Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-30 @ 10:00 PM
Study NCT ID:
NCT06843369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-27
First Post:
2025-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relation Between Inflammatory Responses and Sequelae of Pediatric Corrosive Ingestion Cases in Assiut
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Relation Between Inflammatory Responses and Sequelae of Pediatric Corrosive Ingestion Cases at Assiut University Hospitals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
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:
corrosive
Brief Summary:
1. Evaluation of corrosive ingestion cases presented to Assiut university hospitals .
2. To assess the role of leukocytic parameters and inflammatory mediators in determining the severity of pediatric corrosive injuries and their correlation with long-term outcomes.
2. To assess the role of leukocytic parameters and inflammatory mediators in determining the severity of pediatric corrosive injuries and their correlation with long-term outcomes.
Detailed Description:
Inflammatory response plays a vital role in the development of gastrointestinal complications following corrosive ingestion. Leucocytic parameters: neutrophil-to-lymphocyte ratio (NLR), neutrophils count and lymphocytic count from the peripheral blood, has emerged as an easily obtainable biomarker of acute inflammation .
Inflammatory mediators play a significant role in the body's response to injury. They also have a major impact on the pathophysiology of caustic injury, as they modulate the inflammatory response and tissue damage following exposure to corrosive substances. Therefore, they can potentially serve as prognostic biomarkers to assess the severity of caustic injury .
Acute phase reactants (APR) are inflammatory markers that exhibit significant changes in serum concentration during inflammation. These are also important mediators produced in the liver during acute and chronic inflammatory states. Their concentrations increase during inflammation. Serum amyloid A protein (SAA) is a pro-inflammatory mediator, and its concentration can increase from healthy levels of less than 3 mg per liter to more than 1000 mg per liter in the presence of inflammation, and it can remain elevated for as long as the inflammatory disease remains active .
Interleukin 10 (IL-10) is an anti-inflammatory cytokine that plays a crucial role in preventing inflammatory diseases, that generally begins to increase within a few hours after the onset of injury, although its peak may not occur until later (usually within 24-48 hours). Its release is often a part of the body's feedback mechanism to balance the acute inflammatory response .
DROOL caustic ingestion score is a diagnostic tool used to evaluate patients with corrosive ingestion through these parameters: drooling, dysphagia, oropharyngeal burns, others (fever, hematemesis, abdominal tenderness) and leukocytosis. It ranges from 0 to 10, with the best score being 10 .
Inflammatory mediators play a significant role in the body's response to injury. They also have a major impact on the pathophysiology of caustic injury, as they modulate the inflammatory response and tissue damage following exposure to corrosive substances. Therefore, they can potentially serve as prognostic biomarkers to assess the severity of caustic injury .
Acute phase reactants (APR) are inflammatory markers that exhibit significant changes in serum concentration during inflammation. These are also important mediators produced in the liver during acute and chronic inflammatory states. Their concentrations increase during inflammation. Serum amyloid A protein (SAA) is a pro-inflammatory mediator, and its concentration can increase from healthy levels of less than 3 mg per liter to more than 1000 mg per liter in the presence of inflammation, and it can remain elevated for as long as the inflammatory disease remains active .
Interleukin 10 (IL-10) is an anti-inflammatory cytokine that plays a crucial role in preventing inflammatory diseases, that generally begins to increase within a few hours after the onset of injury, although its peak may not occur until later (usually within 24-48 hours). Its release is often a part of the body's feedback mechanism to balance the acute inflammatory response .
DROOL caustic ingestion score is a diagnostic tool used to evaluate patients with corrosive ingestion through these parameters: drooling, dysphagia, oropharyngeal burns, others (fever, hematemesis, abdominal tenderness) and leukocytosis. It ranges from 0 to 10, with the best score being 10 .
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?: