Actively Recruiting

Early Phase 1
Age: 2Weeks - 4Months
All Genders
Healthy Volunteers
NCT07250854

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

Led by University of Alabama at Birmingham · Updated on 2026-02-18

15

Participants Needed

1

Research Sites

57 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Weeks - 4Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants admitted to the hospital who a hepatologist deems warrant inpatient work up of neonatal cholestasis suspected to be due to biliary atresia
Not Eligible

You will not qualify if you...

  • Infants not deemed by a hepatologist to need inpatient admission for neonatal cholestasis work up suspected to be biliary atresia
  • Infants managed in the outpatient setting
  • Infants without cholestasis
  • Infants on total parenteral nutrition (TPN) and not eating by mouth for reasons other than temporary imaging or surgery
  • Infants with a history of bowel resection or other surgeries known to introduce blood into the gastrointestinal tract

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Alabama At Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

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Research Team

S

Samuel Hagman, DO, DO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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