CTRI/2013/02/003399招募中3 期
A randomized controlled trial to compare the safety and efficacy of low osmolarity ORS versus modified Rehydration Solution for Malnourished children (RESOMAL) for treatment of children with severe acute malnutrition and diarrhea
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of children who develop hyponatremia. (serum sodium less than 135 mmol/litre)
研究概览
简要总结
A randomizedcontrolled trial to compare the safety and efficacy of low osmolarity ORSversus modified Rehydration Solution forMalnourished children (RESOMAL) for treatment of children with severe acutemalnutrition and diarrhea conducted in Kalawati saran children hospital, New Delhi , India. the primary outcome measure will be incidence of hyponatremia at 0,12,24,48 hrs.Secondary outcome measures will be incidenceof hypokalemia, stool frequency and stool output in both the groups during 48 hours, episodes of vomiting in both the groups, incidence of fluid overload.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Month(s) 至 59.00 Month(s)(—)
- 性别
- All
入选标准
- •Children having acute diarrhea(of <14 days) with Severe Acute Malnutrition Severe Acute Malnutrition defined as weight for height < -3 SD per WHO growth charts and or bilateral pedal edema.
排除标准
- •Child received I/V fluid before admission Child with shock Child with convulsion or any other life threatening complication Child with known renal or heart disease History of not passed urine for more than 6 hours Electrolyte disturbance requring I/V correction.
结局指标
主要结局
Number of children who develop hyponatremia. (serum sodium less than 135 mmol/litre)
时间窗: 48 hours
次要结局
- Incidence of hypokalemia(48 hours)
- Stool frequency(48 hours)
- Episodes of vomiting(48 hours)
- Incidence of fluid overload(48hrs)
研究者
研究点 (1)
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