NCT02002078

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
Last Updated

December 5, 2013

Status Verified

November 1, 2013

Enrollment Period

1.8 years

First QC Date

November 22, 2013

Last Update Submit

November 28, 2013

Conditions

Esophageal Diseases

Keywords

causticcorticosteroid therapystricturechildren

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Methylprednisolone, caustic burns

NO INTERVENTION
Drug: methylprednisolon

Interventions

methylprednisolonDRUG
Methylprednisolone, caustic burns

Eligibility Criteria

Age12 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Corrosive substance ingested children with grade IIb esophageal burn

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24864182DERIVED

MeSH Terms

Conditions

Esophageal DiseasesConstriction, Pathologic

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

November 22, 2013

First Posted

December 5, 2013

Study Start

February 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 5, 2013

Record last verified: 2013-11