Thymalin
Thymulin, Thymic Factor, Serum Thymic Factor, Facteur Thymique Serique
Recruiting
OBSERVATIONAL
NCT05399745
BILACO Trial: Biliary Atresia - a Severe Complex Congenital Liver Disease
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Biliary atresia is the most severe form of cholestatic liver disease. The children have high morbidity and mortality and get devastating pruritus and fatigue, failure to thrive, progressive hepatic failure and impaired neurodevelopment. The etiology is mostly unknown. More than half need a new liver from a living or deceased donor during childhood. However, correct timing of the transplantation is extremely difficult because of lack of consensus based on clinical assessment tools. All though the incidence is low, the cost of this disease is tremendous from both a clinical and human perspective. So far, protocolized neurodevelopment tests, genetic profiling, precise malnutrition evaluation based on clinical appearance, biochemical markers and brain MRI-scans, body composition, immunological function, level of physical activity and optimal time of transplantation in cholestatic children are unknown. The aim is to determine risk factors for neurocognitive impairment in children suffering from severe cholestasis in order to determine optimal time for liver transplantation from a brain perspective. In a prospective study, the investigators will investigate risk factors related to brain-, heart-, gut- and immunological function in the Danish cohort. This cohort consists of 75 children aged 0-18 years. In addition, 30 aged and gender matched healthy and 20 tetra fallot children will serve as control groups. The children will undergo extensive and advanced liver function evaluation, genetic profiling, nutrition and immunological status, neuro-imaging and neurocognitive evaluation at time of diagnose, 2 years of age, pre-school, pre-teenage, and teenage. In case of a liver transplantation, additional neuro-cognitive tests will be performed
Interventions
Name:
Neurocognitive monitoring
Type:
OTHER
Description:
Neurocognitive tests and MRI of the brain
Primary Outcomes
Measure:
MRI of the brain
TimeFrame:
Inclusion
Description:
% of patients with anatomic anomalies on MRI of the brain
Measure:
Neurocognitive status: Early movement repertoire (General movement)
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion
% of patients with of abnormal movement assessed using early movement repertoire (GM) if inclusion at diagnosis. Early movement repertoire is a measurement tool where abnormal movement is identified.
Measure:
Neurocognitive status: Alberta Infant Motor Scale
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
Alberta Infant Motor Scale if inclusion at diagnosis
Percentile, highest is the best
Measure:
Neurocognitive status: Bayley Scales of Development III
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
Bayley Scales of Development III if inclusion up to 2.5 years:
From 0-200, highest is best
Measure:
Neurocognitive status: WIPPSI
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
WIPPSI if inclusion between 2.5-6 years:
Wechsler Preschool and Primary Scale of Intelligence, from 41 to 160, highest is best
Measure:
Neurocognitive status: ABC Movement
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
ABC Movement if inclusion between 2.5-16 years
Movement Assessment Battery for Children, mean 10 SD 3, highest is best
Measure:
Neurocognitive status: WISC-IV
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
WISC-IV if inclusion between 6-16 years
Wechsler Intelligence Scale for Children, 40 to 160, highest is best
Measure:
Neurocognitive status: Auditory Verbal Learning Test/ToMaL
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
Auditory Verbal Learning Test/ToMaL if inclusion between 6-18 years Mean 10 SD 3, highest is best
Measure:
Neurocognitive status: TEA-Ch
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
TEA-Ch if inclusion between 6-18 years
Test of Everyday Attention for Children, normalized to z-score, highest is best
Measure:
Neurocognitive status: BADS-C
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
BADS-C if inclusion between 6-18 years Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best
Measure:
Neurocognitive status: Test of Visual Perceptual Skills
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
Test of Visual Perceptual Skills if inclusion between 6-18 years
Percentile, highest is best
Measure:
Neurocognitive status: CANTAB
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
CANTAB if inclusion between 6-18 years Cambridge Neuropsychological Test Automated Battery
Measure:
Neurocognitive status: The Beery Visuo-Motor Integration test
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
The Beery Visuo-Motor Integration test if inclusion between 6-18 years Mean of 100 and standard deviation of 15, highest is best
Measure:
Neurocognitive status: WAIS IV
