyanine Green

Optical imaging agent

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Weeks to 4 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia	Within 72 hours	Measuring stool fluorescence using near infrared imaging

Countries

United States

Contacts

CONTACTSamuel Hagman, DO, DO

sehagman@uabmc.edu2056389801

PRINCIPAL_INVESTIGATORLaura Stafman, MD

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026