A Prospective Database of Infants With Cholestasis
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Arbor Research Collaborative for Health
- Study ID
- NCT00061828
- Status
- Recruiting
Conditions
- Biliary Atresia
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 6 Months
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Apr 21, 2004
- Status verified
- Jun 2026
- Primary completion
- May 31, 2029
- Completion
- May 31, 2029
Study Design
- Enrollment
- 1,000 participants (estimated)
Arms
- Arm: Biliary AtresiaInfants 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
- Melissa Sexton, BBA, CCRP734-693-3811
- Melissa Sexton, BBA734-693-3811
Locations (15)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | Rohit Kohli, MD (PRINCIPAL_INVESTIGATOR) Christopher Gayer, MD (SUB_INVESTIGATOR) |
| University of California | San Francisco | California | 94143 | - |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | Ronald Sokol, MD (PRINCIPAL_INVESTIGATOR) Shikha Sundaram, MD (SUB_INVESTIGATOR) Amy Feldman, MD (SUB_INVESTIGATOR) Dania Brigham, MD (SUB_INVESTIGATOR) Michael Narkewicz, MD (SUB_INVESTIGATOR) |
| Children's Healthcare of Atlanta - Emory University | Atlanta | Georgia | 30322 | Nitika Gupta, MD (PRINCIPAL_INVESTIGATOR) Saul Karpen, MD, PhD (SUB_INVESTIGATOR) Rene Romero, MD (SUB_INVESTIGATOR) Miriam Vos, MD MSPH (SUB_INVESTIGATOR) |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60614 | Estella Alonso, MD (PRINCIPAL_INVESTIGATOR) Lee Bass, MD (SUB_INVESTIGATOR) |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | - |
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21287 | - |
| Washington University School of Medicine | St Louis | Missouri | 63110 | - |
| Mount Sinai Medical Center | New York | New York | 10029 | - |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Alexander Miethke, MD (PRINCIPAL_INVESTIGATOR) Joseph Palermo, MD (SUB_INVESTIGATOR) |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Kathleen Loomes, MD (PRINCIPAL_INVESTIGATOR) Elizabeth Rand, MD (SUB_INVESTIGATOR) David Piccoli, MD (SUB_INVESTIGATOR) |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | - |
| Baylor College of Medicine | Houston | Texas | 77030 | Paula Hertel, MD (PRINCIPAL_INVESTIGATOR) Benjamin Shneider, MD (SUB_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84113 | Stephen Guthery, MD (PRINCIPAL_INVESTIGATOR) Kyle Jensen, MD (SUB_INVESTIGATOR) Linda Book, MD (SUB_INVESTIGATOR) |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Evelyn Hsu, MD (SUB_INVESTIGATOR) Niviann Blondet, MD (SUB_INVESTIGATOR) Pamela Valentino, MD (PRINCIPAL_INVESTIGATOR) |
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