A Prospective Database of Infants With Cholestasis (PROBE)
Number of Subjects in Study Archive: 1000+
Study Design: Observational
Conditions: Biliary Atresia, Cholestasis
Duration: May 2004 -
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Access to samples for A Prospective Database of Infants With Cholestasis (PROBE) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT00061828
This is a multi-center project to establish a prospective database of clinical information and a repository of blood and tissue samples from children with diagnoses of neonatal liver diseases, such as biliary atresia and neonatal hepatitis, in order to perform research in these liver problems. Children were screened and enrolled at presentation at the participating pediatric liver sites. Subjects diagnosed with biliary atresia were followed intensively for the first year, at 18 months of age, and then annually up to 15 years of age. Other subjects diagnosed with cholestasis were followed on the same schedule; if there was complete (clinical and biochemical) resolution of their underlying liver disease off all therapy, there was one follow up visit within one year (preferably scheduled at the time of the next planned follow up visit or at 12 months of age, whichever was later) for data collection and to obtain blood samples. The development of a serum and tissue bank of specimens from children with various neonatal cholestatic disorders are used for future investigations into the etiology and pathogenesis of hepatobiliary injury in the infant.
Two analysis datasets as described in the DSIC documents are now available.
Establish a database of clinical information and collect samples of blood, DNA, urine and liver tissue for research purposes.
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 20% of total and greater than or equal to 2 mg/dl.
The subject's parent(s)/guardian(s) willing to provide informed written consent.
- See the Clinical Trials URL above for a complete list of exclusion Criteria
This study is ongoing.