A Prospective Database of Infants With Cholestasis
ConditionBiliary Atresia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 6
SponsorArbor Research Collaborative for Health
About this trial
Biliary atresia, idiopathic neonatal hepatitis, and specific genetic cholestatic conditions are the most common causes of jaundice and hyperbilirubinemia that continue beyond the newborn period. The long term goal of the Childhood Liver Disease Research Network (ChiLDReN) is to establish a database of clinical information and plasma, serum, and tissue samples from cholestatic children to facilitate research and to perform clinical, epidemiological and therapeutic trials in these important pediatric liver diseases.
Eligibility criteria
Qualifiers
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 or equal to 2 mg/dl and suspected biliary atresia.
The subject's parent(s)/guardian(s) willing to provide informed written consent.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupLocations
16Canada
The Hospital for Sick ChildrenM5G 1X8, TorontoOntario, Canada
United States
California
Children's Hospital Los Angeles90027, Los Angeles United States
University of California94143, San Francisco United States
Colorado
Children's Hospital Colorado80045, Aurora United States
Sponsors and collaborators
Arbor Research Collaborative for Health
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov