Caustic Esophageal Burns in Children and High Doses of Methylprednisolone

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

Tracking Information

• First Submitted Date: November 22, 2013
• First Posted Date: December 5, 2013
• Last Update Posted Date: December 5, 2013
• Study Start Date: February 2007
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 28, 2013)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Care Provider); Primary Purpose: Prevention
• Condition: Esophageal Diseases
• Intervention: Drug: methylprednisolon

Study Arms

No Intervention: Methylprednisolone, caustic burns

Intervention: Drug: methylprednisolon

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 28, 2013): 83
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Months to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02002078
• Other Study ID Numbers: ClinicalTrials.gov
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Merve Usta, Sisli Hamidiye Etfal Training and Research Hospital
• Study Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sisli Hamidiye Etfal Training and Research Hospital
• Verification Date: November 2013