Clinical trial NCT03562702: Comparing Speedlyte and IV Rehydration Treating Children With Gastroenteritis in a Pediatric Emergency Department (ED)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dehydration
Acute Gastroenteritis
Keywords: vomiting
diarrhea
Lead sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Sponsor class: OTHER
Collaborators: name: Einsoff Biohealth
First posted: 2018-06-19
Enrollment: 5
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of stay (LOS)
timeFrame: up to 24 hours
Secondary outcomes:
measure: Adjunct Medication
timeFrame: up to 24 hours
Other outcomes:
measure: Time to initiation of therapy
timeFrame: up to 24 hours
measure: Number of patients that fail to rehydrate
timeFrame: up to 24 hours
measure: Hospitalization rate
timeFrame: up to 24 hours
measure: Revisit rate in each group.
timeFrame: up to 24 hours
Locations:
city: Miami
country: United States
facility: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
state: Florida
Study officials:
affiliation: Nicklaus Children's Hospital
name: Barbara Pena, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellemare S, Hartling L, Wiebe N, Russell K, Craig WR, McConnell D, Klassen TP. Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials. BMC Med. 2004 Apr 15;2:11. doi: 10.1186/1741-7015-2-11.
citation: Spandorfer PR, Alessandrini EA, Joffe MD, Localio R, Shaw KN. Oral versus intravenous rehydration of moderately dehydrated children: a randomized, controlled trial. Pediatrics. 2005 Feb;115(2):295-301. doi: 10.1542/peds.2004-0245.