Clinical trial NCT05399745: BILACO Trial: Biliary Atresia - a Severe Complex Congenital Liver Disease
Official title: BILACO Trial: Biliary Atresia - a Severe Complex Congenital Liver Disease With High Mortality, Compromised Neurological Development, Severe Malnutrition and Unknown Etiology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biliary Atresia
Cognitive Impairment
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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


Eligibility criteria: Inclusion Criteria:

* Biliary atresia
* Tetralogy of Fallot
* Healthy controls

Exclusion Criteria:

- Not able to participate in exams

Primary outcomes:
measure: MRI of the brain
timeFrame: Inclusion
measure: Neurocognitive status: Early movement repertoire (General movement)
timeFrame: Inclusion
measure: Neurocognitive status: Alberta Infant Motor Scale
timeFrame: Inclusion
measure: Neurocognitive status: Bayley Scales of Development III
timeFrame: Inclusion
measure: Neurocognitive status: WIPPSI
timeFrame: Inclusion
measure: Neurocognitive status: ABC Movement
timeFrame: Inclusion
measure: Neurocognitive status: WISC-IV
timeFrame: Inclusion
measure: Neurocognitive status: Auditory Verbal Learning Test/ToMaL
timeFrame: Inclusion
measure: Neurocognitive status: TEA-Ch
timeFrame: Inclusion
measure: Neurocognitive status: BADS-C
timeFrame: Inclusion
measure: Neurocognitive status: Test of Visual Perceptual Skills
timeFrame: Inclusion
measure: Neurocognitive status: CANTAB
timeFrame: Inclusion
measure: Neurocognitive status: The Beery Visuo-Motor Integration test
timeFrame: Inclusion
measure: Neurocognitive status: WAIS IV
timeFrame: Inclusion
measure: Neurocognitive status: Kiddie-sads
timeFrame: Inclusion
measure: Neurocognitive status: BRIEF 1
timeFrame: Inclusion
measure: Neurocognitive status: BRIEF 2
timeFrame: Inclusion
measure: Neurocognitive status: CBCL
timeFrame: Inclusion
measure: Neurocognitive status: ADHD screening
timeFrame: Inclusion
measure: Neurocognitive status: SRS-2
timeFrame: Inclusion
measure: Neurocognitive status: Vineland
timeFrame: Inclusion
measure: MRI of the brain
timeFrame: 1 year
measure: Neurocognitive status: Alberta Infant Motor Scale
timeFrame: 1 year
measure: Neurocognitive status: Bayley Scales of Development III
timeFrame: 1 year
measure: Neurocognitive status: BRIEF 1
timeFrame: 1 year
measure: Neurocognitive status: CBCL
timeFrame: 1 year
measure: Neurocognitive status: Kiddie-Sads
timeFrame: 1 year
measure: MRI of the brain
timeFrame: 2 years
measure: Neurocognitive status: Bayley Scales of Development III
timeFrame: 2 years
measure: Neurocognitive status: BRIEF 1
timeFrame: 2 years
measure: Neurocognitive status: CBCL
timeFrame: 2 years
measure: Neurocognitive status: Kiddie-Sads
timeFrame: 2 years
measure: Neurocognitive status: ADHD
timeFrame: 2 years
measure: Neurocognitive status: Vineland
timeFrame: 2 years
measure: MRI of the brain
timeFrame: 6 years
measure: Neurocognitive: Movement ABC
timeFrame: 6 years
measure: Neurocognitive status: WISC-IV
timeFrame: 6 years
measure: Neurocognitive status: Auditory Verbal Learning Test/ToMaL
timeFrame: 6 years
measure: Neurocognitive status: TEA-Ch
timeFrame: 6 years
measure: Neurocognitive status: BADS-C
timeFrame: 6 years
measure: Neurocognitive status: Test of Visual Perceptual Skills
timeFrame: 6 years
measure: Neurocognitive status: The Beery Visuo-Motor Integration test
timeFrame: 6 years
measure: Neurocognitive status: CANTAB
timeFrame: 6 years
measure: Neurocognitive status: BRIEF 2
timeFrame: 6 years
measure: Neurocognitive status: ADHD screening
timeFrame: 6 years
measure: Neurocognitive status: SRS-2
timeFrame: 6 years
measure: Neurocognitive status: Kiddie-Sads
timeFrame: 6 years
measure: Neurocognitive status: CBCL
timeFrame: 6 years
measure: Neurocognitive status: Vineland
timeFrame: 6 years
measure: MRI of the brain
timeFrame: 11 years
measure: Neurocognitive status: Movement ABC
timeFrame: 11 years
measure: Neurocognitive status: WISC-IV
timeFrame: 11 years
measure: Neurocognitive status: Auditory Verbal Learning Test/ToMaL
timeFrame: 11 years
measure: Neurocognitive status:TEA-Ch
timeFrame: 11 years
measure: Neurocognitive status: BADS-C
timeFrame: 11 years
measure: Neurocognitive status: Test of Visual Perceptual Skills
timeFrame: 11 years
measure: Neurocognitive status: The Beery Visuo-Motor Integration test
timeFrame: 11 years
measure: Neurocognitive status: CANTAB
timeFrame: 11 years
measure: Neurocognitive status: BRIEF 2
timeFrame: 11 years
measure: Neurocognitive status: ADHD screening
timeFrame: 11 years
measure: Neurocognitive status: SRS-2
timeFrame: 11 years
measure: Neurocognitive status: Kiddie-Sads
timeFrame: 11 years
measure: Neurocognitive status: CBCL
timeFrame: 11 years
measure: Neurocognitive status: Vineland
timeFrame: 11 years
measure: MRI of the brain
timeFrame: 16 years
measure: Neurocognitive status: Movement ABC
timeFrame: 16 years
measure: Neurocognitive status: WISC-IV
timeFrame: 16 years
measure: Neurocognitive status: Auditory Verbal Learning Test/ToMaL
timeFrame: 16 years
measure: Neurocognitive status: TEA-Ch
timeFrame: 16 years
measure: Neurocognitive status: BADS-C
timeFrame: 16 years
measure: Neurocognitive status: Test of Visual Perceptual Skills
timeFrame: 16 years
measure: Neurocognitive status: The Beery Visuo-Motor Integration test
timeFrame: 16 years
measure: Neurocognitive status: CANTAB
timeFrame: 16 years
measure: Neurocognitive status: BRIEF 2
timeFrame: 16 years
measure: Neurocognitive status: ADHD screening
timeFrame: 16 years
measure: Neurocognitive status: SRS-2
timeFrame: 16 years
measure: Neurocognitive status: Kiddie-Sads
timeFrame: 16 years
measure: Neurocognitive status: CBCL
timeFrame: 16 years
measure: Neurocognitive status: Vineland
timeFrame: 16 years
Secondary outcomes:
measure: Genetics: Whole genome sequencing of blood
timeFrame: Inclusion
measure: Genetics: Whole genome sequencing of liver biopsy
timeFrame: Inclusion
measure: Microbiome: Urine proteomics
timeFrame: Inclusion
measure: Microbiome: Feces proteomics
timeFrame: Inclusion
measure: Microbiome: Saliva proteomics
timeFrame: Inclusion
measure: Microbiome: Feces Next Generation Sequencing of microbial DNA
timeFrame: Inclusion
measure: Microbiome: Urine Next Generation Sequencing of microbial DNA
timeFrame: Inclusion
measure: Microbiome: Saliva Next Generation Sequencing of microbial DNA
timeFrame: Inclusion
measure: Microbiome: Feces metabolomics
timeFrame: Inclusion
measure: Microbiome: Urine metabolomics
timeFrame: Inclusion
measure: Microbiome: Saliva metabolomics
timeFrame: Inclusion
measure: Microbiome: Feces metatranscriptomics
timeFrame: Inclusion
measure: Microbiome: Urine metatranscriptomics
timeFrame: Inclusion
