Database of infants with cholestasis
Childhood Liver Disease Research Network (ChiLDReN): A Prospective Database of Infants With Cholestasis
This study is creating a database of health information and samples from infants with liver diseases to help researchers learn more about these conditions and improve treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 6 Months |
| Sex | All |
| Sponsor | Arbor Research Collaborative for Health Academic / other |
| Locations | 16 sites (Los Angeles, California and 15 other locations) |
| Trial ID | NCT00061828 on ClinicalTrials.gov |
What this trial studies
This project aims to create a comprehensive database of clinical information and biological samples from infants diagnosed with cholestatic liver diseases, including biliary atresia and idiopathic neonatal hepatitis. The study will enroll infants at participating pediatric liver centers and follow them closely for the first year, with annual follow-ups until they reach 20 years of age or undergo liver transplantation. The collected data and samples will support research into the causes and treatments of these liver conditions, enhancing understanding and management of pediatric liver diseases.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 180 days or younger who have been diagnosed with cholestasis.
Not a fit: Patients with acute liver failure, previous hepatobiliary surgery, or certain other severe conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could lead to improved diagnosis and treatment options for infants suffering from cholestatic liver diseases.
How similar studies have performed: Other studies focusing on pediatric liver diseases have shown promise, indicating that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 or equal to 2 mg/dl and suspected biliary atresia. * 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 Total parenteral nutrition (TPN)-associated cholestasis (except when diagnosed with biliary atresia or another cholestatic disease being studied by ChiLDREN). * Diagnosis with Extracorporeal membrane oxygenation (ECMO)-associated cholestasis. * Birth weight less than 1500g (except when diagnosed with biliary atresia).
Where this trial is running
Los Angeles, California and 15 other locations
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
- University of California — San Francisco, California, United States (Completed)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Children's Healthcare of Atlanta - Emory University — Atlanta, Georgia, United States (Recruiting)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Riley Hospital for Children — Indianapolis, Indiana, United States (Completed)
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Completed)
- Washington University School of Medicine — St Louis, Missouri, United States (Completed)
- Mount Sinai Medical Center — New York, New York, United States (Completed)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
- The Hospital for Sick Children — Toronto, Ontario, Canada (Completed)
Study contacts
- Principal investigator: John Magee, MD — University of Michigan Medical Center, Ann Arbor
- Study coordinator: Terese A Howell, BS
- Email: terri.howell@arborresearch.org
- Phone: 734 476-5340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.