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Clinical trial Recruiting at 1 site Observational Ages 0 to 18

Observing cognitive impairment in children with biliary atresia

Official title: BILACO Trial: Biliary Atresia - a Severe Complex Congenital Liver Disease With High Mortality, Compromised Neurological Development, Severe Malnutrition and Unknown Etiology

Run by Copenhagen University Hospital, Rigshospitalet · NCT05399745 · Data updated 2026-11-12

This study looks at children with biliary atresia to see how their liver disease affects their thinking skills and what factors might contribute to any cognitive problems they have.

Quick facts

Study typeObservational
Ages0 Years to 18 Years
SexAll
Enrollment100 (estimated)
SponsorCopenhagen University Hospital, Rigshospitalet
Academic / other
Locations1 site (Copenhagen)
StatusRecruiting
StartedMarch 1, 2020
Main results expectedDecember 31, 2039
Study endsDecember 31, 2040
Registry record updatedJune 1, 2022
Trial IDNCT05399745 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study include children diagnosed with biliary atresia, those with tetralogy of Fallot, and healthy controls for comparison.

Probably not a fit

Patients who are unable to participate in examinations or assessments will not benefit from this study.

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

What this trial studies

This observational study focuses on children diagnosed with biliary atresia, a severe liver disease that can lead to significant cognitive impairment. The research aims to identify risk factors associated with neurocognitive deficits by utilizing various assessment tools, including neurodevelopment tests, genetic profiling, and brain MRI scans. The study will also evaluate malnutrition and physical activity levels to determine the optimal timing for liver transplantation. By gathering comprehensive data, the study seeks to improve understanding and management of this complex condition.

Why it matters

Potential benefit: If successful, this study could lead to better management strategies for biliary atresia, potentially improving cognitive outcomes for affected children.

How similar studies have gone: While biliary atresia is a well-known condition, this specific approach to assessing neurocognitive impairment through comprehensive monitoring is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Biliary atresia
* Tetralogy of Fallot
* Healthy controls

Exclusion Criteria:

\- Not able to participate in exams

Where it's running

  • Rigshospitalet
    Copenhagen, Denmark     Recruiting

Study contacts

  • Principal investigator: Vibeke Brix Christensen, MD, PhD, DMSc — Copenhagen University Hospital, Rigshospitalet
  • Study coordinator: Vibeke Brix Christensen, MD, PhD, DMSc
  • Email: vibeke.brix.christensen@regionh.dk
  • Phone: +4535458842

Similar studies

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

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.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.