measure: Microbiome: Saliva metatranscriptomics
timeFrame: Inclusion
measure: Genetics: Whole genome sequencing of blood
timeFrame: 1 year
measure: Genetics: Whole genome sequencing of liver biopsy
timeFrame: 1 year
measure: Microbiome: Feces metatranscriptomics
timeFrame: 1 year
measure: Microbiome: Urine metatranscriptomics
timeFrame: 1 year
measure: Microbiome: Saliva metatranscriptomics
timeFrame: 1 year
measure: Microbiome: Urine Next Generation Sequencing of microbial DNA
timeFrame: 1 year
measure: Microbiome: Feces Next Generation Sequencing of microbial DNA
timeFrame: 1 year
measure: Microbiome: Saliva Next Generation Sequencing of microbial DNA
timeFrame: 1 year
measure: Microbiome: Saliva metabolomics
timeFrame: 1 year
measure: Microbiome: Urine metabolomics
timeFrame: 1 year
measure: Microbiome: Feces metabolomics
timeFrame: 1 year
measure: Microbiome: Saliva proteomics
timeFrame: 1 year
measure: Microbiome: Urine proteomics
timeFrame: 1 year
measure: Microbiome: Feces proteomics
timeFrame: 1 year
measure: Genetics: Whole genome sequencing of blood
timeFrame: 2 years
measure: Genetics: Whole genome sequencing of liver biopsy
timeFrame: 2 years
measure: Microbiome: Feces metatranscriptomics
timeFrame: 2 years
measure: Microbiome: Urine metatranscriptomics
timeFrame: 2 years
measure: Microbiome: Saliva metatranscriptomics
timeFrame: 2 years
measure: Microbiome: Saliva metabolomics
timeFrame: 2 years
measure: Microbiome: Feces metabolomics
timeFrame: 2 years
measure: Microbiome: Urine metabolomics
timeFrame: 2 years
measure: Microbiome: Urine proteomics
timeFrame: 2 years
measure: Microbiome: Feces proteomics
timeFrame: 2 years
measure: Microbiome: Saliva proteomics
timeFrame: 2 years
measure: Microbiome: Urine Next Generation Sequencing of microbial DNA
timeFrame: 2 years
measure: Microbiome: Saliva Next Generation Sequencing of microbial DNA
timeFrame: 2 years
measure: Microbiome: Feces Next Generation Sequencing of microbial DNA
timeFrame: 2 years
measure: Genetics: Whole genome sequencing of blood
timeFrame: 6 years
measure: Genetics: Whole genome sequencing of liver biopsy
timeFrame: 6 years
measure: Microbiome: Feces Next Generation Sequencing of microbial DNA
timeFrame: 6 years
measure: Microbiome: Feces metatranscriptomics
timeFrame: 6 years
measure: Microbiome: Feces metabolomics
timeFrame: 6 years
measure: Microbiome: Feces proteomics
timeFrame: 6 years
measure: Microbiome: Urine Next Generation Sequencing of microbial DNA
timeFrame: 6 years
measure: Microbiome: Urine metatranscriptomics
timeFrame: 6 years
measure: Microbiome: Urine metabolomics
timeFrame: 6 years
measure: Microbiome: Urine proteomics
timeFrame: 6 years
measure: Microbiome: Saliva Next Generation Sequencing of microbial DNA
timeFrame: 6 years
measure: Microbiome: Saliva metatranscriptomics
timeFrame: 6 years
measure: Microbiome: Saliva metabolomics
timeFrame: 6 years
measure: Microbiome: Saliva proteomics
timeFrame: 6 years
measure: Genetics: Whole genome sequencing of blood
timeFrame: 11 years
measure: Genetics: Whole genome sequencing of liver biopsy
timeFrame: 11 years
measure: Microbiome: Feces Next Generation Sequencing of microbial DNA
timeFrame: 11 years
measure: Microbiome: Feces metatranscriptomics
timeFrame: 11 years
measure: Microbiome: Feces metabolomics
timeFrame: 11 years
measure: Microbiome: Feces proteomics
timeFrame: 11 years
