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Clinical Trials in Canada / NCT00061828
Recruiting Observational

A Prospective Database of Infants With Cholestasis

NCT00061828 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2004-04-21
Last updated
2026-06-04

Condition(s) studied

Biliary Atresia

Study 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

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)

Trial sites (16)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT00061828 on ClinicalTrials.gov ↗ ← All trials in Canada