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Near-Infrared Fluorescence Cholangiography for Neonatal Cholestasis

This study is investigating a new way to help diagnose biliary atresia (a rare liver disease in infants) in newborns with cholestasis (a condition where bile flow from the liver is reduced or blocked). It uses a special dye called Indocyanine Green (ICG). If your infant is admitted to the hospital because doctors suspect biliary atresia, they might be eligible to join. Your infant would receive a one-time IV (intravenous) dose of ICG. Doctors will then check your infant's diapers for the dye, which helps show if bile is flowing. The study aims to see how accurate this method is in diagnosing biliary atresia. We don't know the current recruitment status.

Study design
This is an interventional study with a planned enrollment of 15 infants. It is not specified if it is randomized or blinded.
What's involved
Your infant would receive a one-time intravenous (IV) dose of Indocyanine Green (ICG). Their diapers would then be examined for the presence of the dye.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, accuracy of ICG fluorescence, is measured within 72 hours.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07250854

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

Recruiting
EARLY_PHASE1Ages 2–4InterventionalDiagnostic
University of Alabama at Birmingham
~15 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:Indocyanine Green

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia
Measured over Within 72 hours

Conditions

Biliary Atresia
Kasai
Cholestasis in Newborn
Cholestasis in Newborn Infant

Explore related trials

Biliary AtresiaCholestasis in newborn

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Laura Stafman, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Samuel Hagman, DO, DO
[email protected]
2056389801
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • The number and accuracy of ICG fluorescence in the diagnosis of biliary atresiaWithin 72 hours

    Measuring stool fluorescence using near infrared imaging