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临床试验/NCT05517499
NCT05517499已完成不适用

Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

Services Institute of Medical Sciences, Pakistan1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
The number of days required for ventilation in participants

研究概览

简要总结

Objective: To determine efficacy of dexamethasone in treatment of meconium aspiration syndrome.

Study design: Randomized control trial. Place and duration: Services hospital, Neonatal unit, Lahore. During time span of 1st January to 30th June 2021.

Material and methods Total 100 neonates were randomly divided in two groups. Group A (n=50) was treated with dexamethasone (Cases) and Group B (n=50) served as control. Dexamethasone was given in dose of 0.2mg/kg, 12 hourly for 7 days after confirmation of diagnosis. Infants present in clinical trial were evaluated by ventilation duration (invasive and non-invasive), oxygen therapy and hospital stay.

详细描述

Data was analyzed in statistical analysis SPSS version 23. Means and Standard deviation were calculated for duration of non-invasive and invasive ventilation, hospital stay and oxygen therapy. Independent sample T test was applied and value < 0.05 was taken as significant. Whereas frequency and percentages were taken for gender, gestation, mode of delivery and outcome of MAS and Chi-square test was applied, and p value < 0.05 was taken as significant.

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
None

入排标准

年龄范围
— 至 24 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Term and Post-Term babies who met the operational definition of MAS (inborn)
  • Presenting within 24 hours of life

排除标准

  • Preterm babies or babies with congenital malformations
  • Preterm babies or babies with dysmorphism
  • Preterm babies or babies with hypoxic-ischemic encephalopathy

研究组 & 干预措施

Group A (Dexamethasone Group),

Experimental

Group A (Case Group) was given dexamethasone i.e., 0.2 mg per kg per day every 12 hours for 7 days intravenously. All treatment strategies were same in both groups but steroid was given to group A

干预措施: Dexamethasone (Drug)

结局指标

主要结局

The number of days required for ventilation in participants

时间窗: 7 days

The purpose of study was to measure number of days required for ventilation in participants

The number of days required for oxygen therapy in participants

时间窗: 7 days

The purpose of study was to measure number of days required for oxygen therapy in participants

The number of days required for hospitalization in participants

时间窗: 7 days

The purpose of study was to measure number of days required for hospitalization in participants

次要结局

未报告次要终点

研究者

发起方
Services Institute of Medical Sciences, Pakistan
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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