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临床试验/NCT00689312
NCT00689312已完成3 期

Palatability of Oral Rehydration Solutions

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
66
试验地点
1
主要终点
Mean taste scores for Pedialyte, Pediatric Electrolyte, and Enfalyte.

研究概览

简要总结

The primary objective of this study is to compare the mean taste scores for three fruit flavored oral rehydration solutions in children aged 5-10 years old. The secondary objective is to compare the proportions of children who indicate a taste preference for one of the solutions.

详细描述

In Canada, acute gastroenteritis remains a major cause of morbidity and hospitalizations. This, in large part, is due to an inability to realize the full benefits of oral rehydration therapy. Because oral rehydration solutions have a salty taste, many mild to moderate dehydrated children refuse to drink them. This has resulted in pediatricians recommending inappropriate solutions and the unnecessary administration of intravenous fluids. Although two meta-analyses have concluded that rice-based ORS (Enfalyte) is as or more effective than traditional ORS in reducing stool output, the palatability of different oral rehydration solutions have never been evaluated.

This will be the first prospective trial comparing the palatability of the most commonly recommended oral rehydration solutions, Pedialyte and Enfalyte with a newer solution, Pediatric Electrolyte. Both Pedialyte and Pediatric Electrolyte contain sucralose, dextrose, and fructose while Enfalyte contains rice syrup solids. Although the latter is as, or more effective than Pedialyte in reducing stool output, palatability may limit its use. Taste is important as children with gastroenteritis are frequently nauseated and may refuse to drink or vomit when consuming less palatable solutions.

We hypothesize that, compared to children who receive a rice-based ORS (Enfalyte), those who receive a sucralose ORS (Pediatric Electrolyte or Pedialyte) will report a higher mean taste score, will prefer to drink the sucralose sweetened ORS if they had to consume a larger volume, and are more likely to drink the entire volume they are provided.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 5-10 years of age evaluated in The Hospital for Sick Children's emergency department

排除标准

  • Children with diarrhea, a vomiting or diarrhea episode within 24 hours, head trauma, abdominal pain, upper respiratory symptoms, or nil per os status
  • Patients with gastrointestinal symptoms

研究组 & 干预措施

3

Experimental

干预措施: Pedialyte (Drug)

1

Active Comparator

干预措施: Enfalyte (Drug)

2

Experimental

干预措施: Pediatric Electrolyte (Drug)

结局指标

主要结局

Mean taste scores for Pedialyte, Pediatric Electrolyte, and Enfalyte.

时间窗: Immediately following consumption of each solution.

次要结局

  • Proportions of children who indicate a taste preference for one of the solutions.(Immediately following consumption of each solution.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Freedman

Adjunct Scientist

The Hospital for Sick Children

研究点 (1)

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