PROBE: A Prospective Database of Infants With Cholestasis



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:2/21/2018
Start Date:May 2004
End Date:May 2019
Contact:Peg Hill-Callahan, BS
Email:peg.hill-callahan@arborresearch.org
Phone:734 369-9674

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Childhood Liver Disease Research and Education Network (CHILDREN): A Prospective Database of Infants With Cholestasis

Biliary atresia and idiopathic neonatal hepatitis are the most common causes of jaundice and
hyperbilirubinemia that continue beyond the newborn period. The long term goal of the Biliary
Atresia Research Consortium (BARC) is to establish a database of clinical information and
serum and tissue samples from children with biliary atresia (BA) and idiopathic neonatal
hepatitis (INH) to facilitate research and to perform clinical, epidemiological and
therapeutic trials in these two important pediatric liver diseases.

This is a multi-center project to establish a prospective database of clinical information
and a repository of blood and tissue samples from children with diagnoses of neonatal liver
diseases, such as biliary atresia and neonatal hepatitis, in order to perform research in
these important liver problems. Children will be screened and enrolled at presentation at the
participating pediatric liver sites. Subjects diagnosed with biliary atresia will be followed
intensively for the first year, at 18 months of age, and then annually up to 15 years of age.
Other subjects diagnosed with cholestasis will be followed on the same schedule; if there is
complete (clinical and biochemical) resolution of their underlying liver disease off all
therapy, there will be one follow up visit within one year (preferably scheduled at the time
of the next planned follow up visit or at 12 months of age, whichever is later) for data
collection and to obtain blood samples. The development of a serum and tissue bank of
specimens from children with various neonatal cholestatic disorders will be an invaluable
tool for current and future investigations into the etiology and pathogenesis of
hepatobiliary injury in the infant.

Detailed clinical data, laboratory investigations, liver biopsy specimens, and long-term
follow-up of outcomes are part of the normal standard of care with respect to the diagnosis
and treatment of the subjects with liver problems. This research involves the collection of
diagnostic, clinical and outcome data concerning the subject, which is kept without
identification (coded) in a national research database of infants with liver disease. Samples
of blood and urine will be obtained for later research analysis, whenever possible, at the
time of clinically indicated blood draws or when there is IV access for a clinical procedure.
When liver biopsy specimens are obtained for diagnostic purposes, any liver biopsy specimen
in excess of that needed for diagnostic use will be sent to the tissue repository. When a
portoenterostomy or liver transplant occurs, sections of the liver, biliary remnant and bile
specimens, if removed in the course of surgery and in excess of that needed for diagnostic
use, will be sent for the repository. These specimens will be used in investigations into the
mechanisms and causes of the liver damage that occur in the subject's condition. As part of
the standard of care, the study will follow-up and record progress of the liver problem by
routine clinical examinations and laboratory tests for up to 15 years. All data from this
study will be kept in a secure research database at the data coordinating center.

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
20% of total and greater than or equal to 2 mg/dl.

- 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 TPN-associated cholestasis (except when diagnosed with
biliary atresia or another cholestatic disease being studied by ChiLDREN).

- Diagnosis with ECMO-associated cholestasis.

- Birth weight less than 1500g (except when diagnosed with biliary atresia).
We found this trial at
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Baltimore, Maryland 21287
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Phone: 832-822-3634
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Kasper Wang, MD
Phone: 323-361-4566
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Kathleen Loomes, MD
Phone: 215-590-2525
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Stephen Guthery, MD
Phone: 801-585-9495
University of Utah Research is a major component in the life of the U benefiting...
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Atlanta, Georgia 30322
Principal Investigator: Saul Karpen, MD, PhD
Phone: 404-785-1467
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Ronald Sokol, MD
Phone: 720-777-4690
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Estella Alonso, MD
Phone: 312-227-3523
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Cincinnati, Ohio 45229
Principal Investigator: Jorge Bezerra, MD
Phone: 513-636-7818
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Jean Molleston, MD
Phone: 317-944-1421
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Robert Squires, Jr, MD
Phone: 412-692-7703
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94143
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Karen Murray, MD
Phone: 206-987-1037
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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555 University Avenue
Toronto, Ontario M5G 1X8
Phone: 416-813-7654
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