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 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

Locations (15)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Sirikorn Boonsawat
323-361-2181
Rohit Kohli, MD (PRINCIPAL_INVESTIGATOR)
Christopher Gayer, MD (SUB_INVESTIGATOR)
University of CaliforniaSan FranciscoCalifornia94143-
Children's Hospital ColoradoAuroraColorado80045
Cynthia Castanon
720-777-0587
Michelle Landis
720-777-8884
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 UniversityAtlantaGeorgia30322
Katelynn Harris
404-785-0421
Jordyn Turner
404-785-3690
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 ChicagoChicagoIllinois60614
Jacqueline Alexander
312-227-3523
Angela Anthony
312-227-4559
Estella Alonso, MD (PRINCIPAL_INVESTIGATOR)
Lee Bass, MD (SUB_INVESTIGATOR)
Riley Hospital for ChildrenIndianapolisIndiana46202-
Johns Hopkins School of MedicineBaltimoreMaryland21287-
Washington University School of MedicineSt LouisMissouri63110-
Mount Sinai Medical CenterNew YorkNew York10029-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Jennifer Hawkins, MS
513-636-7818
Erin Chapman, BAS
513-803-7482
Alexander Miethke, MD (PRINCIPAL_INVESTIGATOR)
Joseph Palermo, MD (SUB_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Caitlin Griffiths
267-577-9888
Jordan Moreno
267-425-1614
Kathleen Loomes, MD (PRINCIPAL_INVESTIGATOR)
Elizabeth Rand, MD (SUB_INVESTIGATOR)
David Piccoli, MD (SUB_INVESTIGATOR)
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224-
Baylor College of MedicineHoustonTexas77030
Laurel Cavallo
832-822-1053
Cynthia Tsai, MPH
832-822-3634
Paula Hertel, MD (PRINCIPAL_INVESTIGATOR)
Benjamin Shneider, MD (SUB_INVESTIGATOR)
University of UtahSalt Lake CityUtah84113
Ann Rutherford
801-585-9495
Natalie Fillerup
801-587-5670
Stephen Guthery, MD (PRINCIPAL_INVESTIGATOR)
Kyle Jensen, MD (SUB_INVESTIGATOR)
Linda Book, MD (SUB_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Melissa Young
206-987-1037
Teresa Chen
206-987-6649
Evelyn Hsu, MD (SUB_INVESTIGATOR)
Niviann Blondet, MD (SUB_INVESTIGATOR)
Pamela Valentino, MD (PRINCIPAL_INVESTIGATOR)

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