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Clinical Trials in Italy / NCT06761261
Recruiting Observational

Acute Hepatitis in Pediatrics

NCT06761261 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2023-10-16
Last updated
2025-01-07

Condition(s) studied

Hepatitis

Study summary

This study aims to investigate wich symptoms and blood test characteristics acute hepatitis manifests in pediatric age. The study will be conducted because acute hepatitis is not an easily and clearly recognized disease in children.

This study aims to better characterize this disease by describing the frequency of the different symptoms with which it can manifest and the changes it causes in blood tests. It also aims to assess the occurrence of any complications of pediatric acute hepatitis.

The study is observational, so it is limited to collecting data and analyzing the patient's clinical course without interfering with normal clinical practice.

Eligibility

Sex
ALL
Min age
—
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 0 and 17 years (extremes included). * Access to PSP and/or hospitalized (OBI or hospitalization) * Diagnosis of acute hepatitis Exclusion Criteria: * Refusal of the parent/guardian to participate in the study. * Mild hypertransaminasemia (\<5 times the upper limit of normal) in a patient with known chronic liver dysfunction (e.g. liver cirrhosis). * Neonatal jaundice without hepatocyte involvement or signs of cholestasis (prevalence of indirect bilirubin with normal AST, ALT and GGT).

Primary outcome measure(s)

  • Study the clinical-laboratory presentation of pediatric acute hepatitis and how it varies according to age group and different etiologies. — through study completion, an average of 1 year
    The present study aims to describe the clinical presentation and natural history of pediatric acute liver injury from the experience of Pediatric Emergency Room (PSP) units and Pediatrics departments. This would allow a better characterization of an often nonspecific picture, combining clinical and laboratory data, and studying how they change according to age group and different underlying etiologies. In addition, it would allow assessment of the frequency of pediatric ALF in the participating centers.

Trial sites (2)

FacilityCityRegionStatus
Azienda USL di Bologna Ospedale Maggiore Bologna Italy Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna Bologna Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06761261 on ClinicalTrials.gov ↗ ← All trials in Italy