A Prospective Database of Infants With Cholestasis
Recruiting
Observational Study
Biliary Atresia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
Up to 6 Months
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
Arbor Research Collaborative for Health · Other
Who this trial is looking for
This trial is looking for infants with cholestasis, a condition affecting the liver. Participating involves providing clinical information and samples for research on liver diseases in children.
Are You a Good Fit for This Trial?
You may be able to join if
I am an infant less than 180 days old.
I have been diagnosed with cholestasis with bilirubin levels of 2 mg/dl or higher.
My parent or guardian is willing to give written consent.
You may not be able to join if
I have acute liver failure.
I have had any liver surgery that involved cutting or removing liver tissue.
I was diagnosed with sepsis unless I also have liver disease.
I had hypoxia, shock, or ischemic liver problems in the last two weeks.
I have any type of cancer.
I have a primary hemolytic disease unless I also have biliary atresia.
I have drug or nutrition-related cholestasis unless I also have biliary atresia.
I have cholestasis related to ECMO treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 facilitat…
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.
Trial Locations
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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 or equal to 2 mg/dl and suspected biliary atresia.
* The subject's parent(s)/guardian(s) wi…
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 or equal to 2 mg/dl and suspected biliary atresia.
* 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).
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