measure: Microbiome: Urine Next Generation Sequencing of microbial DNA
timeFrame: 11 years
measure: Microbiome: Urine metatranscriptomics
timeFrame: 11 years
measure: Microbiome: Urine metabolomics
timeFrame: 11 years
measure: Microbiome: Urine proteomics
timeFrame: 11 years
measure: Microbiome: Saliva Next Generation Sequencing of microbial DNA
timeFrame: 11 years
measure: Microbiome: Saliva metatranscriptomics
timeFrame: 11 years
measure: Microbiome: Saliva metabolomics
timeFrame: 11 years
measure: Microbiome: Saliva proteomics
timeFrame: 11 years
measure: Genetics: Whole genome sequencing of blood
timeFrame: 16 years
measure: Genetics: Whole genome sequencing of liver biopsy
timeFrame: 16 years
measure: Microbiome: Feces metatranscriptomics
timeFrame: 16 years
measure: Microbiome: Feces Next Generation Sequencing of microbial DNA
timeFrame: 16 years
measure: Microbiome: Feces metabolomics
timeFrame: 16 years
measure: Microbiome: Feces proteomics
timeFrame: 16 years
measure: Microbiome: Urine metatranscriptomics
timeFrame: 16 years
measure: Microbiome: Urine Next Generation Sequencing of microbial DNA
timeFrame: 16 years
measure: Microbiome: Urine metabolomics
timeFrame: 16 years
measure: Microbiome: Urine proteomics
timeFrame: 16 years
measure: Microbiome: Saliva metatranscriptomics
timeFrame: 16 years
measure: Microbiome: Saliva Next Generation Sequencing of microbial DNA
timeFrame: 16 years
measure: Microbiome: Saliva metabolomics
timeFrame: 16 years
measure: Microbiome: Saliva proteomics
timeFrame: 16 years
measure: Status of the cardiac system: Ultrasound of the heart
timeFrame: Inclusion
measure: Status of the cardiac system: MRI of the lymph system
timeFrame: Inclusion
measure: Status of the cardiac system: Near Infrared Fluorescence of the lymph system
timeFrame: Inclusion
measure: Status of the cardiac system: Ultrasound of the heart
timeFrame: 1 year
measure: Status of the cardiac system: MRI of the lymph system
timeFrame: 1 year
measure: Status of the cardiac system: Near Infrared Fluorescence of the lymph system
timeFrame: 1 year
measure: Status of the cardiac system: Ultrasound of the heart
timeFrame: 2 years
measure: Status of the cardiac system: MRI of the lymph system
timeFrame: 2 years
measure: Status of the cardiac system: Near Infrared Fluorescence of the lymph system
timeFrame: 2 years
measure: Status of the cardiac system: Ultrasound of the heart
timeFrame: 6 years
measure: Status of the cardiac system: MRI of the lymph system
timeFrame: 6 years
measure: Status of the cardiac system: Near Infrared Fluorescence of the lymph system
timeFrame: 6 years
measure: Status of the cardiac system: Ultrasound of the heart
timeFrame: 11 years
measure: Status of the cardiac system: MRI of the lymph system
timeFrame: 11 years
measure: Status of the cardiac system: Near Infrared Fluorescence of the lymph system
timeFrame: 11 years
measure: Status of the cardiac system: Ultrasound of the heart
timeFrame: 16 years
measure: Status of the cardiac system: MRI of the lymph system
timeFrame: 16 years
measure: Status of the cardiac system: Near Infrared Fluorescence of the lymph system
timeFrame: 16 years
measure: Level of Physical activity
timeFrame: Inclusion
measure: Level of Physical activity
timeFrame: 1 year
measure: Level of Physical activity
timeFrame: 2 years
measure: Level of Physical activity
timeFrame: 6 years
measure: Level of Physical activity
