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Diaper dye could spot deadly infant liver disease

NCT ID NCT07250854

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

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 weeks to 4 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Alabama At Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

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