Comparing Speedlyte and IV Rehydration Treating Children With Gastroenteritis in a Pediatric Emergency Department (ED)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Dehydration, Acute Gastroenteritis

Intervention / Treatment
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* Other: Standard IV Rehydration Therapy
* Other: Oral Rehydration Therapy (ORT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; Burns; 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard IV Rehydration Therapy<br>Patients randomized into the IV rehydration group will receive a Normal Saline bolus of IVF (usually 20 mL/kg) which is the standard therapy up to 24 hrs or as needed depending on patient's weight | Other: Standard IV Rehydration Therapy<br>* IV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg)<br>Other: Oral Rehydration Therapy (ORT)<br>* Speedlyte oral solution as rehydration therapy based on participant's weight (10 m/l kg over one hour). Total of 150 ml/kg over 24 hours prior to discharge<br>|
| Experimental: Oral Rehydration Therapy (ORT)<br>Patients randomized into the oral rehydration group will receive the oral Speedlyte product instead of the IV rehydration therapy. | Other: Standard IV Rehydration Therapy<br>* IV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg)<br>Other: Oral Rehydration Therapy (ORT)<br>* Speedlyte oral solution as rehydration therapy based on participant's weight (10 m/l kg over one hour). Total of 150 ml/kg over 24 hours prior to discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay (LOS) | 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. | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjunct Medication | Number of adjunct medications given in the ED in both groups | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vomiting, diarrhea