timeFrame: 11 years
measure: Level of Physical activity
timeFrame: 16 years
measure: Ultrasound of liver and bile ducts with elastography
timeFrame: Inclusion
measure: Liver biopsy
timeFrame: Inclusion
measure: FGF-19; Fibroblast growth factor 19
timeFrame: Inclusion
measure: ELF-score: Enhanced Liver Fibrosis
timeFrame: Inclusion
measure: INR: international normalized ratio
timeFrame: Inclusion
measure: prothrombin+proconvertin (PP)
timeFrame: Inclusion
measure: ALAT: alanine transaminase
timeFrame: Inclusion
measure: GGT: Gamma-glutamyl transferase
timeFrame: Inclusion
measure: Bilirubin
timeFrame: Inclusion
measure: ASAT: Aspartate transaminase
timeFrame: Inclusion
measure: Alkaline phosphatase
timeFrame: Inclusion
measure: Ammonia
timeFrame: Inclusion
measure: Thrombocytes
timeFrame: Inclusion
measure: Ultrasound of liver and bile ducts with elastography
timeFrame: 1 year
measure: FGF-19: Fibroblast growth factor 19
timeFrame: 1 year
measure: ELF-score: Enhanced Liver Fibrosis
timeFrame: 1 year
measure: INR: international normalized ratio
timeFrame: 1 year
measure: prothrombin+proconvertin (PP)
timeFrame: 1 year
measure: ALAT: alanine transaminase
timeFrame: 1 year
measure: ASAT: Aspartate transaminase
timeFrame: 1 year
measure: GGT: Gamma-glutamyl transferase
timeFrame: 1 year
measure: Bilirubin
timeFrame: 1 year
measure: Alkaline phosphatase
timeFrame: 1 year
measure: Ammonia
timeFrame: 1 year
measure: Thrombocytes
timeFrame: 1 year
measure: Liver biopsy
timeFrame: 1 year
measure: Ultrasound of liver and bile ducts with elastography
timeFrame: 2 years
measure: FGF-19: Fibroblast growth factor 19
timeFrame: 2 years
measure: ELF-score: Enhanced Liver Fibrosis
timeFrame: 2 years
measure: Liver biopsy
timeFrame: 2 years
measure: INR: international normalized ratio
timeFrame: 2 years
measure: prothrombin+proconvertin (PP)
timeFrame: 2 years
measure: ALAT: alanine transaminase
timeFrame: 2 years
measure: ASAT: Aspartate transaminase
timeFrame: 2 years
measure: GGT: Gamma-glutamyl transferase
timeFrame: 2 years
measure: Alkaline phosphatase
timeFrame: 2 years
measure: Bilirubin
timeFrame: 2 years
measure: Ammonia
timeFrame: 2 years
measure: Thrombocytes
timeFrame: 2 years
measure: Ultrasound of liver and bile ducts with elastography
timeFrame: 6 years
measure: Liver biopsy
timeFrame: 6 years
measure: ELF-score: Enhanced Liver Fibrosis
timeFrame: 6 years
measure: FGF-19: Fibroblast growth factor 19
timeFrame: 6 years
measure: INR: international normalized ratio
timeFrame: 6 years
measure: prothrombin+proconvertin (PP)
timeFrame: 6 years
measure: ALAT: alanine transaminase
timeFrame: 6 years
measure: ASAT: Aspartate transaminase
timeFrame: 6 years
measure: GGT: Gamma-glutamyl transferase
timeFrame: 6 years
measure: Bilirubin
timeFrame: 6 years
measure: Alkaline phosphatase
timeFrame: 6 years
measure: Ammonia
timeFrame: 6 years
measure: Thrombocytes
timeFrame: 6 years
measure: Ultrasound of liver and bile ducts with elastography
timeFrame: 11 years
measure: Liver biopsy
timeFrame: 11 years
measure: FGF-19: Fibroblast growth factor 19
timeFrame: 11 years
measure: ELF-score: Enhanced Liver Fibrosis
timeFrame: 11 years
measure: INR: international normalized ratio
timeFrame: 11 years
measure: prothrombin+proconvertin (PP)
timeFrame: 11 years
measure: ALAT: alanine transaminase
timeFrame: 11 years
measure: ASAT: Aspartate transaminase
timeFrame: 11 years
measure: GGT: Gamma-glutamyl transferase
timeFrame: 11 years
measure: Bilirubin
timeFrame: 11 years
measure: Alkaline phosphatase
timeFrame: 11 years
measure: Ammonia
timeFrame: 11 years
measure: Thrombocytes
timeFrame: 11 years
measure: Ultrasound of liver and bile ducts with elastography
timeFrame: 16 years
measure: Liver biopsy
timeFrame: 16 years
measure: FGF-19: Fibroblast growth factor 19
timeFrame: 16 years
measure: ELF-score: Enhanced Liver Fibrosis
timeFrame: 16 years
measure: INR: international normalized ratio
timeFrame: 16 years
measure: prothrombin+proconvertin (PP)
timeFrame: 16 years
measure: ALAT: alanine transaminase
timeFrame: 16 years
measure: ASAT: Aspartate transaminase
timeFrame: 16 years
measure: GGT: Gamma-glutamyl transferase
timeFrame: 16 years
measure: Bilirubin
timeFrame: 16 years
measure: Alkaline phosphatase
timeFrame: 16 years
measure: Ammonia
timeFrame: 16 years
measure: Thrombocytes
timeFrame: 16 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: Inclusion
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 1 year
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 2 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 6 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 11 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 16 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: Inclusion
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 1 year
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 2 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 6 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 11 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 16 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: Inclusion
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 1 year
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 2 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 6 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 11 years
measure: Clinical examination: Cirrhosis stigmata
timeFrame: 16 years
measure: Anthropometry: Length
timeFrame: Inclusion
measure: Anthropometry: Length
timeFrame: 1 year
measure: Anthropometry: Length
timeFrame: 2 years
measure: Anthropometry: Height
timeFrame: 6 years
measure: Anthropometry: Height
timeFrame: 11 years
measure: Anthropometry: Height
timeFrame: 16 years
measure: Anthropometry: Weight
timeFrame: Inclusion
measure: Anthropometry: Weight
timeFrame: 1 year
measure: Anthropometry: Weight
timeFrame: 2 years
measure: Anthropometry: Weight
timeFrame: 6 years
measure: Anthropometry: Weight
timeFrame: 11 years
measure: Anthropometry: Weight
timeFrame: 16 years
measure: Anthropometry: Mid-upper arm circumference (MUAC)
timeFrame: Inclusion
measure: Anthropometry: Mid-upper arm circumference (MUAC)
timeFrame: 1 year
measure: Anthropometry: Mid-upper arm circumference (MUAC)
timeFrame: 2 years
measure: Anthropometry: Mid-upper arm circumference (MUAC)
timeFrame: 6 years
measure: Anthropometry: Mid-upper arm circumference (MUAC)
timeFrame: 11 years
measure: Anthropometry: Mid-upper arm circumference (MUAC)
timeFrame: 16 years
measure: Anthropometry: Head circumference
timeFrame: Inclusion
measure: Anthropometry: Head circumference
timeFrame: 1 year
measure: Anthropometry: Head circumference
timeFrame: 2 years
measure: Anthropometry: Head circumference
timeFrame: 6 years
measure: Anthropometry: Head circumference
