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Caustic Esophageal Burns in Children and High Doses of Methylprednisolone

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ClinicalTrials.gov Identifier: NCT02002078
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : December 5, 2013
Sponsor:
Information provided by (Responsible Party):
Merve Usta, Sisli Hamidiye Etfal Training and Research Hospital

Study Description
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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

Study Design
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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

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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merve Usta, DR, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02002078    
Other Study ID Numbers: ClinicalTrials.gov
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:
caustic
corticosteroid therapy
stricture
children
Additional relevant MeSH terms:
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Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents