Observing cognitive impairment in children with biliary atresia
BILACO Trial: Biliary Atresia - a Severe Complex Congenital Liver Disease With High Mortality, Compromised Neurological Development, Severe Malnutrition and Unknown Etiology
Rigshospitalet, Denmark · NCT05399745
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 type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05399745 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study include children diagnosed with biliary atresia, those with tetralogy of Fallot, and healthy controls for comparison.
Not a fit: Patients who are unable to participate in examinations or assessments will not benefit from this study.
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 performed: While biliary atresia is a well-known condition, this specific approach to assessing neurocognitive impairment through comprehensive monitoring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biliary atresia * Tetralogy of Fallot * Healthy controls Exclusion Criteria: \- Not able to participate in exams
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
Study contacts
- Principal investigator: Vibeke Brix Christensen, MD, PhD, DMSc — Rigshospitalet, Denmark
- Study coordinator: Vibeke Brix Christensen, MD, PhD, DMSc
- Email: vibeke.brix.christensen@regionh.dk
- Phone: +4535458842
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.
Conditions: Biliary Atresia, Cognitive Impairment