Database of infants with cholestasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to create a comprehensive database of clinical information and biological samples from infants diagnosed with cholestatic liver diseases, including biliary atresia and idiopathic neonatal hepatitis. The study will enroll infants at participating pediatric liver centers and follow them closely for the first year, with annual follow-ups until they reach 20 years of age or undergo liver transplantation. The collected data and samples will support research into the causes and treatments of these liver conditions, enhancing understanding and management of pediatric liver diseases.

Why it matters

Who can join: the full rules

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).

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Children's Healthcare of Atlanta - Emory University
  Atlanta, Georgia, United States Recruiting
• Ann & Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: John Magee, MD — University of Michigan Medical Center, Ann Arbor
• Study coordinator: Melissa Sexton, BBA, CCRP
• Email: melissa.sexton@arborresearch.org
• Phone: 734-693-3811

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Umbilical cord stem cells added during Kasai to help biliary atresia

  This early-stage trial tests whether injecting umbilical cord mesenchymal stem cells during Kasai portoenterostomy is safe and helpful for infants with biliary atresia.

  Recruiting Phase 1 Dr Cipto Mangunkusumo General Hospital · Jakarta Pusat, DKI Jakarta · NCT07797673

• See if a computer program can help diagnose cholestasis in newborns using parent-provided stool images

  A computer program is being tested to see if it can correctly identify cholestasis and biliary atresia in newborns by analyzing stool images provided by parents.

  Recruiting Birmingham Women's and Children's NHS Foundation Trust · Birmingham · NCT07697872

• Indocyanine green for diagnosing biliary atresia

  This test tries to see if a harmless fluorescent dye (indocyanine green) can show whether infants under 3 months with cholestasis have blocked bile ducts (biliary atresia).

  Recruiting Phase 1/2 Boston Children's Hospital · Boston, Massachusetts · NCT07513038

• Using near-infrared ICG dye to check bile flow in newborns with cholestasis

  We will give eligible newborns a single IV dose of indocyanine green (ICG) to see if the dye appears in their diapers, which would indicate bile is flowing and the bile ducts are open.

  Recruiting Early Phase 1 University of Alabama at Birmingham · Birmingham, Alabama · NCT07250854

• High-MCT nutritional support for infants with biliary atresia

  We will test whether giving a high medium-chain triglyceride (MCT) formula before and after Kasai surgery helps infants with biliary atresia grow better and recover faster than standard feeding.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT06764082

• Using oral antibiotics to prevent cholangitis after liver surgery in infants

  This study is testing if giving oral antibiotics to infants after liver surgery can help prevent cholangitis, compared to those who don’t receive the antibiotics.

  Recruiting Children's Hospital of Fudan University · Shanghai, Shanghai Municipality · NCT05925309

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.