NCT06843369

Brief Summary

  1. 1.Evaluation of corrosive ingestion cases presented to Assiut university hospitals .
  2. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

February 14, 2025

Last Update Submit

February 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    march 2025 to February 2026

Interventions

inflammatory markersDIAGNOSTIC_TEST

Serum amyloid A , cbc and IL-10

Eligibility Criteria

AgeUp to 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Cases admitted to Assiut university hospitals with history of corrosive ingestion.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 34793546BACKGROUND
  • Poonthottathil 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.

    PMID: 38024188BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

Study Officials

  • hayam zakaria, prof dr

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator ( Principal Investigator)

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 25, 2025

Study Start

March 1, 2025

Primary Completion

February 28, 2026

Study Completion

March 31, 2026

Last Updated

February 27, 2025

Record last verified: 2025-02