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

NCT07250854 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: IRB-30015542UAB
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Atresia; Kasai; Cholestasis in Newborn; Cholestasis in Newborn Infant

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Measuring stool fluorescence using near infrared imaging

  Within 72 hours

Study Arms (1)

Cholestatic infants

EXPERIMENTAL

infants that are cholestatic needing further work up for biliary atresia

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

Optical imaging agent

Also known as: ICG

Cholestatic infants

Eligibility Criteria

• Age: 2 Weeks - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama At Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Biliary Atresia; Cholestasis

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Laura Stafman, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Hagman, DO, DO

CONTACT

2056389801; sehagman@uabmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)