Actively Recruiting
A Prospective Database of Infants With Cholestasis
Led by Arbor Research Collaborative for Health · Updated on 2025-10-15
1000
Participants Needed
16
Research Sites
1310 weeks
Total Duration
On this page
Sponsors
A
Arbor Research Collaborative for Health
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective Database of Infants With Cholestasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 (unless cholestasis persists beyond two weeks).
- Diagnosis of any malignancy.
- Presence of any primary hemolytic disease (except when diagnosed with biliary atresia or another cholestatic disease studied by ChiLDReN).
- Diagnosis of any drug or Total parenteral nutrition (TPN)-associated cholestasis (except when diagnosed with biliary atresia or another cholestatic disease studied by ChiLDReN).
- Diagnosis with Extracorporeal membrane oxygenation (ECMO)-associated cholestasis.
- Birth weight less than 1500g (except when diagnosed with biliary atresia).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
University of California
San Francisco, California, United States, 94143
Completed
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Children's Healthcare of Atlanta - Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614
Actively Recruiting
6
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Completed
7
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Completed
8
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Completed
9
Mount Sinai Medical Center
New York, New York, United States, 10029
Completed
10
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
11
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
13
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
14
University of Utah
Salt Lake City, Utah, United States, 84113
Actively Recruiting
15
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
16
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Completed
Research Team
T
Terese A Howell, BS
CONTACT
M
Melissa Sexton, BBA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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