Neonatal cholestasis in children with Alpha-1-AT deficiency is a risk for earlier severe liver disease with male predominance.
Jeffrey Teckman, Philip Rosenthal, Rosalinda V Ignacio...
https://pubmed.ncbi.nlm.nih.gov/38055647Actively Recruiting
Age: 0 - 6Months
All Genders
ID00061828
Childhood Liver Disease Research Network (ChiLDReN): A Prospective Database of Infants With Cholestasis
Led by Arbor Research Collaborative for Health · Updated on 2026-06-04
1000
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Arbor Research Collaborative for Health
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying infants with cholestasis, including conditions like biliary atresia and idiopathic neonatal hepatitis that cause prolonged jaundice and high bilirubin levels after the newborn period. The Childhood Liver Disease Research Network (ChiLDReN) aims to create a database of clinical information and biological samples from affected children to support research and clinical trials on these serious liver diseases in children. This project collects detailed clinical data, laboratory results, and biological samples such as blood and tissue from infants diagnosed or suspected to have biliary atresia or other neonatal liver diseases. Infants diagnosed with biliary atresia are followed closely during their first year, at 18 months, annually up to age 10, and then every two years, or until liver transplantation occurs. Infants with other cholestatic diagnoses exit the study after diagnosis is confirmed. Participants undergo routine clinical care and evaluations, with data entered into a secure national research database. Blood samples are collected during clinically indicated procedures when possible. Researchers measure disease progression over time at multiple intervals from baseline through 20 years of age. The study involves long-term follow-up of outcomes and data are securely stored and eventually transferred to a national data repository.
CONDITIONS
Brief Title
A Prospective Database of Infants With Cholestasis
Who Can Participate
Age: 0 - 6Months
All Genders
Eligibility Criteria
You may qualify if you...
- Infant's age less than or equal to 180 days at initial presentation
- Diagnosis of cholestasis with serum direct or conjugated bilirubin greater than or equal to 2 mg/dl
- Suspected biliary atresia
- Parent(s)/guardian(s) willing to provide informed written consent
You will not qualify if you...
- Acute liver failure
- Previous hepatobiliary surgery involving bile duct tissue
- Diagnosis of bacterial or fungal sepsis (except with metabolic liver disease)
- Hypoxia, shock, or ischemic hepatopathy within past two weeks (unless cholestasis persists beyond two weeks)
- Any malignancy diagnosis
- Presence of primary hemolytic disease (except with biliary atresia or cholestatic diseases studied)
- Drug or total parenteral nutrition-associated cholestasis (except with biliary atresia or studied cholestatic diseases)
- Extracorporeal membrane oxygenation-associated cholestasis
- Birth weight less than 1500g (except with biliary atresia)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Diagnostic Evaluation
Duration - Up to diagnosis determination
Participants undergo diagnostic assessments as part of the clinical standard of care to determine their diagnosis and disease severity.
Visits as part of routine clinical care
Long-term Monitoring
Duration - Up to 20 years
Participants diagnosed with biliary atresia are followed intensively for the first year, then at 18 months, annually up to 10 years, and biannually thereafter until liver transplantation or study end. Participants with other diagnoses exit the study at diagnosis determination.
Multiple visits: frequent in the first year, then at 18 months, annually up to year 10, then biannually
Trial Site Locations
Total: 16 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
University of California
San Francisco, California, United States, 94143
Completed
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Children's Healthcare of Atlanta - Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614
Actively Recruiting
6
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Completed
7
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Completed
8
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Completed
9
Mount Sinai Medical Center
New York, New York, United States, 10029
Completed
10
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
11
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Completed
13
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
14
University of Utah
Salt Lake City, Utah, United States, 84113
Actively Recruiting
15
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
16
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Completed
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Research Team
M
Melissa Sexton, BBA, CCRP
M
Melissa Sexton, BBA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Cytomegalovirus in biliary atresia is associated with increased pretransplant death, but not decreased native liver survival.
Sarah Kemme, Jennifer D Canniff, Amy G Feldman...
https://pubmed.ncbi.nlm.nih.gov/37471052Presentation and Outcomes of Infants With Idiopathic Cholestasis: A Multicenter Prospective Study.
Paula M Hertel, Kieran Hawthorne, Sehee Kim...
https://pubmed.ncbi.nlm.nih.gov/34310436Neurodevelopmental Outcome of Young Children with Biliary Atresia and Native Liver: Results from the ChiLDReN Study.
Vicky L Ng, Lisa G Sorensen, Estella M Alonso...
https://pubmed.ncbi.nlm.nih.gov/29519540Total Serum Bilirubin within 3 Months of Hepatoportoenterostomy Predicts Short-Term Outcomes in Biliary Atresia.
Benjamin L Shneider, John C Magee, Saul J Karpen...
https://pubmed.ncbi.nlm.nih.gov/26725209Factors Determining δ-Bilirubin Levels in Infants With Biliary Atresia.
Wen Ye, Philip Rosenthal, John C Magee...
https://pubmed.ncbi.nlm.nih.gov/25564820Gene expression signature for biliary atresia and a role for interleukin-8 in pathogenesis of experimental disease.
Kazuhiko Bessho, Reena Mourya, Pranavkumar Shivakumar...
https://pubmed.ncbi.nlm.nih.gov/24493287Portal hypertension in children and young adults with biliary atresia.
Benjamin L Shneider, Bob Abel, Barbara Haber...
https://pubmed.ncbi.nlm.nih.gov/22903006Circulating microRNA is a biomarker of biliary atresia.
Adam M Zahm, Nicholas J Hand, LaTasha A Boateng...
https://pubmed.ncbi.nlm.nih.gov/22732895