Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children HospitalNCT06454760
Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital
An observational study of Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital, run by Youssef Khalifa Fakher Botros.
Trial 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 more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- Child
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.
Who may be able to join
- All patients aged 1year to 16 years who presented with acute hepatitis were included in the study
Who cannot join
- Patients with liver cirrhosis
- patients withliver fibrosis
- patients with hepatic cell failure
- patients with hepatic malignancy.
Trial locations and contacts
No sites are listed yet.
About this study
- Determine the predisposing factors of acute hepatitis caused by heptotropic and non-hepatotropic viruses in children attending Assiut Children Hospital .
- 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.
- Conditions
- Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital
- Keywords
- Hepatitis
- Medical subject headings
- Hepatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: for about two weeks after recovery from the acute attack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children HospitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youssef Khalifa Fakher Botros
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Youssef Khalifa Fakher Botros, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454760
- Sponsor's protocol ID
- Acute idiopathic hepatitis
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital
- ClinicalTrials.gov ID
- NCT06454760
- Acronym / sponsor ID
- Acute idiopathic hepatitis
- Conditions
- Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital
- Keywords
- Hepatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Youssef Khalifa Fakher BotrosUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Determine the predisposing factors of acute hepatitis caused by heptotropic and non-hepatotropic viruses in children attending Assiut Children Hospital .
- Determine the frequency of acute hepatitis caused by hepatotropic and non-hepatotropic viruses in children attending Assiut Children Hospital
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- All patients aged 1year to 16 years who presented with acute hepatitis were included in the study
Key exclusion criteria (4 listed)
- Patients with liver cirrhosis
- patients withliver fibrosis
- patients with hepatic cell failure
- patients with hepatic malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body mass index observation
Time frame: for about two weeks after recovery from the acute attack
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital, run by Youssef Khalifa Fakher Botros.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youssef Khalifa Fakher, Resident (01092895790, youssefkhalifa730@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index observation (time frame: for about two weeks after recovery from the acute attack). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.