Investigating symptoms and blood test characteristics of acute hepatitis in children
Acute Hepatitis in Pediatrics
This study is trying to learn more about the symptoms and blood test results of children with acute hepatitis to help doctors recognize and manage the condition better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 437 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 2 sites (Bologna and 1 other locations) |
| Trial ID | NCT06761261 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize acute hepatitis in pediatric patients by documenting the frequency of various symptoms and analyzing blood test results. It will assess the occurrence of complications associated with acute hepatitis, which can range from mild to severe forms that may lead to liver failure. The study will collect data on patients aged 0 to 17 years who have been diagnosed with acute hepatitis, without interfering with their normal clinical care. By understanding the clinical presentation and laboratory findings, the study seeks to improve recognition and management of this condition in children.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 17 years who have been diagnosed with acute hepatitis.
Not a fit: Patients with mild hypertransaminasemia due to known chronic liver dysfunction or neonatal jaundice without hepatocyte involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and management of acute hepatitis in pediatric patients, leading to better outcomes.
How similar studies have performed: While there may be studies on hepatitis in adults, this specific focus on pediatric acute hepatitis is less explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Bologna and 1 other locations
- Azienda USL di Bologna Ospedale Maggiore — Bologna, Italy (Recruiting)
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Arianna Dondi
- Email: arianna.dondi@aosp.bo.it
- Phone: 0512143012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.