NCT01482208已完成不适用
Study of Ultrasonic Hydration Monitor for Neonatology and Pediatric Children and Infants and/or Children up to Age 3 Years Old With Diarrhea
Artann Laboratories1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2011年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Assess the ability of IHM to measure changes of hydration status ni newborn and infants
研究概览
简要总结
Study will verify ability of infant Hydration Monitor (IHM) to assess changes of hydration status in newborns and infants by means of ultrasound velocity measurements through muscle tissues. Changes of tissue hydration will be followed during first days of life in newborns and in acute diarrhea in small children during re-hydration therapy. Weighting and clinical dehydration symptoms will be used as controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns from 1 to 7 days old,
- •Health infants from 1 month to 3 years old,
- •Any ethnicity,
- •Male or female,
- •Infants with diarrhea,
- •Acute gastroenteritis,
- •Diarrhea and/or vomiting,
- •Suspected dehydration
排除标准
- •Congenital heart disease,
- •Renal failure,
- •Chronic liver disease,
- •Chronic lung disease,
- •Inflammatory bowel disease,
- •Immune deficiency,
- •Severe malnutrition,
- •Any external damage to skin of leg,
- •Infants and Children whose parents refuse permission to be included
结局指标
主要结局
Assess the ability of IHM to measure changes of hydration status ni newborn and infants
时间窗: 1 week to several months
Infants and small children diagnosed with diarrhea or presenting to the hopsital with diseases known to cause dehydration are eligible
次要结局
未报告次要终点
研究者
研究点 (1)
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