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临床试验/NCT03562702
NCT03562702终止不适用

Comparative Study Between the Oral Rehydration Product, Speedlyte, With Lipophilic Absorption and IV Rehydration in Treatment of Children With Gastroenteritis in a Pediatric Emergency Department

Nicklaus Children's Hospital f/k/a Miami Children's Hospital2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
5
试验地点
2
主要终点
Length of stay (LOS)

研究概览

简要总结

To compare length of stay (LOS) of pediatric patients in a pediatric emergency room presenting with Gastroenteritis treated with IV rehydration versus oral Speedlyte rehydration.

详细描述

Gastroenteritis leading to dehydration is very commonly encountered in the pediatric emergency room setting. Oral rehydration therapy (ORT) is the first line therapy recommended by the American Academy of Pediatrics but is seldom used compared to intravenous therapy (IVT). ORT has many advantages including less traumatic to the patient, can be administered by mouth, can be administered at home and less costly compared to IVT. Furthermore, intravenous fluids may present several complications with IV placement such as infiltration, hematoma, air embolism, phlebitis, extravascular injection, intraarterial injection, etc. Speedlyte is a new oral rehydration product with lipophilic absorption which allows for electrolytes to be more readily absorbed compared to other oral rehydration solutions. The liposome encapsulates the salty molecules which is thought to decrease the negative salty taste associated with oral rehydration solutions. In addition, the encapsulation of electrolytes allows for more molecules to be delivered past the stomach acids and absorbed into the body under higher bioavailability due to the lipid shell.

Participants will be randomized into two rehydration groups. One group will receive oral rehydration with the Speedlyte product, the amount will be based on the participant's weight. The other group will receive intravenous rehydration with a normal saline bolus per physician practice, usually in the amount of 20 mL/kg. These interventions can be incorporated into the emergency room practice without undue expense to the setting or placing excessive demands on nursing time as these practices are standard of care in many rehydration cases.

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)

盲法说明

The assignment of treatment will be concealed from research team members involved in recruiting patients by using sealed, sequentially numbered, opaque envelopes containing the type of rehydration treatment to be used.

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 6 mths to 18 years;
  • Signs and symptoms of dehydration for less than a week
  • Diagnosis of acute gastroenteritis, dehydration, vomiting, and/or diarrhea;
  • Patient able to drink from bottle and/or cup;
  • Per clinician's judgment, patient needs rehydration with IV solution.

排除标准

  • Chronic disease that includes but not limited to TB, HIV, congenital heart disease with hemodynamic consequences, metabolic disease, cerebral palsy, adrenal hyperplasia, renal tubular acidosis, and nephropathy;
  • Vomiting due to head trauma;
  • Severe hydration;
  • Diabetic ketoacidosis;
  • Bloody diarrhea;
  • Diarrhea for more than a week;
  • Malnutrition;
  • Pneumonia;
  • Meningitis;
  • History of seizures;
  • Absent bowel sounds;
  • Not able to drink from bottle or cup;
  • Previous allergic reaction to citrate or other food coloring particles/formulation;
  • Parent/legal guardian refusing to participate.

结局指标

主要结局

Length of stay (LOS)

时间窗: up to 24 hours

Comparison of length of stay (LOS) in a pediatric emergency department in the treatment of acute gastroenteritis between the oral rehydration solution Speedlyte and intravenous rehydration.

次要结局

  • Adjunct Medication(up to 24 hours)

研究者

发起方
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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