European paediatric non-alcoholic fatty liver disease registry (EU-PNAFLD): Design and rationale.
Jake P Mann, Anita Vreugdenhil, Piotr Socha...
https://pubmed.ncbi.nlm.nih.gov/30408605Actively Recruiting
Age: 0 - 18Years
All Genders
ID04190849
The European Paediatric Non-alcoholic Fatty Liver Disease Registry (EU-PNAFLD): a Prospective, Longitudinal Follow-up of Children With Non-alcoholic Fatty Liver Disease
Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2022-03-04
2000
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
T
The European Association for the Study of the Liver
Collaborating Sponsor
AI-Summary
What this Trial Is About
The European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD) brings together European centers caring for children with NAFLD, including hepatologists, endocrinologists, and scientists. This collaboration builds on existing databases and biorepositories, aligning with adult NAFLD registries to enable long-term follow-up and translational research. The study aims to support multi-center clinical trials, deepen understanding of NAFLD mechanisms, and establish the natural history of pediatric NAFLD. This observational registry includes children under 18 years diagnosed with NAFLD confirmed by imaging showing increased liver fat and excluding other causes. Diagnoses may also involve liver histology. The registry collects data over a long-term period, with up to 30 years of follow-up to monitor survival and disease progression. Participants will be followed longitudinally to assess outcomes such as survival, cardiovascular and liver morbidity, and asymptomatic liver disease progression. Data will come from clinical records, imaging, and laboratory results collected as part of routine care. This approach provides insight into the long-term impact of NAFLD in children and supports future research efforts.
CONDITIONS
Brief Title
European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)
Who Can Participate
Age: 0 - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis made under 18 years of age
- Diagnosis within the NAFLD spectrum including simple steatosis, steatosis with abnormal transaminases, NASH with or without fibrosis or cirrhosis
- Radiological evidence of hepatic steatosis such as increased echogenicity on ultrasound
- Exclusion of secondary causes including negative liver screen for HBV/HCV, normal caeruloplasmin (>0.20 g/L), no excess alcohol use, no significant alpha-1 antitrypsin phenotypes
- Optional liver histology showing >5% steatosis consistent with pediatric NAFLD
You will not qualify if you...
- Secondary fatty liver diseases such as glycogen storage diseases, Wilson disease, viral hepatitis, drug-related liver disease, autoimmune hepatitis, type 1 diabetes mellitus
- Post-transplant fatty liver
- Alcohol intake exceeding 20 grams per day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Long-term Monitoring
Duration - Up to 30 years
Participants with pediatric non-alcoholic fatty liver disease are followed over time to observe liver and cardiovascular health outcomes.
Regular follow-up visits over the course of the study
Trial Site Locations
Total: 3 locations
1
Maastricht UMC
Maastricht, Netherlands
Active, Not Recruiting
2
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
3
Birmingham Children's Hospital
Birmingham, United Kingdom
Actively Recruiting
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Research Team
J
Jake P Mann, MRCPCH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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