Risk Factors and Outcomes of Hepatitis A in Children

NCT07848321 | Not Yet Recruiting

• 1 other identifier: HAV-Children-Assiut-2026
• Study Type: observational
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective observational study aims to evaluate the risk factors, clinical course, and outcomes among children with acute hepatitis A infection admitted to Assiut University Children Hospital.

Conditions

Hepatitis A; Acute Hepatitis

Keywords

Hepatitis A; Assiut; Children; Acute liver failure

Outcome Measures

Primary Outcomes (1)

• Proportion of children with unfavorable outcome

  Proportion of children who develop one or more of the following during hospital stay: acute liver failure, hepatic encephalopathy, acute kidney injury, ICU admission, prolonged hospital stay (\>7 days), or death.

  Baseline

Secondary Outcomes (5)

• Proportion of children with acute liver failure

  Baseline

• Proportion of children with hepatic encephalopathy

  Baseline

• Mean duration of hospital stay

  Baseline

• Proportion of children requiring ICU admission

  Baseline

• Mortality rate

  Baseline

Study Arms (1)

Single cohort: Children with acute hepatitis A

Children aged 1 month to 18 years with confirmed acute hepatitis A infection who will be followed during hospital stay to assess clinical course and outcomes.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with confirmed acute hepatitis A infection admitted to or presenting at Assiut University Children Hospital.

You may qualify if:

• Age 1 month to 18 years
• Confirmed acute hepatitis A infection by positive Anti-HAV IgM
• Written informed consent from parents or legal guardians

You may not qualify if:

• \- Co-infection with hepatitis B, hepatitis C, or hepatitis E
• Chronic liver diseases (autoimmune hepatitis, Wilson disease, metabolic liver diseases)

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hepatitis A; Liver Failure, Acute

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Liver Failure; Hepatic Insufficiency

Study Officials

• Ahlam B Ali, prof

  Pediatrics Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Nada A Fouad, Resident

CONTACT

+20 11 18762071; Nada.17289945@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Pediatrics

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 30, 2026
• Study Start: September 26, 2026
• Primary Completion (Estimated): September 26, 2027
• Study Completion (Estimated): March 25, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share