timeFrame: 11 years
measure: Anthropometry: Head circumference
timeFrame: 16 years
measure: Essential fatty acids
timeFrame: Inclusion
measure: Essential fatty acids
timeFrame: 1 year
measure: Essential fatty acids
timeFrame: 2 years
measure: Essential fatty acids
timeFrame: 6 years
measure: Essential fatty acids
timeFrame: 11 years
measure: Essential fatty acids
timeFrame: 16 years
measure: IGF-1
timeFrame: Inclusion
measure: IGF-1
timeFrame: 1 year
measure: IGF-1
timeFrame: 2 years
measure: IGF-1
timeFrame: 6 years
measure: IGF-1
timeFrame: 11 years
measure: IGF-1
timeFrame: 16 years
measure: Meal stimulation measuring incretin
timeFrame: Inclusion
measure: Meal stimulation measuring incretin
timeFrame: 1 year
measure: Meal stimulation measuring incretin
timeFrame: 2 years
measure: Meal stimulation measuring incretin
timeFrame: 6 years
measure: Meal stimulation measuring incretin
timeFrame: 11 years
measure: Meal stimulation measuring incretin
timeFrame: 16 years
measure: Bile acid
timeFrame: Inclusion
measure: Bile acid
timeFrame: 1 year
measure: Bile acid
timeFrame: 2 years
measure: Bile acid
timeFrame: 6 years
measure: Bile acid
timeFrame: 11 years
measure: Bile acid
timeFrame: 16 years
measure: Autotaxin
timeFrame: Inclusion
measure: Autotaxin
timeFrame: 1 year
measure: Autotaxin
timeFrame: 2 years
measure: Autotaxin
timeFrame: 6 years
measure: Autotaxin
timeFrame: 11 years
measure: Autotaxin
timeFrame: 16 years
measure: EDTA clearance
timeFrame: Inclusion
measure: EDTA clearance
timeFrame: 1 year
measure: EDTA clearance
timeFrame: 2 years
measure: EDTA clearance
timeFrame: 6 years
measure: EDTA clearance
timeFrame: 11 years
measure: EDTA clearance
timeFrame: 16 years
measure: Vaccination status
timeFrame: Inclusion
measure: Vaccination status
timeFrame: 1 year
measure: Vaccination status
timeFrame: 2 years
measure: Vaccination status
timeFrame: 6 years
measure: Vaccination status
timeFrame: 11 years
measure: Vaccination status
timeFrame: 16 years
measure: Immunoresponse: RTE
timeFrame: Inclusion
measure: Immunoresponse: RTE
timeFrame: 1 year
measure: Immunoresponse: RTE
timeFrame: 2 years
measure: Immunoresponse: RTE
timeFrame: 6 years
measure: Immunoresponse: RTE
timeFrame: 11 years
measure: Immunoresponse: RTE
timeFrame: 16 years
measure: Immunoresponse: Flow panel
timeFrame: Inclusion
measure: Immunoresponse: Flow panel
timeFrame: 1 year
measure: Immunoresponse: Flow panel
timeFrame: 2 years
measure: Immunoresponse: Flow panel
timeFrame: 6 years
measure: Immunoresponse: Flow panel
timeFrame: 11 years
measure: Immunoresponse: Flow panel
timeFrame: 16 years
measure: Immunoresponse: Immunoglobulin
timeFrame: Inclusion
measure: Immunoresponse: Immunoglobulin
timeFrame: 1 year
measure: Immunoresponse: Immunoglobulin
timeFrame: 2 years
measure: Immunoresponse: Immunoglobulin
timeFrame: 6 years
measure: Immunoresponse: Immunoglobulin
timeFrame: 11 years
measure: Immunoresponse: Immunoglobulin
timeFrame: 16 years
measure: Immunoresponse: Somatic hyper mutation
timeFrame: Inclusion
measure: Immunoresponse: Somatic hyper mutation
timeFrame: 1 year
measure: Immunoresponse: Somatic hyper mutation
timeFrame: 2 years
measure: Immunoresponse: Somatic hyper mutation
timeFrame: 6 years
measure: Immunoresponse: Somatic hyper mutation
timeFrame: 11 years
measure: Immunoresponse: Somatic hyper mutation
timeFrame: 16 years
measure: Epstein-Barr Virus (EBV)
