Acute Hepatitis in Pediatrics
ConditionHepatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age between 0 and 17 years (extremes included).
Access to PSP and/or hospitalized (OBI or hospitalization)
Diagnosis of acute hepatitis
Disqualifiers
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).
Trial population
Patients aged between 0 and 17 years, arriving at the pediatric emergency room and/or admitted to the pediatric ward of the participating centers.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov