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BILACO
Sponsor study identifier
observational
100
1 country
1
Study Start
March 1, 2020
Actual (reported)Primary Completion
December 31, 2039
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2020
Actual (reported)March 8, 2022
Actual (reported)June 1, 2022
Actual (reported)December 31, 2039
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
MRI of the brain
% of patients with anatomic anomalies on MRI of the brain
Inclusion
Neurocognitive status: Early movement repertoire (General movement)
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.
Inclusion
Neurocognitive status: Alberta Infant Motor Scale
Neurocognitive test panel depending on age at inclusion: Alberta Infant Motor Scale if inclusion at diagnosis Percentile, highest is the best
Inclusion
Neurocognitive status: Bayley Scales of Development III
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
Inclusion
Neurocognitive status: WIPPSI
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
Genetics: Whole genome sequencing of blood
Inclusion
Genetics: Whole genome sequencing of liver biopsy
Inclusion
Microbiome: Urine proteomics
Inclusion
Microbiome: Feces proteomics
Inclusion
Microbiome: Saliva proteomics
Inclusion
Neurocognitive tests and MRI of the brain
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Children with biliary atresia (BA), children with Tetralogy of Fallot (ToF) and healthy control children between the age of 0-17 years. The BA and ToF children were recruited from their respective outpatient clinics at Rigshospitalet, Denmark, which is the only centre treating these patients. Healthy controls were siblings to BA children, recruited from staffs children and friends or recruited from a general practitioners office in Nivaa, Denmark. The recruitment took place from March 2020 and is ongoing
Rigshospitalet
Copenhagen, 2100, Denmark
Vibeke Brix Christensen, MD, PhD, DMSc
Copenhagen University Hospital, Rigshospitalet
First Submitted
March 8, 2022
First Posted
June 1, 2022
Study Start
March 1, 2020
Actual (reported)Primary Completion
December 31, 2039
EstimatedInclusion
Neurocognitive status: ABC Movement
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
Inclusion
Neurocognitive status: WISC-IV
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
Inclusion
Neurocognitive status: Auditory Verbal Learning Test/ToMaL
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
Inclusion
Neurocognitive status: TEA-Ch
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
Inclusion
Neurocognitive status: BADS-C
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
Inclusion
Neurocognitive status: Test of Visual Perceptual Skills
Neurocognitive test panel depending on age at inclusion: Test of Visual Perceptual Skills if inclusion between 6-18 years Percentile, highest is best
Inclusion
Neurocognitive status: CANTAB
Neurocognitive test panel depending on age at inclusion: CANTAB if inclusion between 6-18 years Cambridge Neuropsychological Test Automated Battery
Inclusion
Neurocognitive status: The Beery Visuo-Motor Integration test
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
Inclusion
Neurocognitive status: WAIS IV
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
Inclusion
Neurocognitive status: Kiddie-sads
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
Inclusion
Neurocognitive status: BRIEF 1
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
Inclusion
Neurocognitive status: BRIEF 2
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
Inclusion
Neurocognitive status: CBCL
Neurocognitive test panel depending on age at inclusion: CBCL if included between 2-18 years Child Behavior Checklist, percentile, lowest is best
Inclusion
Neurocognitive status: ADHD screening
Neurocognitive test panel depending on age at inclusion: ADHD screening if included between 2-18 years Lowest is best, 0-78
Inclusion
Neurocognitive status: SRS-2
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
Inclusion
Neurocognitive status: Vineland
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
Inclusion
MRI of the brain
% of patients with anatomic anomalies on MRI of the brain
1 year
Neurocognitive status: Alberta Infant Motor Scale
Alberta Infant Motor Scale Percentile, highest is the best
1 year
Neurocognitive status: Bayley Scales of Development III
Bayley Scales of Development III From 0-200, highest is best
1 year
Neurocognitive status: BRIEF 1
BRIEF 1 Behaviour Rating Inventory of Executive Function, percentile, lowest is best
1 year
Neurocognitive status: CBCL
CBCL Child Behavior Checklist, percentile, lowest is best
1 year
Neurocognitive status: Kiddie-Sads
Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best
1 year
MRI of the brain
% of patients with anatomic anomalies on MRI of the brain
2 years
Neurocognitive status: Bayley Scales of Development III
Bayley Scales of Development III From 0-200, highest is best
2 years
Neurocognitive status: BRIEF 1
BRIEF 1 Behaviour Rating Inventory of Executive Function, percentile, lowest is best
2 years
Neurocognitive status: CBCL
CBCL Child Behavior Checklist, percentile, lowest is best
2 years
Neurocognitive status: Kiddie-Sads
Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best
2 years
Neurocognitive status: ADHD
