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RecruitingAccepts healthy volunteersEarly Phase 1

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

University of Alabama at Birmingham · NCT07250854

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 0 mo–4 mo · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
15
US sites recruiting
1
Study start
January 23, 2026
Record last updated
February 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Indocyanine Green

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of Alabama At Birmingham

    Birmingham, AL 35233

    Site contact: samuel hagman, DO · 2056389801 · sehagman@uabmc.edu

Study contacts (from the official record)

  • Samuel Hagman, DO, DO · 2056389801 · sehagman@uabmc.edu
All healthy volunteers studies in Alabama →
The Use of Near-Infrared Fluorescence Cholangiography With… (NCT07250854) | Bored Studies