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
WAIS IV if inclusion from 16 to 18 years Wechsler Adult Intelligence Scale, 40-160, highest is best
Measure:
Neurocognitive status: Kiddie-sads
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
Kiddie-sads if included between 2-18 years Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best
Measure:
Neurocognitive status: BRIEF 1
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
BRIEF 1 if inclusion up to 6 years Behaviour Rating Inventory of Executive Function, percentile, lowest is best
Measure:
Neurocognitive status: BRIEF 2
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
BRIEF 2 if inclusion between 6-18 years Behaviour Rating Inventory of Executive Function, percentile, lowest is best
Measure:
Neurocognitive status: CBCL
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
CBCL if included between 2-18 years Child Behavior Checklist, percentile, lowest is best
Measure:
Neurocognitive status: ADHD screening
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
ADHD screening if included between 2-18 years Lowest is best, 0-78
Measure:
Neurocognitive status: SRS-2
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
SRS-2 screening if included between 6-18 years
Social Responsiveness Scale, 32-114. lowest is best
Measure:
Neurocognitive status: Vineland
TimeFrame:
Inclusion
Description:
Neurocognitive test panel depending on age at inclusion:
Vineland screening if included between 6-18 years Vineland Adaptive Behavior Scales, 20 to 160, highest is best
Measure:
MRI of the brain
TimeFrame:
1 year
Description:
% of patients with anatomic anomalies on MRI of the brain
Measure:
Neurocognitive status: Alberta Infant Motor Scale
TimeFrame:
1 year
Description:
Alberta Infant Motor Scale Percentile, highest is the best
Measure:
Neurocognitive status: Bayley Scales of Development III
TimeFrame:
1 year
Description:
Bayley Scales of Development III
From 0-200, highest is best
Measure:
Neurocognitive status: BRIEF 1
TimeFrame:
1 year
Description:
BRIEF 1 Behaviour Rating Inventory of Executive Function, percentile, lowest is best
Measure:
Neurocognitive status: CBCL
TimeFrame:
1 year
Description:
CBCL Child Behavior Checklist, percentile, lowest is best
Measure:
Neurocognitive status: Kiddie-Sads
TimeFrame:
1 year
Description:
Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best
Measure:
MRI of the brain
TimeFrame:
2 years
Description:
% of patients with anatomic anomalies on MRI of the brain
Measure:
Neurocognitive status: Bayley Scales of Development III
TimeFrame:
2 years
Description:
Bayley Scales of Development III From 0-200, highest is best
Measure:
Neurocognitive status: BRIEF 1
TimeFrame:
2 years
Description:
BRIEF 1 Behaviour Rating Inventory of Executive Function, percentile, lowest is best
Measure:
Neurocognitive status: CBCL
TimeFrame:
2 years
Description:
CBCL Child Behavior Checklist, percentile, lowest is best
Measure:
Neurocognitive status: Kiddie-Sads
TimeFrame:
2 years
Description:
Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best
Measure:
Neurocognitive status: ADHD
TimeFrame:
2 years
Description:
ADHD Lowest is best, 0-78
Measure:
Neurocognitive status: Vineland
TimeFrame:
2 years
Description:
Vineland Adaptive Behavior Scales, 20 to 160, highest is best
Measure:
MRI of the brain
TimeFrame:
6 years
Description:
% of patients with anatomic anomalies on MRI of the brain
Measure:
Neurocognitive: Movement ABC
TimeFrame:
6 years
Description:
Neurocognitive test panel depending on age Movement Assessment Battery for Children, mean 10 SD 3, highest is best
Measure:
Neurocognitive status: WISC-IV
TimeFrame:
6 years
Description:
WISC-IV
Wechsler Intelligence Scale for Children, 40 to 160, highest is best
Measure:
Neurocognitive status: Auditory Verbal Learning Test/ToMaL
TimeFrame:
6 years
Description:
Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best
Measure:
Neurocognitive status: TEA-Ch
TimeFrame:
6 years
Description:
TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best
Measure:
Neurocognitive status: BADS-C
TimeFrame:
6 years
Description:
BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best
Measure:
Neurocognitive status: Test of Visual Perceptual Skills
TimeFrame:
6 years
Description:
Test of Visual Perceptual Skills Percentile, highest is best
Measure:
Neurocognitive status: The Beery Visuo-Motor Integration test
TimeFrame:
6 years
Description:
The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best
Measure:
Neurocognitive status: CANTAB
TimeFrame:
6 years
Description:
CANTAB Cambridge Neuropsychological Test Automated Battery
Measure:
Neurocognitive status: BRIEF 2
TimeFrame:
6 years
Description:
BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best
Measure:
Neurocognitive status: ADHD screening
TimeFrame:
6 years
Description:
ADHD screening Lowest is best, 0-78
Measure:
Neurocognitive status: SRS-2
TimeFrame:
6 years
Description:
