Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1265 participants
OBSERVATIONAL
2006-05-16
2029-05-31
Brief Summary
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Detailed Description
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The purpose of this study is to collect the pertinent clinical information, genetic material and body fluid samples to enable investigators to address the following hypotheses:
Hypothesis 1: A genetic defect is a likely causative factor for BA among children with BA and multiple congenital anomalies.
Hypothesis 2a: Sentinel events such as variceal bleeding, ascites and growth failure are earlier predictors of death or need for liver transplantation than the pediatric end-stage liver disease score (PELD).
Hypothesis 2b: Health related quality of life will be impaired compared to healthy age matched children and relate to severity of illness.
Hypothesis 2c: Growth failure as measured by anthropometrics and nutritional supplementation will be predictive of onset of sentinel events (ascites, variceal bleed, death, and transplant) in the following 24 months.
This study will be performed by the Childhood Liver Disease Research Network (ChiLDReN), a National Institute of Diabetes \& Digestive and Kidney Diseases (NIDDK) funded network.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Biliary atresia subjects who have their native liver
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Participants need to be \>6 months of age up to and equal to the age of 20 (participants enrolled at 20 years of age will have one visit).
3. Participants with their native liver.
4. Parent, guardian or participant (if 18 years of age or older) is willing to provide informed consent and, when appropriate, the participant is willing to assent.
Exclusion Criteria
2. Inability to confirm original diagnostic evaluation of biliary atresia.
3. Inability or unwillingness of family or participant to participate in all scheduled visits.
4. History of liver transplantation.
6 Months
20 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Arbor Research Collaborative for Health
OTHER
Responsible Party
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Principal Investigators
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Sanjiv Harpavat, MD
Role: STUDY_CHAIR
Texas Children's/Baylor College of Medicine
Ed Doo, MD
Role: STUDY_DIRECTOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
John C Magee, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Lisa Henn, PhD
Role: PRINCIPAL_INVESTIGATOR
Arbor Research Collaborative for Health - Data Coordinating Center
Katrina Loh, MD
Role: STUDY_DIRECTOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's Healthcare of Atlanta - Emory University
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Children's Hospital
Indianapolis, Indiana, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mount Sinai Medical Center
New York, New York, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Texas Children's Hospital (Baylor College of Medicine)
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Ng VL, Haber BH, Magee JC, Miethke A, Murray KF, Michail S, Karpen SJ, Kerkar N, Molleston JP, Romero R, Rosenthal P, Schwarz KB, Shneider BL, Turmelle YP, Alonso EM, Sherker AH, Sokol RJ; Childhood Liver Disease Research and Education Network (CHiLDREN). Medical status of 219 children with biliary atresia surviving long-term with their native livers: results from a North American multicenter consortium. J Pediatr. 2014 Sep;165(3):539-546.e2. doi: 10.1016/j.jpeds.2014.05.038. Epub 2014 Jul 9.
Related Links
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Childhood Liver Disease Research Network (ChiLDReN) website
Other Identifiers
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BASIC Study - ChiLDReN Network
Identifier Type: -
Identifier Source: org_study_id
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