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

RecruitingEARLY Phase 1Ages 2 Weeks - 4 MonthsAllUniversity of Alabama at Birmingham
NCT07250854 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Indocyanine Green
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Where

1 site
University of Alabama At Birmingham
Birmingham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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