SRS-2 Social Responsiveness Scale, 32-114. lowest is best
Measure:
Neurocognitive status: Kiddie-Sads
TimeFrame:
6 years
Description:
Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best
Measure:
Neurocognitive status: CBCL
TimeFrame:
6 years
Description:
CBCL Child Behavior Checklist, percentile, lowest is best
Measure:
Neurocognitive status: Vineland
TimeFrame:
6 years
Description:
Vineland Vineland Adaptive Behavior Scales, 20 to 160, highest is best
Measure:
MRI of the brain
TimeFrame:
11 years
Description:
% of patients with anatomic anomalies on MRI of the brain
Measure:
Neurocognitive status: Movement ABC
TimeFrame:
11 years
Description:
Neurocognitive test panel depending on age at inclusion:
ABC Movement if inclusion between 2.5-16 years
Movement Assessment Battery for Children, mean 10 SD 3, highest is best
Measure:
Neurocognitive status: WISC-IV
TimeFrame:
11 years
Description:
WISC-IV
Wechsler Intelligence Scale for Children, 40 to 160, highest is best
Measure:
Neurocognitive status: Auditory Verbal Learning Test/ToMaL
TimeFrame:
11 years
Description:
Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best
Measure:
Neurocognitive status:TEA-Ch
TimeFrame:
11 years
Description:
TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best
Measure:
Neurocognitive status: BADS-C
TimeFrame:
11 years
Description:
BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best
Measure:
Neurocognitive status: Test of Visual Perceptual Skills
TimeFrame:
11 years
Description:
Test of Visual Perceptual Skills Percentile, highest is best
Measure:
Neurocognitive status: The Beery Visuo-Motor Integration test
TimeFrame:
11 years
Description:
The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best
Measure:
Neurocognitive status: CANTAB
TimeFrame:
11 years
Description:
CANTAB Cambridge Neuropsychological Test Automated Battery
Measure:
Neurocognitive status: BRIEF 2
TimeFrame:
11 years
Description:
BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best
Measure:
Neurocognitive status: ADHD screening
TimeFrame:
11 years
Description:
ADHD screening Lowest is best, 0-78
Measure:
Neurocognitive status: SRS-2
TimeFrame:
11 years
Description:
SRS-2 Social Responsiveness Scale, 32-114. lowest is best
Measure:
Neurocognitive status: Kiddie-Sads
TimeFrame:
11 years
Description:
Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best
Measure:
Neurocognitive status: CBCL
TimeFrame:
11 years
Description:
CBCL Child Behavior Checklist, percentile, lowest is best
Measure:
Neurocognitive status: Vineland
TimeFrame:
11 years
Description:
Vineland Adaptive Behavior Scales, 20 to 160, highest is best
Measure:
MRI of the brain
TimeFrame:
16 years
Description:
% of patients with anatomic anomalies on MRI of the brain
Measure:
Neurocognitive status: Movement ABC
TimeFrame:
16 years
Description:
Neurocognitive test panel depending on age at inclusion:
ABC Movement if inclusion between 2.5-16 years
Movement Assessment Battery for Children, mean 10 SD 3, highest is best
Measure:
Neurocognitive status: WISC-IV
TimeFrame:
16 years
Description:
WISC-IV Wechsler Adult Intelligence Scale, 40-160, highest is best
Measure:
Neurocognitive status: Auditory Verbal Learning Test/ToMaL
TimeFrame:
16 years
Description:
Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best
Measure:
Neurocognitive status: TEA-Ch
TimeFrame:
16 years
Description:
TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best
Measure:
Neurocognitive status: BADS-C
TimeFrame:
16 years
Description:
BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best
Measure:
Neurocognitive status: Test of Visual Perceptual Skills
TimeFrame:
16 years
Description:
Test of Visual Perceptual Skills Percentile, highest is best
Measure:
Neurocognitive status: The Beery Visuo-Motor Integration test
TimeFrame:
16 years
Description:
The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best
Measure:
Neurocognitive status: CANTAB
TimeFrame:
16 years
Description:
CANTAB Cambridge Neuropsychological Test Automated Battery
Measure:
Neurocognitive status: BRIEF 2
TimeFrame:
16 years
Description:
BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best
Measure:
Neurocognitive status: ADHD screening
TimeFrame:
16 years
Description:
ADHD screening Lowest is best, 0-78
Measure:
Neurocognitive status: SRS-2
TimeFrame:
16 years
Description:
SRS-2 Social Responsiveness Scale, 32-114. lowest is best
Measure:
Neurocognitive status: Kiddie-Sads
TimeFrame:
16 years
Description:
Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best
Measure:
Neurocognitive status: CBCL
TimeFrame:
16 years
Description:
CBCL Child Behavior Checklist, percentile, lowest is best
Measure:
Neurocognitive status: Vineland
TimeFrame:
16 years
Description:
Vineland Adaptive Behavior Scales, 20 to 160, highest is best
Trial Information
NCT ID
NCT05399745
Status
Recruiting
Study Type
OBSERVATIONAL
Sponsor
Rigshospitalet, Denmark
Last Updated
December 15, 2025