Working… Menu

Caustic Esophageal Burns in Children and High Doses of Methylprednisolone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02002078
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : December 5, 2013
Information provided by (Responsible Party):
Merve Usta, Sisli Hamidiye Etfal Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Esophageal Diseases Drug: methylprednisolon Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children
Study Start Date : February 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
No Intervention: Methylprednisolone, caustic burns Drug: methylprednisolon

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merve Usta, DR, Sisli Hamidiye Etfal Training and Research Hospital Identifier: NCT02002078    
Other Study ID Numbers:
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: November 2013
Keywords provided by Merve Usta, Sisli Hamidiye Etfal Training and Research Hospital:
corticosteroid therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents