Acute Hepatitis in Pediatrics
LIVERPED
1 other identifier
observational
437
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2023
CompletedFirst Submitted
Initial submission to the registry
December 1, 2024
CompletedFirst Posted
Study publicly available on registry
January 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
January 7, 2025
September 1, 2024
5.2 years
December 1, 2024
December 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Study the clinical-laboratory presentation of pediatric acute hepatitis and how it varies according to age group and different etiologies.
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.
through study completion, an average of 1 year
Eligibility Criteria
Patients aged between 0 and 17 years, arriving at the pediatric emergency room and/or admitted to the pediatric ward of the participating centers.
You may qualify if:
- Age between 0 and 17 years (extremes included).
- Access to PSP and/or hospitalized (OBI or hospitalization)
- Diagnosis of acute hepatitis
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Azienda USL di Bologna Ospedale Maggiore
Bologna, 40124, Italy
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, 40138, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2024
First Posted
January 7, 2025
Study Start
October 16, 2023
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
January 7, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share