A Prospective Database of Infants With Cholestasis
Age: Birth - 6 months
Healthy Subjects: No
Recruitment Status: Recruiting
Start Date: May 01, 2004
End Date: May 01, 2024
- 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. 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).