Caustic Esophageal Burns in Children and High Doses of Methylprednisolone

Esophageal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002078
• Other study ID #: ClinicalTrials.gov
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2013
• Last updated: November 28, 2013
• Start date: February 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2013
• Source: Sisli Etfal Training & Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 17 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Esophageal Diseases

Intervention

Drug:
• methylprednisolon

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Etfal Training & Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	three years	Yes