Corticosteroids as an Additional Treatment for Mastoiditis In Children
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 主要终点
- Time from the beginning of the treatment until clinical and laboratory findings are within normal limits
研究概览
简要总结
The aim of the study is to assess the influence of adjuvant corticosteroid treatment in acute mastoiditis in children. we expect a better outcome in children treated with both corticosteroids and antibiotics including lower rates in complications and earlier decline in fever and inflammatory markers.
详细描述
The research is a multi-centered, prospective, placebo-control, randomized controlled trial. The study group will be comprised of children diagnosed with acute mastoiditis and hospitalized in a pediatric medical center.
The participating patients will be randomized divided into two groups. Research group will be given dexamethasone treatment (course of 16 doses, 0.15 mg/kg/dose every 6 hours) in addition to antibiotic treatment. Control group will be given 16 doses of 0.9% normal saline in addition to antibiotic treatment. Management and treatment will be conducted according to clinical condition and laboratory findings as for routine institution protocols. It should be noted that the regular institutional management of children enrolled for the study will not be changed due to our research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
participants will be randomized divided into two groups. each group will be given dexamethasone or 0.9% normal saline. only the pharmacist will not be masked to the procedure.
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •acute mastoiditis
排除标准
- •immunodeficiency (congenital or acquired)
- •significant chronic disease
- •hypertension
- •recurrent mastoiditis
研究组 & 干预措施
Placebo
participants will be given normal saline in addition to conventional treatment
干预措施: normal saline (Drug)
Experimental
participants will be given corticosteroids in addition to conventional treatment
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Time from the beginning of the treatment until clinical and laboratory findings are within normal limits
时间窗: during hospitalization, anticipated 1-2 weeks
fever, crp levels
次要结局
- Complication rates(during hospitalization, anticipated 1-2 weeks)
研究者
ori snapiri
Pediatrician, Principal Investigator, Clinical doctor
Rabin Medical Center