Biliary AtresiaBARNNNCT06184971
Biliary Atresia Research Network Northeast
An observational study of Biliary Atresia, run by Yale University at 14 sites in United States.
Trial summary
This is a multi-center retrospective chart review to compile a data repository of the management and outcomes of children with biliary atresia. Overall, investigators aim to evaluate which specific factors contribute to improved patient outcomes, to help guide potential improvements in patient care and resource… Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Biliary Atresia
- How many people
- 320 participants
- Where
- 14 sitesUnited States
- Study dates
- 6 May 2024to 27 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 12 years and younger (at the time of the qualifying encounter for care) who were diagnosed with biliary atresia, underwent surgical intervention for biliary atresia, and/or had an encounter for care related to biliary atresia at a participating institution during the study period. Patients who did not undergo surgery will be included (e.g. patients who died before surgery).
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Albany Medical Center/Bernard & Millie Duke's Children's Hospital
Albany, New York, 12208
Eastern Maine Medical Center
Bangor, Maine, 04401
Massachusetts General Hospital for Children
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
John R. Oishei Children's Hospital
Buffalo, New York, 14203
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Yale University
New Haven, Connecticut, 06510
Maine Medical Center
Portland, Maine, 04102
Rhode Island Hospital/Hasbro Children's Hospital
Providence, Rhode Island, 02905
University of Rochester Medical Center/Golisano Children's Hospital
Rochester, New York, 14642
Baystate
Springfield, Massachusetts, 01199
SUNY Upstate Medical University
Syracuse, New York, 13210
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
About this study
Official title: Biliary Atresia Research Network Northeast (BARNN)
This is a multi-center retrospective chart review to compile a data repository of the management and outcomes of children with biliary atresia. Overall, investigators aim to evaluate which specific factors contribute to improved patient outcomes, to help guide potential improvements in patient care and resource utilization.
Read the detailed description
Biliary atresia is quite rare, with only 0.73 cases per 10,000 births in the US. Due to this rarity and the geographical spread of the US, the small number of cases end up being dispersed amongst the various pediatric hospitals, which leads to certain hospitals only encountering an affected patient once per decade. This rarity and dispersion makes biliary atresia difficult for researchers to study: single-institution studies are limited by low power and only provide narrow snapshots, whereas large NIH-sponsored consortia report highly selected outcomes from only the largest or most dedicated centers and have largely excluded New England. This leaves a significant knowledge gap regarding the management and outcomes at more typical hospitals. The purpose of this study is to collect clinical data from all children with biliary atresia at all hospitals providing pediatric surgical care in the Northeast, even very-low-volume hospitals. This is a retrospective study, only involving chart review. There will be no interaction with subjects, intervention, or collection of specimens for the purposes of this study. The data will only include clinical information that was recorded during the normal course of patient care. The subjects will be de-identified before entry into a HIPAA-compliant data repository. This data repository will allow researchers to pool data, to yield adequate statistical power and assess differences in management and outcomes regarding this very rare condition.
- Conditions
- Biliary Atresia
- Medical subject headings
- Biliary Atresia
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Patient death
Measured: 10 years
Kasai procedure
Need for biliary diversion procedure, including the Kasai portoenterostomy
Measured: 10 years
Liver transplant
Need for liver transplant
Measured: 10 years
Secondary outcomes (6)
Clearance of jaundice
Normalization of serum bilirubin after Kasai procedure
Measured: 6 months
Bilirubin level
Serum bilirubin level
Measured: 10 years
Cholangitis
Clinical diagnosis of cholangitis
Measured: 10 years
Bleeding
Post-operative bleeding requiring transfusion or return to the OR
Measured: 10 years
Presentation to ED
Patient presentation to the ED for complication related to biliary atresia
Measured: 10 years
Age at follow-up with providers
Frequency and age at most recent follow-up with Pediatric Surgeon and/or Hepatologist
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start6 May 2024
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary AtresiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Cowles, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184971
- Sponsor's protocol ID
- 2000035645
- Other IDs
- 000
- Acronym
- BARNN
- Status last verified
- Jun 2026
- First submitted
- 13 Dec 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biliary Atresia Research Network Northeast (BARNN)
- ClinicalTrials.gov ID
- NCT06184971
- Acronym / sponsor ID
- BARNN / 2000035645
- Conditions
- Biliary Atresia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center retrospective chart review to compile a data repository of the management and outcomes of children with biliary atresia. Overall, investigators aim to evaluate which specific factors contribute to improved patient outcomes, to help guide potential improvements in patient care and resource utilization.
Detailed description
Biliary atresia is quite rare, with only 0.73 cases per 10,000 births in the US. Due to this rarity and the geographical spread of the US, the small number of cases end up being dispersed amongst the various pediatric hospitals, which leads to certain hospitals only encountering an affected patient once per decade. This rarity and dispersion makes biliary atresia difficult for researchers to study: single-institution studies are limited by low power and only provide narrow snapshots, whereas large NIH-sponsored consortia report highly selected outcomes from only the largest or most dedicated centers and have largely excluded New England. This leaves a significant knowledge gap regarding the management and outcomes at more typical hospitals. The purpose of this study is to collect clinical data from all children with biliary atresia at all hospitals providing pediatric surgical care in the Northeast, even very-low-volume hospitals. This is a retrospective study, only involving chart review. There will be no interaction with subjects, intervention, or collection of specimens for the purposes of this study. The data will only include clinical information that was recorded during the normal course of patient care. The subjects will be de-identified before entry into a HIPAA-compliant data repository. This data repository will allow researchers to pool data, to yield adequate statistical power and assess differences in management and outcomes regarding this very rare condition.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 12 years and younger (at the time of the qualifying encounter for care) who were diagnosed with biliary atresia, underwent surgical intervention for biliary atresia, and/or had an encounter for care related to biliary atresia at a participating institution during the study period. Patients who did not undergo surgery will be included (e.g. patients who died before surgery).
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: 10 years
Patient death
Kasai procedure
Time frame: 10 years
Need for biliary diversion procedure, including the Kasai portoenterostomy
Liver transplant
Time frame: 10 years
Need for liver transplant
6 secondary outcomes
Clearance of jaundice
Time frame: 6 months
Bilirubin level
Time frame: 10 years
Cholangitis
Time frame: 10 years
Bleeding
Time frame: 10 years
Presentation to ED
Time frame: 10 years
Age at follow-up with providers
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
Related trials for Biliary Atresia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
Biliary Atresia
Active, not recruiting
Molecular Characterization for Understanding Biliary Atresia
Biliary Atresia
Active, not recruitingPhase 3
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
RecruitingPhase 1
Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia
Biliary Atresia, Kasai Operation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Cowles, MD principal investigator
Yale University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia, run by Yale University at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.