Collecting data on biliary atresia in children from Northeast hospitals
Biliary Atresia Research Network Northeast (BARNN)
This study is collecting information from hospitals in the Northeast to see what helps young children with biliary atresia do better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | N/A to 12 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 14 sites (Hartford, Connecticut and 13 other locations) |
| Trial ID | NCT06184971 on ClinicalTrials.gov |
What this trial studies
This observational study involves a multi-center retrospective chart review aimed at compiling a comprehensive data repository of the management and outcomes of children diagnosed with biliary atresia across various pediatric hospitals in the Northeast. By gathering clinical data from hospitals, including those with low patient volumes, the study seeks to identify specific factors that contribute to improved patient outcomes. The data will be de-identified and stored in a HIPAA-compliant repository, allowing researchers to analyze differences in management and outcomes for this rare condition. The study covers cases from January 1, 2012, to December 31, 2021, focusing on children aged 12 years and younger.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 12 years and younger who have had a healthcare encounter related to biliary atresia at a participating institution during the specified study period.
Not a fit: Patients aged 13 years or older during the study period will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies and outcomes for children with biliary atresia.
How similar studies have performed: While studies on biliary atresia exist, this approach of pooling data from multiple low-volume hospitals is relatively novel and aims to fill a significant knowledge gap.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children with a healthcare encounter related to biliary atresia at a participating institution during the study period (January 1st, 2012 through December 31st, 2021) * Age 12 years and younger at the time of the qualifying encounter during the study period (encompassing patients born between January 2nd, 1999 through December 31st, 2021) * Diagnosis of biliary atresia, based on one of the following ICD-10 codes: * Q44.2 Atresia of bile ducts * Q44.3 Congenital stenosis and stricture of bile ducts * Q44.4 Disorders of the biliary tract with major complication or comorbidity * Q44.5 Other congenital malformations of the bile ducts * Q44.6 Disorders of the biliary tract without major complication or comorbidity Exclusion Criteria: * Patients aged 13 years old or older during the study period (i.e. those born before January 2nd, 1999) * Patients born and/or diagnosed with biliary atresia after the end of the study period (i.e. those born after December 31st, 2021) * No diagnosis of biliary atresia * History of biliary atresia without any episodes of care related to biliary atresia during the study period (e.g. a teenager with history of BA who underwent Kasai procedure as an infant and has no current issues related to their BA and is receiving care for an unrelated reason)
Where this trial is running
Hartford, Connecticut and 13 other locations
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- Eastern Maine Medical Center — Bangor, Maine, United States (Recruiting)
- Maine Medical Center — Portland, Maine, United States (Recruiting)
- Massachusetts General Hospital for Children — Boston, Massachusetts, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Baystate — Springfield, Massachusetts, United States (Recruiting)
- UMass Memorial Medical Center — Worcester, Massachusetts, United States (Recruiting)
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Not_yet_recruiting)
- Albany Medical Center/Bernard & Millie Duke's Children's Hospital — Albany, New York, United States (Not_yet_recruiting)
- John R. Oishei Children's Hospital — Buffalo, New York, United States (Recruiting)
- University of Rochester Medical Center/Golisano Children's Hospital — Rochester, New York, United States (Recruiting)
- SUNY Upstate Medical University — Syracuse, New York, United States (Recruiting)
- Rhode Island Hospital/Hasbro Children's Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Robert Cowles, MD — Yale University
- Study coordinator: Isabelle Curran
- Email: isabelle.curran@yale.edu
- Phone: 203-785-2701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.