A Prospective Database of Infants With Cholestasis

Recruiting now

Conditions studied: Biliary Atresia

In brief

Biliary atresia, idiopathic neonatal hepatitis, and specific genetic cholestatic conditions are the most common causes of jaundice and hyperbilirubinemia that continue beyond the newborn period. The long term goal of the Childhood Liver Disease Research Network (ChiLDReN) is to establish a database of clinical information and plasma, serum, and tissue samples from cholestatic children to facilitate research and to perform clinical, epidemiological and therapeutic trials in these important pediatric liver diseases.

Key facts

Study ID

NCT00061828

Run by

Arbor Research Collaborative for Health

People needed

1000

Starts

2004-04-21

Expected to finish

2029-05-31

Last updated by the study team

2026-06-04

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Children's Healthcare of Atlanta - Emory University — Atlanta, Georgia, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• The Hospital for Sick Children — Toronto, Ontario, Canada
• University of California — San Francisco, California, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mount Sinai Medical Center — New York, New York, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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