Caustic Esophageal Burns in Children and High Doses of Methylprednisolone

November 28, 2013 updated by: Merve Usta, Sisli Hamidiye Etfal Training and Research Hospital

High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Methylprednisolone, caustic burns
Drug: methylprednisolon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of stricture development in children with caustic esophageal burns after high doses of methylprednisolone
Time Frame: three years
stricture development was evaluated with endoscopic examination and upper gastrointestinal system series with barium swallow
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

November 28, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

December 5, 2013

Last Update Submitted That Met QC Criteria

November 28, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ClinicalTrials.gov (Registry Identifier: ClinicalTrials)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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