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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

Tracking Information
First Submitted Date  ICMJE November 22, 2013
First Posted Date  ICMJE December 5, 2013
Last Update Posted Date December 5, 2013
Study Start Date  ICMJE February 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caustic Esophageal Burns in Children and High Doses of Methylprednisolone
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Esophageal Diseases
Intervention  ICMJE Drug: methylprednisolon
Study Arms  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2013)
83
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02002078
Other Study ID Numbers  ICMJE ClinicalTrials.gov
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merve Usta, Sisli Hamidiye Etfal Training and Research Hospital
Study Sponsor  ICMJE Sisli Hamidiye Etfal Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sisli Hamidiye Etfal Training and Research Hospital
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP