Diaper dye could spot deadly infant liver disease

NCT ID NCT07250854

Recruiting now Diagnosis Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a simple method to diagnose biliary atresia, a serious liver condition in newborns. Infants with suspected cholestasis receive a dye called indocyanine green (ICG) through an IV. Doctors then check the baby's diaper for the dye, which would indicate bile is flowing properly. The goal is to see if this non-invasive test can accurately identify blocked bile ducts, helping doctors decide on treatment faster.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Indocyanine Green (ICG) dye
What this could lead to: If successful, this could provide a simple, non-invasive way to diagnose biliary atresia in newborns, potentially reducing the need for more invasive tests.
What could go wrong: This is a very small, early-phase study with only 15 infants, so results may not apply to all cases. The test's accuracy needs confirmation, and it may not replace standard diagnostic procedures.

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Conditions

The condition(s) this trial relates to.

biliary atresia cholestasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BILIARY ATRESIA CHOLESTASIS IN NEWBORN CHOLESTASIS IN NEWBORN INFANT KASAI

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

University of Alabama At Birmingham
RECRUITING

Birmingham, Alabama, 35233, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••

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