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

• ClinicalTrials.gov Identifier: NCT03562702
• Recruitment Status: Terminated
• First Posted: June 19, 2018
• Last Update Posted: January 27, 2020
• Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
• Collaborator: Einsoff Biohealth
• Information provided by (Responsible Party): Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dehydration; Acute Gastroenteritis	Other: Standard IV Rehydration Therapy; Other: Oral Rehydration Therapy (ORT)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: 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.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: July 1, 2018
• Actual Primary Completion Date: January 22, 2020
• Actual Study Completion Date: January 22, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Length of stay (LOS) [ Time Frame: 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.

Secondary Outcome Measures :

1. Adjunct Medication [ Time Frame: up to 24 hours ]
   Number of adjunct medications given in the ED in both groups

Other Outcome Measures:

1. Time to initiation of therapy [ Time Frame: up to 24 hours ]
   Time to initiation of therapy in each group
2. Number of patients that fail to rehydrate [ Time Frame: up to 24 hours ]
   Obtain the number of patients that fail to rehydrate in each group. Oral requiring IV intervention, IV requiring further fluids and/or admission.
3. Hospitalization rate [ Time Frame: up to 24 hours ]
   The rate of hospitalization for each group
4. Revisit rate in each group. [ Time Frame: up to 24 hours ]
   The revisit rate for each group

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

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

Miami, Florida, United States, 33155

Sponsors and Collaborators

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

Einsoff Biohealth

Investigators

• Principal Investigator: Barbara Pena, MD; Nicklaus Children's Hospital

More Information

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.

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.

• Responsible Party: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
• ClinicalTrials.gov Identifier: NCT03562702
• Other Study ID Numbers: MCH09017
• First Posted: June 19, 2018
• Last Update Posted: January 27, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nicklaus Children's Hospital f/k/a Miami Children's Hospital:

vomiting; diarrhea

Additional relevant MeSH terms:

Gastroenteritis; Dehydration; Emergencies; Disease Attributes; Pathologic Processes; Gastrointestinal Diseases; Digestive System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases