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
This trial does not accept healthy volunteersQualifiers
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 population
This study population will be selected from the patient base of participating specialty care clinics.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Biliary Atresia
Trial outcomes
Primary outcomes
1
Change in disease severity over time (disease progression)
disease progression defined by transplant date, date of death, worsening liver function, and complications related to worsening liver function
Time frame
Measured at baseline, 1 month, 2 months, 3, 6 months post-baseline, 12 and 18 months of age, annually through year 10 and then biannually through year 20.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Arbor Research Collaborative for Health
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov