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Not yet recruitingNCT06454760Updated Jun 12, 2024

Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital

An observational study in Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital, sponsored by Youssef Khalifa Fakher Botros. Not yet recruiting. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2024-06-12.

Sponsored by Youssef Khalifa Fakher Botros · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
1 Year to 16 Years
Sex
All
01

Study summary

  1. Determine the predisposing factors of acute hepatitis caused by heptotropic and non-hepatotropic viruses in children attending Assiut Children Hospital .
  2. Determine the frequency of acute hepatitis caused by hepatotropic and non-hepatotropic viruses in children attending Assiut Children Hospital
Read the detailed description
  • Acute hepatitis has a wide range of repercussions. It can clear up completely and course without any symptoms and without the patient noticing its presence, but in some instances, it can also have complications, in which case it is classed as severe hepatitis. In these cases, the patient suffers from liver failure. The inflammation causes the liver to stop functioning correctly and coagulation disorders arise, which can evolve into hepatic encephalopathy (drowsiness, stupor, disorientation) and even hepatic coma.
  • In some cases, infection persists over time and develops into chronic hepatitis, which is when the inflammation of the liver lasts for more than 6 months. Chronic hepatitis can evolve into fibrosis (when the liver cells are inflamed they produce a more fibrous tissue similar to scarring) and eventually cirrhosis (which is when the liver is so damaged and full of scar tissue that it progressively suffers a loss of function) or liver cancer.
  • Recent reports of acute hepatitis of unknown origin in previously healthy children have been increasing worldwide. The main characteristics of the affected children were jaundice and gastrointestinal symptoms. By May 2022, the outbreak had affected over 800 children under the age of 16 years in more than 40 countries, resulting in acute liver failure in approximately 10%, including at least 21 deaths and 38 patients requiring liver transplantation.
  • Hepatitis is an inflammation of the liver that can be caused by viral infections, alcohol consumption, toxins, medications, and certain other medical conditions. So far, the cause of these cases is unknown, and many hypotheses remain open, but hepatitis AE viruses have been ruled out.

COVID-19 vaccines have also been ruled out, as most of the children are too young and had not been vaccinated. Other possible causes, including other types of coronaviruses, other infections, or environmental causes, are being actively investigated. At this stage the role of the viruses found in some of the cases in the hepatitis pathogenesis is still unclear. No other clear epidemiological risk factors have been identified to date, including recent international travel.

* There was still no confirmed cause, although there were several different working hypotheses, such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), adenovirus serotype 41, or SARS-CoV-2 superantigen-mediated immune cell activation. Here, review early observations of the 2022 outbreak which may inform diagnosis.

The clinical syndrome in all identified cases was acute hepatitis with markedly elevated liver enzymes. Many cases reported gastrointestinal symptoms including abdominal pain, diarrhea, and vomiting that preceded presentation with severe acute hepatitis, elevated liver enzyme levels (aspartate transaminase (AST) or alanine aminotransaminase (ALT) > 500 IU/L) and jaundice. Most cases did not have fever.

02

Conditions studied

  • Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital

Keywords

  • Hepatitis
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 50 is below the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

This is the only study on the registry with Youssef Khalifa Fakher Botros as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

All children aged 1year to 16 years who presented with acute hepatitis were included in the study, and then they will be classified according to the etiology, to detect the frequency of cases with acute idiopathic hepatitis.

Inclusion criteria

  • All patients aged 1year to 16 years who presented with acute hepatitis were included in the study

Exclusion criteria

Exclusion Criteria:

  • Patients with liver cirrhosis
  • patients withliver fibrosis
  • patients with hepatic cell failure
  • patients with hepatic malignancy.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Body mass index observation

    We will observe the body mass index based on the weight and height of the child and compare that with the previous results before the attack ...for a period of two weeks after recovery. 2_Determine the frequency of acute hepatitis caused by hepatotropic and non-hepatotropic viruses in children attending Assiut Children Hospital

    Time frame: for about two weeks after recovery from the acute attack

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06454760
Lead sponsor
Youssef Khalifa Fakher Botros
Responsible party
Youssef Khalifa Fakher Botros (Resident doctor in pediatric department, Assiut University) — Sponsor-investigator
First posted
Jun 12, 2024
Start date
Sep 2024 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Jun 12, 2024

Study contacts

Youssef Khalifa Fakher, Resident
Contact
youssefkhalifa730@gmail.com
01092895790
Rehab Ibrahim Hassan, Lecturer of Paediatrics.
Contact
rehabibrahim@med.au.edu.eg
01009272624

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 Jun 2024. You cannot join it, but the record below documents what was studied.

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