timeFrame: Inclusion
measure: Epstein-Barr Virus (EBV)
timeFrame: 1 year
measure: Epstein-Barr Virus (EBV)
timeFrame: 2 years
measure: Epstein-Barr Virus (EBV)
timeFrame: 6 years
measure: Epstein-Barr Virus (EBV)
timeFrame: 11 years
measure: Epstein-Barr Virus (EBV)
timeFrame: 16 years
measure: Cytomegalovirus (CMV)
timeFrame: Inclusion
measure: Cytomegalovirus (CMV)
timeFrame: 1 year
measure: Cytomegalovirus (CMV)
timeFrame: 2 years
measure: Cytomegalovirus (CMV)
timeFrame: 6 years
measure: Cytomegalovirus (CMV)
timeFrame: 11 years
measure: Cytomegalovirus (CMV)
timeFrame: 16 years
measure: Hepatobiliary scintigraphy
timeFrame: Inclusion
measure: Hepatobiliary scintigraphy
timeFrame: 1 year
measure: Hepatobiliary scintigraphy
timeFrame: 2 years
measure: Hepatobiliary scintigraphy
timeFrame: 6 years
measure: Hepatobiliary scintigraphy
timeFrame: 11 years
measure: Hepatobiliary scintigraphy
timeFrame: 16 years
measure: MRI of liver and bile ducts with elastography
timeFrame: Inclusion
measure: MRI of liver and bile ducts with elastography
timeFrame: 1 year
measure: MRI of liver and bile ducts with elastography
timeFrame: 2 years
measure: MRI of liver and bile ducts with elastography
timeFrame: 6 years
measure: MRI of liver and bile ducts with elastography
timeFrame: 11 years
measure: MRI of liver and bile ducts with elastography
timeFrame: 16 years
measure: Fibroscan
timeFrame: Inclusion
measure: Fibroscan
timeFrame: 1 year
measure: Fibroscan
timeFrame: 2 years
measure: Fibroscan
timeFrame: 6 years
measure: Fibroscan
timeFrame: 11 years
measure: Fibroscan
timeFrame: 16 years
measure: Indocyanine green clearance
timeFrame: Inclusion
measure: Indocyanine green clearance
timeFrame: 1 year
measure: Indocyanine green clearance
timeFrame: 2 years
measure: Indocyanine green clearance
timeFrame: 6 years
measure: Indocyanine green clearance
timeFrame: 11 years
measure: Indocyanine green clearance
timeFrame: 16 years
measure: Fecal fat measurements
timeFrame: Inclusion
measure: Fecal fat measurements
timeFrame: 1 year
measure: Fecal fat measurements
timeFrame: 2 years
measure: Fecal fat measurements
timeFrame: 6 years
measure: Fecal fat measurements
timeFrame: 11 years
measure: Fecal fat measurements
timeFrame: 16 years
measure: Thymus scan with ultrasound
timeFrame: Inclusion
measure: Thymus scan with ultrasound
timeFrame: 1 year
measure: Thymus scan with ultrasound
timeFrame: 2 years
measure: Thymus scan with ultrasound
timeFrame: 6 years
measure: Thymus scan with ultrasound
timeFrame: 11 years
measure: Thymus scan with ultrasound
timeFrame: 16 years
measure: DEXA scan
timeFrame: Inclusion
measure: DEXA scan
timeFrame: 1 year
measure: DEXA scan
timeFrame: 2 years
measure: DEXA scan
timeFrame: 6 years
measure: DEXA scan
timeFrame: 11 years
measure: DEXA scan
timeFrame: 16 years
measure: PEDS-QL
timeFrame: Inclusion
measure: PEDS-QL
timeFrame: 1 year
measure: PEDS-QL
timeFrame: 2 years
measure: PEDS-QL
timeFrame: 6 years
measure: PEDS-QL
timeFrame: 11 years
measure: PEDS-QL
timeFrame: 16 years
measure: Leptin
timeFrame: Inclusion
measure: Leptin
timeFrame: 1 year
measure: Leptin
timeFrame: 2 years
measure: Leptin
timeFrame: 6 years
measure: Leptin
timeFrame: 11 years
measure: Leptin
timeFrame: 16 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Vibeke Brix Christensen, MD, PhD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: