Corrosive InjurycorrosiveNCT06843369
Relation Between Inflammatory Responses and Sequelae of Pediatric Corrosive Ingestion Cases in Assiut
An observational study of Corrosive Injury, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Corrosive Injury
- What is being tested?
- inflammatory markers
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 16 years
- All sexes
- Child
Study population: Cases admitted to Assiut university hospitals with history of corrosive ingestion.
Who may be able to join
- All cases diagnosed with corrosive ingestion presented at Assiut university hospital.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Relation Between Inflammatory Responses and Sequelae of Pediatric Corrosive Ingestion Cases at Assiut University Hospitals
- Evaluation of corrosive ingestion cases presented to Assiut university hospitals .
- 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.
Read the 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 .
- Conditions
- Corrosive Injury
- Being tested
- inflammatory markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflammatory markersDiagnostic test
Serum amyloid A , cbc and IL-10
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between inflammatory responses and sequelae of Pediatric Corrosive Ingestion cases at Assiut University Hospitals
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
Measured: march 2025 to February 2026
assess the severity of corrosive ingestion cases clinically
through a questionnaire and DROOL corrosive ingestion score from 0 to 10 with 10 being the best score
Measured: march 2025 to February 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corrosive InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohamed Gamal Hassan, Assiut University
- Investigators
- hayam zakaria, prof dr, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843369
- Sponsor's protocol ID
- corrosive ingestion cases
- Acronym
- corrosive
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheng HT, Seak CJ, Cheng CC, Chen TH, Sung CM, Kang SC, Chen YJ, Ng CJ, Lee CW, Huang SW, Huang HC, Yen TH. Profiling of inflammatory cytokines in patients with caustic gastrointestinal tract injury. PLoS One. 2021 Nov 18;16(11):e0260012. doi: 10.1371/journal.pone.0260012. eCollection 2021.
PubMed 34793546Poonthottathil F, Suresh S, Nayer J, Aggarwal P. Diagnostic accuracy of drooling, reluctance, oropharynx, others, and leukocytosis score as a predictor of mortality and complications following acute corrosive ingestion. Turk J Emerg Med. 2023 Oct 3;23(4):225-231. doi: 10.4103/tjem.tjem_128_23. eCollection 2023 Oct-Dec.
PubMed 38024188
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Inflammatory Responses and Sequelae of Pediatric Corrosive Ingestion Cases at Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT06843369
- Acronym / sponsor ID
- corrosive / corrosive ingestion cases
- Conditions
- Corrosive Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 25 Feb 2025 (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.
- Evaluation of corrosive ingestion cases presented to Assiut university hospitals .
- 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 .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Cases admitted to Assiut university hospitals with history of corrosive ingestion.
Key inclusion criteria (1 listed)
- All cases diagnosed with corrosive ingestion presented at Assiut university hospital.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inflammatory markersSerum amyloid A , cbc and IL-10 | Diagnostic test | – |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 34793546Cheng HT, Seak CJ, Cheng CC, Chen TH, Sung CM, Kang SC, Chen YJ, Ng CJ, Lee CW, Huang SW, Huang HC, Yen TH. Profiling of inflammatory cytokines in patients with caustic gastrointestinal tract injury. PLoS One. 2021 Nov 18;16(11):e0260012. doi: 10.1371/journal.pone.0260012. eCollection 2021.
- Background: PubMed 38024188Poonthottathil F, Suresh S, Nayer J, Aggarwal P. Diagnostic accuracy of drooling, reluctance, oropharynx, others, and leukocytosis score as a predictor of mortality and complications following acute corrosive ingestion. Turk J Emerg Med. 2023 Oct 3;23(4):225-231. doi: 10.4103/tjem.tjem_128_23. eCollection 2023 Oct-Dec.
Related trials for Corrosive Injury
Active, not recruitingPhase 3
Evaluation of the Role of N Acetyl Cysteine and Vitamin D in Improving Outcomes After Corrosive Ingestion
Corrosive Injury
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.
hayam zakaria, prof dr study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Corrosive Injury, run by Assiut University.
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: opening soon, as of the sponsor's last update on 27 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariam Mohamed Gamal (+201007436873, mariammohamedgamal9@aun.ed.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between inflammatory responses and sequelae of Pediatric Corrosive Ingestion cases at Assiut University Hospitals (time frame: march 2025 to February 2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06843369, which also lists 2 linked publications.
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 27 Feb 2025.