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.
Eligibility
Sex
ALL
Min age
—
Max age
6 Months
Healthy volunteers
No
INCLUSION CRITERIA
* 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 CRITERIA
* 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).
Primary outcome measure(s)
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
Trial sites (16)
Facility
City
Region
Status
Children's Hospital Los Angeles
Los Angeles
California
Recruiting
University of California
San Francisco
California
Completed
Children's Hospital Colorado
Aurora
Colorado
Recruiting
Children's Healthcare of Atlanta - Emory University
Atlanta
Georgia
Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Illinois
Recruiting
Riley Hospital for Children
Indianapolis
Indiana
Completed
Johns Hopkins School of Medicine
Baltimore
Maryland
Completed
Washington University School of Medicine
St Louis
Missouri
Completed
Mount Sinai Medical Center
New York
New York
Completed
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
Recruiting
Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh
Pennsylvania
Completed
Baylor College of Medicine
Houston
Texas
Recruiting
University of Utah
Salt Lake City
Utah
Recruiting
Seattle Children's Hospital
Seattle
Washington
Recruiting
The Hospital for Sick Children
Toronto
Ontario
Completed
More Arbor Research Collaborative for Health trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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