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Observational Study for Infants with Cholestasis and Suspected Biliary Atresia

This study is creating a database of information from infants with cholestasis (a condition where bile flow from the liver is blocked or reduced), especially those with suspected biliary atresia (a rare liver disease in infants). The goal is to collect clinical details and blood samples to help researchers better understand these liver diseases in children. You may be able to join if your infant is 6 months old or younger, has cholestasis (defined by a specific bilirubin level in their blood), and is suspected of having biliary atresia. The study will track changes in disease severity over time, with follow-up appointments for many years. This is an observational study, meaning no specific treatments are being tested; instead, researchers are gathering information from standard care.

Study design
This is an observational study collecting information from up to 1000 infants. It is not testing a new treatment but rather gathering data to help future research.
What's involved
If your infant has biliary atresia, they will be followed intensively for the first year, then at 18 months, annually up to 10 years, and then every two years. This involves collecting diagnostic, clinical, and outcome data, and blood samples during routine clinical blood draws.
Compensation
Not stated in the trial record.
Follow-up
Participants with biliary atresia will be followed for up to 20 years, or until liver transplantation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00061828

A Prospective Database of Infants With Cholestasis

Recruiting
Not specifiedUp to 6Observational
Arbor Research Collaborative for Health
~1,000 participants
Updated 2026-06-04 on ClinicalTrials.gov

At a glance

Recruiting sites
9 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in disease severity over time (disease progression)
Measured over Measured at baseline, 1 month, 2 months, 3, 6 months post-baseline, 12 and 18 months of age, annually through year 10 and then biannually through year 20.

Conditions

Biliary Atresia

Explore related trials

Biliary Atresia

Where it's being run

16 sites across 14 states
California2
Pennsylvania2
Colorado1
Georgia1
Illinois1
Indiana1
Maryland1
Missouri1

Study leadership

  • Saul Karpen, MD, PhD · STUDY_CHAIR · VCU School of Medicine
  • Ed Doo, MD · STUDY_DIRECTOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • John Magee, MD · PRINCIPAL_INVESTIGATOR · University of Michigan Medical Center, Ann Arbor
  • Lisa Henn, PhD · PRINCIPAL_INVESTIGATOR · Arbor Research Collaborative for Health
  • Katrina Loh, MD · STUDY_DIRECTOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who to contact

Melissa Sexton, BBA, CCRP
[email protected]
734-693-3811
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Infant's age less than or equal to 180 days at initial presentation at the ChiLDReN clinical site.
Diagnosis of cholestasis defined by serum direct or conjugated bilirubin greater than or equal to 2 mg/dl and suspected biliary atresia.
The subject's parent(s)/guardian(s) willing to provide informed written consent.

Exclusion

Acute liver failure.
Previous hepatobiliary surgery with dissection or excision of biliary tissue.
Diagnoses of bacterial or fungal sepsis (except where associated with metabolic liver disease)
Diagnoses of hypoxia, shock or ischemic hepatopathy within the past two weeks (If the cholestasis persists beyond two weeks of the initiating event, the infant can be enrolled).
Diagnosis of any malignancy.
Presence of any primary hemolytic disease (except when diagnosed with biliary atresia or another cholestatic disease being studied by ChiLDREN).
Diagnosis of any drug or Total parenteral nutrition (TPN)-associated cholestasis (except when diagnosed with biliary atresia or another cholestatic disease being studied by ChiLDREN).
Diagnosis with Extracorporeal membrane oxygenation (ECMO)-associated cholestasis.
Birth weight less than 1500g (except when diagnosed with biliary atresia).

What this trial measures

  • Change in disease severity over time (disease progression)Measured at baseline, 1 month, 2 months, 3, 6 months post-baseline, 12 and 18 months of age, annually through year 10 and then biannually through year 20.

    disease progression defined by transplant date, date of death, worsening liver function, and complications related to worsening liver function