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

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

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.

Study Overview

• Status: Terminated
• Conditions: Dehydration; Acute Gastroenteritis
• Intervention / Treatment: Other: Standard IV Rehydration Therapy; Other: Oral Rehydration Therapy (ORT)

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33155
      • Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard IV Rehydration Therapy; 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; IV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg); Other: Oral Rehydration Therapy (ORT); 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
Experimental: Oral Rehydration Therapy (ORT); Patients randomized into the oral rehydration group will receive the oral Speedlyte product instead of the IV rehydration therapy.	Other: Standard IV Rehydration Therapy; IV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg); Other: Oral Rehydration Therapy (ORT); 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to initiation of therapy	Time to initiation of therapy in each group	up to 24 hours
Number of patients that fail to rehydrate	Obtain the number of patients that fail to rehydrate in each group. Oral requiring IV intervention, IV requiring further fluids and/or admission.	up to 24 hours
Hospitalization rate	The rate of hospitalization for each group	up to 24 hours
Revisit rate in each group.	The revisit rate for each group	up to 24 hours

Collaborators and Investigators

• Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
• Collaborators: Einsoff Biohealth
• Investigators: Principal Investigator: Barbara Pena, MD, Nicklaus Children's Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): January 22, 2020
• Study Completion (Actual): January 22, 2020

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: diarrhea; vomiting
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Disease Attributes; Gastrointestinal Diseases; Water-Electrolyte Imbalance; Emergencies; Gastroenteritis; Dehydration
• Other Study ID Numbers: MCH09017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No