Actively Recruiting

Age: 0 - 6Months
All Genders
NCT00061828

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

Age: 0 - 6Months
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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

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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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A Prospective Database of Infants With Cholestasis | DecenTrialz