NCT04677296已完成不适用
Clinical Trial to Compare the Efficacy and Safety of a Multiple Amino-acid Based ORS "VS002A" With the Standard WHO-ORS in the Management of Non-cholera Acute Watery Diarrhea in Infants and Young Children
Entrinsic Bioscience Inc.1 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2021年6月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Duration of diarrhea in hospital (hours)
研究概览
简要总结
Randomized double blinded clinical trial comparing amino acid based oral rehydration solution/medical food and glucose-based oral rehydration solution is infectious diarrhea in pediatric population
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)
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 6 months - 36 months,
- •Duration of diarrhea ≤48 hours,
- •Some dehydration (judged clinically according to the "Dhaka method"),
- •Written informed consent by either parent/guardian.
排除标准
- •Severe malnutrition (Weight-for-length WLZ/WHZ/WAZ <-3 or presence of nutritional edema)
- •Patients with diarrhea due to cholera.
- •Systemic illness (e.g. Pneumonia, tuberculosis, enteric fever, meningitis etc.)
- •Bloody diarrhea
- •Any congenital anomaly or disorder (e.g. diagnosed inborn error of metabolism, congenital cardiac disease, seizure disorders, hypothyroidism, Down's syndrome etc.)
- •Requirement of additional intravenous fluids after being provided with an IV for 4 hours on admission if severely dehydrated
- •Has documentation of taking antibiotic and/or antidiarrheal within the last 48 hours prior to hospitalization.
结局指标
主要结局
Duration of diarrhea in hospital (hours)
时间窗: 5 days
number of hours of diarrhea after randomization
次要结局
- Total urine output during hospitalization(5 days)
- Total ORS intake(5 days)
- Total stool output(5 days)
- Change in body weight (between pre-randomization and post-treatment)(5 days)
- ORS intake in the 1st 24 hours of hospitalization(1 day)
- Stool output(1 day)
- Documented infectious agent(5 days)
- Unscheduled IV (frequency/ORS group)(5 days)
- Treatment failure (frequency/ORS group)(5 days)
- Output and frequency of vomiting(5 days)
- Urine output in the 1st 24 hours of hospitalization (g/kg body wt.)(1 day)
研究者
研究点 (1)
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