RecruitingNCT00061828

A Prospective Database of Infants With Cholestasis

Childhood Liver Disease Research Network (ChiLDReN): A Prospective Database of Infants With Cholestasis


Sponsor

Arbor Research Collaborative for Health

Enrollment

1,000 participants

Start Date

Apr 21, 2004

Study Type

OBSERVATIONAL

Conditions

Summary

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

Max Age: 6 Months

Plain Language Summary

Simplified for easier understanding

This study builds a database to track infants with cholestasis (a condition where bile doesn't flow properly from the liver) and suspected biliary atresia (a blockage of the bile ducts). Researchers want to better understand the causes, progression, and outcomes of these rare liver diseases in newborns. You may be eligible if: - Your infant is 6 months old or younger at the time of first presentation at a participating clinic - Your infant has elevated direct or conjugated bilirubin (≥2 mg/dL) with suspected biliary atresia - You (the parent/guardian) are willing to provide written informed consent You may NOT be eligible if: - Your infant has acute liver failure - Your infant has had prior hepatobiliary surgery involving removal of bile duct tissue - Your infant has bacterial or fungal sepsis, hypoxia/shock within the past 2 weeks, a diagnosed malignancy, primary hemolytic disease, drug- or TPN-associated cholestasis, or ECMO-associated cholestasis - Your infant's birth weight was less than 1,500 grams (unless biliary atresia is diagnosed) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(16)

Children's Hospital Los Angeles

Los Angeles, California, United States

University of California

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's Healthcare of Atlanta - Emory University

Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 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

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

The Hospital for Sick Children

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT00061828


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