A Prospective Database of Infants With Cholestasis

Launched by ARBOR RESEARCH COLLABORATIVE FOR HEALTH · Jun 5, 2003

Keywords

ClinConnect Summary

This clinical trial is focused on understanding cholestasis in infants, a condition that can cause jaundice or yellowing of the skin and eyes due to problems with the liver. The study aims to create a comprehensive database that includes medical information and samples from children with cholestasis, particularly those diagnosed with biliary atresia, neonatal hepatitis, and certain genetic liver diseases. This information will help researchers better understand these conditions and improve future treatments.

To be eligible to participate, infants must be less than 180 days old and have a specific level of bilirubin in their blood that indicates cholestasis. Parents or guardians will need to provide written consent for their child to join the study. Participants can expect to provide samples of blood and possibly other tissues, and their medical information will be closely monitored. This trial is an important step toward advancing knowledge and treatment options for children suffering from liver diseases.

Gender

ALL

Eligibility 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 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).