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Caustic Esophageal Burns in Children and High Doses of Methylprednisolone

NCT ID: NCT02002078

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Esophageal Diseases

Keywords

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caustic corticosteroid therapy stricture children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Methylprednisolone, caustic burns

Group Type NO_INTERVENTION

methylprednisolon

Intervention Type DRUG

Interventions

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methylprednisolon

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Merve Usta

DR

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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. doi: 10.1542/peds.2013-3331.

Reference Type DERIVED
PMID: 24864182 (View on PubMed)

Other Identifiers

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ClinicalTrials.gov

Identifier Type: -

Identifier Source: org_study_id