NCT02002078已完成4 期
High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children
Sisli Hamidiye Etfal Training and Research Hospital0 个研究点目标入组 83 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 主要终点
- Evaluation of stricture development in children with caustic esophageal burns after high doses of methylprednisolone
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 12 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Corrosive substance ingested children with grade IIb esophageal burn
排除标准
- •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
研究组 & 干预措施
Methylprednisolone, caustic burns
No Intervention
干预措施: methylprednisolon (Drug)
结局指标
主要结局
Evaluation of stricture development in children with caustic esophageal burns after high doses of methylprednisolone
时间窗: three years
stricture development was evaluated with endoscopic examination and upper gastrointestinal system series with barium swallow
次要结局
未报告次要终点
研究者
Merve Usta
DR
Sisli Hamidiye Etfal Training and Research Hospital
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