Recruiting

Observational StudyA Prospective Database of Infants With Cholestasis

Sponsor:

Arbor Research Collaborative for Health

Code:

NCT00061828

Conditions

Biliary Atresia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Biliary Atresia

Study ID

NCT00061828

Start date

Apr 21, 2004

Status verified date

Jun, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Biliary Atresia

Infants presenting with cholestasis who are diagnosed with biliary atresia.

Primary outcome measure

Change in disease severity over time (disease progression) [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Melissa Sexton, BBA, CCRP

734-693-3811 melissa.sexton@arborresearch.org

Melissa Sexton, BBA

734-693-3811 melissa.sexton@arborresearch.org

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Sirikorn Boonsawat

323-361-2181 sboonsawat@chla.usc.edu

Principal Investigator:

Rohit Kohli, MD

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Cynthia Castanon

720-777-0587 Cynthia.castanon@childrenscolorado.org

Michelle Landis

720-777-8884 michelle.landis@childrenscolorado.org

Principal Investigator:

Ronald Sokol, MD

Children's Healthcare of Atlanta - Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Katelynn Harris

404-785-0421 katelynn.harris@choa.org

Jordyn Turner

404-785-3690 jordyn.turner@choa.org

Principal Investigator:

Nitika Gupta, MD

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

Recruiting

Chicago, Illinois, United States, 60614

Contacts

Jacqueline Alexander

312-227-3523 jaalexander@luriechildrens.org

Angela Anthony

312-227-4559 aanthony@luriechildrens.org

Principal Investigator:

Estella Alonso, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Jennifer Hawkins, MS

513-636-7818 jennifer.hawkins@cchmc.org

Erin Chapman, BAS

513-803-7482 erin.chapman@cchmc.org

Principal Investigator:

Alexander Miethke, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Caitlin Griffiths

267-577-9888 griffithc2@chop.edu

Jordan Moreno

267-425-1614 morenoj@chop.edu

Principal Investigator:

Kathleen Loomes, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Laurel Cavallo

832-822-1053 children.network@bcm.edu

Cynthia Tsai, MPH

832-822-3634 children.network@bcm.edu

Principal Investigator:

Paula Hertel, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Ann Rutherford

801-585-9495 ann.rutherford@hsc.utah.edu

Natalie Fillerup

801-587-5670 natalie.fillerup@hsc.utah.edu

Principal Investigator:

Stephen Guthery, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Melissa Young

206-987-1037 melissa.young@seattlechildrens.org

Teresa Chen

206-987-6649 teresa.chen@seattlechildrens.org

Principal Investigator:

Pamela Valentino, MD

More Information

Sponsor

Arbor Research Collaborative for Health

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arbor Research Collaborative for Health on 2026-06-04.