ADHD Lowest is best, 0-78
2 years
Neurocognitive status: Vineland
Vineland Adaptive Behavior Scales, 20 to 160, highest is best
2 years
MRI of the brain
% of patients with anatomic anomalies on MRI of the brain
6 years
Neurocognitive: Movement ABC
Neurocognitive test panel depending on age Movement Assessment Battery for Children, mean 10 SD 3, highest is best
6 years
Neurocognitive status: WISC-IV
WISC-IV Wechsler Intelligence Scale for Children, 40 to 160, highest is best
6 years
Neurocognitive status: Auditory Verbal Learning Test/ToMaL
Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best
6 years
Neurocognitive status: TEA-Ch
TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best
6 years
Neurocognitive status: BADS-C
BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best
6 years
Neurocognitive status: Test of Visual Perceptual Skills
Test of Visual Perceptual Skills Percentile, highest is best
6 years
Neurocognitive status: The Beery Visuo-Motor Integration test
The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best
6 years
Neurocognitive status: CANTAB
CANTAB Cambridge Neuropsychological Test Automated Battery
6 years
Neurocognitive status: BRIEF 2
BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best
6 years
Neurocognitive status: ADHD screening
ADHD screening Lowest is best, 0-78
6 years
Neurocognitive status: SRS-2
SRS-2 Social Responsiveness Scale, 32-114. lowest is best
6 years
Neurocognitive status: Kiddie-Sads
Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best
6 years
Neurocognitive status: CBCL
CBCL Child Behavior Checklist, percentile, lowest is best
6 years
Neurocognitive status: Vineland
Vineland Vineland Adaptive Behavior Scales, 20 to 160, highest is best
6 years
MRI of the brain
% of patients with anatomic anomalies on MRI of the brain
11 years
Neurocognitive status: Movement ABC
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
11 years
Neurocognitive status: WISC-IV
WISC-IV Wechsler Intelligence Scale for Children, 40 to 160, highest is best
11 years
Neurocognitive status: Auditory Verbal Learning Test/ToMaL
Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best
11 years
Neurocognitive status:TEA-Ch
TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best
11 years
Neurocognitive status: BADS-C
BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best
11 years
Neurocognitive status: Test of Visual Perceptual Skills
Test of Visual Perceptual Skills Percentile, highest is best
11 years
Neurocognitive status: The Beery Visuo-Motor Integration test
The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best
11 years
Neurocognitive status: CANTAB
CANTAB Cambridge Neuropsychological Test Automated Battery
11 years
Neurocognitive status: BRIEF 2
BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best
11 years
Neurocognitive status: ADHD screening
ADHD screening Lowest is best, 0-78
11 years
Neurocognitive status: SRS-2
SRS-2 Social Responsiveness Scale, 32-114. lowest is best
11 years
Neurocognitive status: Kiddie-Sads
Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best
11 years
Neurocognitive status: CBCL
CBCL Child Behavior Checklist, percentile, lowest is best
11 years
Neurocognitive status: Vineland
Vineland Adaptive Behavior Scales, 20 to 160, highest is best
11 years
MRI of the brain
% of patients with anatomic anomalies on MRI of the brain
16 years
Neurocognitive status: Movement ABC
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
16 years
Neurocognitive status: WISC-IV
WISC-IV Wechsler Adult Intelligence Scale, 40-160, highest is best
16 years
Neurocognitive status: Auditory Verbal Learning Test/ToMaL
Auditory Verbal Learning Test/ToMaL Mean 10 SD 3, highest is best
16 years
Neurocognitive status: TEA-Ch
TEA-Ch Test of Everyday Attention for Children, normalized to z-score, highest is best
16 years
Neurocognitive status: BADS-C
BADS-C Behavioural Assessment of the Dysexecutive Syndrome in Children, 0-24, mean 10 SD 3, highest is best
16 years
Neurocognitive status: Test of Visual Perceptual Skills
Test of Visual Perceptual Skills Percentile, highest is best
16 years
Neurocognitive status: The Beery Visuo-Motor Integration test
The Beery Visuo-Motor Integration test Mean of 100 and standard deviation of 15, highest is best
16 years
Neurocognitive status: CANTAB
CANTAB Cambridge Neuropsychological Test Automated Battery
16 years
Neurocognitive status: BRIEF 2
BRIEF 2 Behaviour Rating Inventory of Executive Function, percentile, lowest is best
16 years
Neurocognitive status: ADHD screening
ADHD screening Lowest is best, 0-78
16 years
Neurocognitive status: SRS-2
SRS-2 Social Responsiveness Scale, 32-114. lowest is best
16 years
Neurocognitive status: Kiddie-Sads
Kiddie-Sads Kiddie Schedule for Affective Disorders and Schizophrenia, 0-61, lowest is best
16 years
Neurocognitive status: CBCL
CBCL Child Behavior Checklist, percentile, lowest is best
16 years
Neurocognitive status: Vineland
Vineland Adaptive Behavior Scales, 20 to 160, highest is best
16 years
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 1, 2022
Record last verified: 2022-05
No allowed from Danish government
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Source: ClinicalTrials.gov.
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