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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07250854
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Biliary Atresia
  • Cholestasis in Newborn
  • Cholestasis in Newborn Infant
  • Kasai

Eligibility Criteria

Sex
ALL
Age
2 Weeks - 4 Months
Healthy Volunteers
Accepted

Interventions

  • Indocyanine Green — DRUG
    Optical imaging agent

Study Details

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.

Key Dates

Start date
Jan 23, 2026
Status verified
Nov 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cholestatic infants
    infants that are cholestatic needing further work up for biliary atresia

Primary Outcome Measure

The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia [ Time Frame: Within 72 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama At BirminghamBirminghamAlabama35233
samuel hagman, DO
[email protected]
2056389801

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By research site
University of Alabama At Birmingham· Birmingham, AL

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