Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-27
Brief Title:
Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital
Sponsor:
Youssef Khalifa Fakher Botros
Organization:
Assiut University
Study Overview
Official Title:
Risk Factors and Frequency of Acute Idiopathic Hepatitis in Children at Assiut Children Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
2 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 IUL and jaundice Most cases did not have fever
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 IUL and jaundice Most cases did not have fever
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None