We propose to develop and maintain a Data Coordinating Center (DCC) that will provide support for a network of clinical sites studying chronic pediatric liver disease. Specifically we will continue, expand, and merge the efforts of investigators from the Biliary Atresia Research Consortium (BARC) and the Cholestatic Liver Disease Consortium (CLiC) to form the Childhood Liver Disease Research Education Network (ChiLDREN).
The specific aims of the ChiLDREN DCC are to: 1. Integrate the data from all of the BARC and CLiC studies. 2. Continue to coordinate and refine the ongoing studies in these networks, providing assistance as necessary and monitoring sites for data quality. 3. Provide expertise in the design, conduct, and analysis of studies to be performed by the network. 4. Develop plans for data analysis, perform the analysis, and collaborate in the preparation of the presentations and publications that will arise from these studies. 5. Maintain the database for specimen tracking to coordinate with the NIDDK repositories. 6. Develop effective administrative systems to provide timely consultation, review, and assistance with implementation for ancillary studies approved by the ChiLDREN Steering Committee. 7. Coordinate the efforts of the ChiLDREN Steering Committee and all ChiLDREN committees and working groups by providing leadership and logistic support. 8. Develop and modify the Data Safety and Monitoring Plan for ChiLDREN, and facilitate the work of the Data Safety Monitoring Board, by monitoring and reporting adverse events as well as providing regular progress reports. 9. Develop and maintain an effective ChiLDREN website that serves as a resource to patients and their families, as well as ChiLDREN investigators and coordinators. Relevance: Chronic pediatric liver disease is a devastating condition that has profound impact on children, their families, and our society. Biliary atresia, along with the other cholestatic liver diseases studied by the Network, account for over half of liver transplants performed in children in the United States. A better understanding of the diseases studied by this Network will help provide better care of patients with chronic liver disease.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK062456-12S1
Application #
8705198
Study Section
Special Emphasis Panel (ZDK1-GRB-S (M1))
Program Officer
Sherker, Averell H
Project Start
2002-09-18
Project End
2014-05-31
Budget Start
2013-09-01
Budget End
2014-05-31
Support Year
12
Fiscal Year
2013
Total Cost
$150,000
Indirect Cost
$53,537
Name
University of Michigan Ann Arbor
Department
Surgery
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
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Ng, Vicky L; Sorensen, Lisa G; Alonso, Estella M et al. (2018) Neurodevelopmental Outcome of Young Children with Biliary Atresia and Native Liver: Results from the ChiLDReN Study. J Pediatr 196:139-147.e3
Shneider, Benjamin L; Spino, Cathie; Kamath, Binita M et al. (2018) Placebo-Controlled Randomized Trial of an Intestinal Bile Salt Transport Inhibitor for Pruritus in Alagille Syndrome. Hepatol Commun 2:1184-1198
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Ye, Wen; Narkewicz, Michael R; Leung, Daniel H et al. (2018) Variceal Hemorrhage and Adverse Liver Outcomes in Patients With Cystic Fibrosis Cirrhosis. J Pediatr Gastroenterol Nutr 66:122-127
Wang, Kasper S; Tiao, Greg; Bass, Lee M et al. (2017) Analysis of surgical interruption of the enterohepatic circulation as a treatment for pediatric cholestasis. Hepatology 65:1645-1654
Shneider, Benjamin L; Moore, Jeff; Kerkar, Nanda et al. (2017) Initial assessment of the infant with neonatal cholestasis-Is this biliary atresia? PLoS One 12:e0176275
Shneider, Benjamin L; Magee, John C; Karpen, Saul J et al. (2016) Total Serum Bilirubin within 3 Months of Hepatoportoenterostomy Predicts Short-Term Outcomes in Biliary Atresia. J Pediatr 170:211-7.e1-2
Tsai, Ellen A; Gilbert, Melissa A; Grochowski, Christopher M et al. (2016) THBS2 Is a Candidate Modifier of Liver Disease Severity in Alagille Syndrome. Cell Mol Gastroenterol Hepatol 2:663-675.e2
Russo, Pierre; Magee, John C; Anders, Robert A et al. (2016) Key Histopathologic Features of Liver Biopsies That Distinguish Biliary Atresia From Other Causes of Infantile Cholestasis and Their Correlation With Outcome: A Multicenter Study. Am J Surg Pathol 40:1601-1615

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