Research

Infant Cholestasis Database

A Prospective Database of Infants With Cholestasis

Protocol Description

The purpose of this research is to establish a prospective national database with demographic and clinical information about infants with cholestatic disease and their families. The database will provide a means of prospectively following these children over time to characterize the natural history of the disease, and to identify environmental, infectious and genetic risk factors related to onset, to outcome and treatment success for the different cholestatic diseases, with special emphasis on biliary atresia. Another aim of the study is to establish repositories for blood, urine, bile and tissue samples from these children and blood samples from their biological parents for future research studies on liver diseases.

This study is being conducted through the Childhood Liver Disease Research and Education Network (ChiLDREN), a network of 15 clinical sites in the United States and Canada.

Eligibility Criteria

Infants no older than 6 months, with a diagnosis of clinically meaningful cholestasis due to primary hepatobiliary disease.
Boys: Newborn through 180 days
Girls: Newborn through 180 days

Requirements
Participants will make a series of visits for physical examinations that will include collection of blood and urine samples, as would normally be done through routine clinic visits for patients with cholestasis. Visits generally are scheduled at 1, 2, 3 and 6 months following diagnosis and at 12, 18 and 24 months of age, and then annually until age 10. The parents or guardians of participants will be asked to maintain a journal of the patient’s medical visits and any new medications or changes in medications prescribed for the patient.
Visits: 15
Duration: 10 years

Status: Open for Enrollment

Source of Support
National Institutes of Health

Additonal Resources
Study summary at National Institutes of Health
Biliary Atresia