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Caustic Esophageal Burns in Children and High Doses of Methylprednisolone

Primary Purpose

Esophageal Diseases

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
methylprednisolon
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Diseases focused on measuring caustic, corticosteroid therapy, stricture, children

Eligibility Criteria

12 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Corrosive substance ingested children with grade IIb esophageal burn

Exclusion Criteria:

  • Caustic substance ingested chldren grade I, IIa and grade III esophageal burns
  • Caustic subtance ingested children with signs of perforation, mediastinitis, peritonitis, sespis
  • Caustic substance ingested children with any chronic disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    Methylprednisolone, caustic burns

    Arm Description

    Outcomes

    Primary Outcome Measures

    Evaluation of stricture development in children with caustic esophageal burns after high doses of methylprednisolone
    stricture development was evaluated with endoscopic examination and upper gastrointestinal system series with barium swallow

    Secondary Outcome Measures

    Full Information

    First Posted
    November 22, 2013
    Last Updated
    November 28, 2013
    Sponsor
    Sisli Hamidiye Etfal Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02002078
    Brief Title
    Caustic Esophageal Burns in Children and High Doses of Methylprednisolone
    Official Title
    High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2007 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sisli Hamidiye Etfal Training and Research Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Corrosive substance ingestion in childhood is a public health issue in developing countries and several management protocols were proposed to prevent esophageal strictures. The role of corticosteroids in preventing corrosive-induced strictures is controversial. The investigators' aim is to study the influence of high doses of corticosteroids to prevent esophageal strictures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Diseases
    Keywords
    caustic, corticosteroid therapy, stricture, children

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    83 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Methylprednisolone, caustic burns
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    methylprednisolon
    Primary Outcome Measure Information:
    Title
    Evaluation of stricture development in children with caustic esophageal burns after high doses of methylprednisolone
    Description
    stricture development was evaluated with endoscopic examination and upper gastrointestinal system series with barium swallow
    Time Frame
    three years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -Corrosive substance ingested children with grade IIb esophageal burn Exclusion Criteria: Caustic substance ingested chldren grade I, IIa and grade III esophageal burns Caustic subtance ingested children with signs of perforation, mediastinitis, peritonitis, sespis Caustic substance ingested children with any chronic disease

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24864182
    Citation
    Usta M, Erkan T, Cokugras FC, Urganci N, Onal Z, Gulcan M, Kutlu T. High doses of methylprednisolone in the management of caustic esophageal burns. Pediatrics. 2014 Jun;133(6):E1518-24. doi: 10.1542/peds.2013-3331.
    Results Reference
    derived

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    Caustic Esophageal Burns in Children and High Doses of Methylprednisolone

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