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

Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Status: Terminated

Conditions: Acute Gastroenteritis; Dehydration

Treatments: Other: Oral Rehydration Therapy (ORT); Other: Standard IV Rehydration Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03562702

MCH09017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5 participants in 2 patient groups

Standard IV Rehydration Therapy

Active Comparator group

Description:

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

Treatment:

Other: Oral Rehydration Therapy (ORT)

Other: Standard IV Rehydration Therapy

Oral Rehydration Therapy (ORT)

Experimental group

Description:

Patients randomized into the oral rehydration group will receive the oral Speedlyte product instead of the IV rehydration therapy.

Treatment:

Other: Oral Rehydration Therapy (ORT)

Other: Standard IV Rehydration Therapy