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NCT Number: NCT06843369

Relation Between Inflammatory Responses and Sequelae of Pediatric Corrosive Ingestion Cases in Assiut

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.

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Key information

Conditions

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

About this study

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 .

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All cases diagnosed with corrosive ingestion presented at Assiut university hospital.

Exclusion criteria

  • Cases with pre-existing inflammatory diseases
  • Cases with emergencies other than corrosive ingestion.
  • Patients with delay time more than 48hours.
  • Pediatric cases whose legal guardians are unavailable or refuse to provide consent.

Treatment and study plan

inflammatory markers

Diagnostic Test

Serum amyloid A , cbc and IL-10

Primary outcomes

  1. correlation between inflammatory responses and sequelae of Pediatric Corrosive Ingestion cases at Assiut University Hospitals

    Time frame: march 2025 to February 2026

    Blood sample will be collected to measure Complete blood Count with differential leukocytic count in percent to assess the severity of inflammation in corrosive cases

  2. assess the severity of corrosive ingestion cases clinically

    Time frame: march 2025 to February 2026

    through a questionnaire and DROOL corrosive ingestion score from 0 to 10 with 10 being the best score

Study contacts

Contact information is provided by the study sponsor or research team.

Mariam Mohamed Gamal

CONTACT

[email protected]

+201007436873

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Relation Between Inflammatory Responses and Sequelae of Pediatric Corrosive Ingestion Cases at Assiut University Hospitals

Acronym: corrosive

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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