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Not yet recruitingNCT07848321Updated Sep 30, 2026

Risk Factors and Outcomes of Hepatitis A in Children

An observational study in Hepatitis A and Acute Hepatitis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
190
Ages
1 Month to 18 Years
Sex
All
01

Study 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.

Read the detailed description

Hepatitis A virus infection is a common cause of acute hepatitis in children in Egypt. While most cases recover completely, some children may develop complications such as prolonged cholestasis, acute liver failure, or hepatic encephalopathy.

This observational study will include children aged 1 month to 18 years with confirmed acute hepatitis A infection (positive Anti-HAV IgM). Patients will be followed during their hospital stay to assess clinical course and outcomes.

02

Conditions studied

  • Hepatitis A
  • Acute Hepatitis

Keywords

  • Hepatitis A
  • Assiut
  • Children
  • Acute liver failure
03

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • - Co-infection with hepatitis B, hepatitis C, or hepatitis E
  • Chronic liver diseases (autoimmune hepatitis, Wilson disease, metabolic liver diseases)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
190 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

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.

    Time frame: Baseline

Secondary outcomes

  1. Proportion of children with acute liver failure

    Proportion of children who develop acute liver failure during hospital stay.

    Time frame: Baseline

  2. Proportion of children with hepatic encephalopathy

    Proportion of children who develop hepatic encephalopathy (any West Haven grade) during hospital stay.

    Time frame: Baseline

  3. Mean duration of hospital stay

    Mean number of days of hospitalization.

    Time frame: Baseline

  4. Proportion of children requiring ICU admission

    Proportion of children who require intensive care unit admission.

    Time frame: Baseline

  5. Mortality rate

    Proportion of children who die during hospital stay.

    Time frame: Baseline

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07848321
Lead sponsor
Assiut University
Responsible party
Nada Ashraf Fouad (Resident Physician, Department of Pediatrics, Assiut University) — Principal investigator
First posted
Sep 30, 2026
Start date
Sep 26, 2026 (estimated)
Primary completion
Sep 26, 2027 (estimated)
Completion
Mar 25, 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Nada A Fouad, Resident
Contact
Nada.17289945@med.aun.edu.eg
+20 11 18762071
Ahlam B Ali, prof
study chair · Pediatrics Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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