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A Prospective Database of Infants With Cholestasis

RecruitingObservational study

Childhood Liver Disease Research Network (ChiLDReN): A Prospective Database of Infants With Cholestasis

Who can join

6 Months · All sexes

Full 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) 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).

About the study

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.

Sponsor: Arbor Research Collaborative for Health · Participants: 1,000 · Started: Apr 21, 2004

Contact the study team

Official record on ClinicalTrials.gov — NCT00061828

Locations in the U.S.

CaliforniaChildren's Hospital Los Angeles, Los Angeles
ColoradoChildren's Hospital Colorado, Aurora
GeorgiaChildren's Healthcare of Atlanta - Emory University, Atlanta
IllinoisAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago
OhioCincinnati Children's Hospital Medical Center, Cincinnati
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
TexasBaylor College of Medicine, Houston
UtahUniversity of Utah, Salt Lake City
WashingtonSeattle Children's Hospital, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.