Non-Alcoholic Fatty Liver Disease in children: determining the prevalence of liver fibrosis using FibroScan®

Non-Alcoholic Fatty Liver Disease in children: determining the prevalence of liver fibrosis using FibroScan® - Fibrokids

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55751

Enrollment

604

Registered

2018-01-25

Start date

2018-02-02

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fatty liver hepatic steatosis

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: • Age 8 - 18 years • Obesity (BMI >= 95th percentile) or overweight (BMI >= 85th and < 94th  percentile) with one of the following additional risk factors: central  adiposity, insulin resistance, prediabetes or diabetes, dyslipidemia, sleep  apnea, or family history of NAFLD/NASH.

Exclusion criteria

Exclusion criteria: • Age > 18 years • Other liver disease (viral/autoimmune hepatitis, M. Wilson, haemochromatosis,  alfa1-antitrypsine deficiency) • Metabolic disease (beta-oxidation defects, urea cyclus defects) • Alcohol consumption > 140 g/week • Use of steatogenic medication

Design outcomes

Primary

Measure	Time frame
1) Percentage of children with probable significant fibrosis (FibroScan® value > 7.4 kPa) when screening children based on the NASPGHAN 2017 guideline. 2) Costs of screening to find one patient with significant fibrosis. 3) - Success rate of FibroScan® measurements of M-probe and XL-probe in subjects in who XL-probe, or both XL- and M-probe is indicated by the FibroScan® apparatus. - Correlation between FibroScan® values of M-probe and XL-probe in subjects in who XL-probe, or both XL- and M-probe is indicated by the FibroScan® apparatus. - Difference in percentage positive and negative results for significant fibrosis (FibroSscan® value >/<7.4 Kpa) when using M-probe or XL-probe. - Correlation between ELF test and FibroScan® values (M-probe) - Correlation between shear wave elastography, FibroScan® (M-probe) and ELF test - Difference in percentage positive and negative results for significant fibrosis of ELF test (>/< 10.18) compared to FibroScan® M-probe (>/<7.4 kPa). 5) Difference in quality of life between children with NAFLD and healthy children and impact of fibrosis on quality of life. 6) Patient experience during screening process and illness perception	—

Measure

Time frame

1) Percentage of children with probable significant fibrosis (FibroScan® value > 7.4 kPa) when screening children based on the NASPGHAN 2017 guideline. 2) Costs of screening to find one patient with significant fibrosis. 3) - Success rate of FibroScan® measurements of M-probe and XL-probe in subjects in who XL-probe, or both XL- and M-probe is indicated by the FibroScan® apparatus. - Correlation between FibroScan® values of M-probe and XL-probe in subjects in who XL-probe, or both XL- and M-probe is indicated by the FibroScan® apparatus. - Difference in percentage positive and negative results for significant fibrosis (FibroSscan® value >/<7.4 Kpa) when using M-probe or XL-probe. - Correlation between ELF test and FibroScan® values (M-probe) - Correlation between shear wave elastography, FibroScan® (M-probe) and ELF test - Difference in percentage positive and negative results for significant fibrosis of ELF test (>/< 10.18) compared to FibroScan® M-probe (>/<7.4 kPa). 5) Difference in quality of life between children with NAFLD and healthy children and impact of fibrosis on quality of life. 6) Patient experience during screening process and illness perception

—

Secondary

Measure	Time frame
Nvt	—

Countries

Netherlands

Outcome results