CTRI/2010/091/000080未知2/3 期
UTILITY OF HYPERTONIC SALINE IN MANAGEMENT OF ACUTE BRONCHIOLITIS IN INFANTS
Dr Neeraj Dhawan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 待定
适应症
试验速览
- 阶段
- 2/3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- length of hospital stay.
研究概览
简要总结
THIS STUDY IS A RANDOMIZED,DOUBLE-BLIND,CONTROLLED TRIAL TO STUDY THE EFFICACY AND SAFETY OF HYPERTONIC SALINE WITH ADRENALINE IN ACUTE BRONCHIOLITIS. THE PRIMARY OUTCOME IS THE LENGTH OF STAY IN HOSPITAL AND SECONDRY IS IMPROVEMENT IN RDAI SCORE, RESPIRATORY RATE, HAEMOGLOBIN SATURATION.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •Infants between the age group of two month to twelve months and admitted with clinical diagnosis of acute bronchiolitis.
排除标准
- •1.patient with recurrent episodes of wheezing, one or more episodes of respiratory distress in past2.patients with family history of asthma,atopy.3.presence of congenital heart disease.
- •history of prematurity and mechanical ventilation in newborn period.5.very sick patients with shock, seizures, heart rate>180/min,respiratory rate of >100/min and adjudged to be in incipient resp.
- •faliure.6.grade 3 and 4 PEM7.consolidation lung on x-ray chest.8.foreingn body aspiration.9.no child will be included in the study twice.
结局指标
主要结局
length of hospital stay.
次要结局
- 1.improvement in RDAI score.2. respiratory rate.3.haemoglobin saturation.4.heart rate.5.number of add on treatment.6.adverse events(tachycardia,pallor,tremor,nausea,vomiting)
研究者
研究点 (1)
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