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Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 2 Weeks to 4 Months

Using near-infrared ICG dye to check bile flow in newborns with cholestasis

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

Run by University of Alabama at Birmingham · NCT07250854 · Data updated 2026-11-12

We will give eligible newborns a single IV dose of indocyanine green (ICG) to see if the dye appears in their diapers, which would indicate bile is flowing and the bile ducts are open.

More Biliary Atresia trials

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages2 Weeks to 4 Months
SexAll
Enrollment15 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Locations1 site (Birmingham, Alabama)
StatusRecruiting
StartedJanuary 23, 2026
Main results expectedMarch 2027
Study endsMarch 2027
Registry record updatedFebruary 18, 2026
Trial IDNCT07250854 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Infants admitted for inpatient workup of cholestasis with clinical concern for biliary atresia, who are not on prolonged TPN and have no history of bowel resection, are ideal candidates.

Probably not a fit

Infants managed entirely as outpatients, those without cholestasis, infants on prolonged TPN and NPO for non-temporary reasons, or those with prior bowel surgery are unlikely to benefit from this test.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center early-phase study at the University of Alabama at Birmingham will administer a one-time intravenous dose of indocyanine green (ICG) to infants admitted for an inpatient workup of neonatal cholestasis when biliary atresia is suspected. Clinical staff will subsequently examine diapers for fluorescent ICG as a sign of bile excretion and biliary patency. The protocol excludes outpatients, infants on prolonged TPN who are NPO for non-temporary reasons, and infants with prior bowel surgery that can introduce blood into the gastrointestinal tract. The team aims to reproduce previously reported high accuracy of ICG dye detection to inform faster, less invasive diagnostic pathways for neonatal cholestasis.

Why it matters

Potential benefit: If successful, this could provide a quick bedside, noninvasive way to confirm bile flow and reduce the need for more invasive testing or diagnostic delays.

How similar studies have gone: Previous reports described near-infrared ICG detection in stool as about 97% accurate for biliary patency, but data specifically in the neonatal inpatient population are limited and this study seeks to replicate those findings.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • University of Alabama At Birmingham
    Birmingham, Alabama, United States     Recruiting

Study contacts

  • Principal investigator: Laura Stafman, MD — University of Alabama at Birmingham
  • Study coordinator: Samuel Hagman, DO, DO
  • Email: sehagman@uabmc.edu
  • Phone: 2056389801

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.