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NCT Number: NCT07250854

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

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.

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Key information

Conditions

Biliary Atresia Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis in Newborn Cholestasis in Newborn Infant Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Kasai

Age range

2 week–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Alabama At Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

samuel hagman, DO

CONTACT

[email protected]

2056389801

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indocyanine green

Drug

Optical imaging agent

Other names: ICG

Primary outcomes

  1. The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia

    Time frame: Within 72 hours

    Measuring stool fluorescence using near infrared imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel Hagman, DO, DO

CONTACT

[email protected]

2056389801

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 26, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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