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

NCT ID: NCT03562702

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-01-22

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.

Conditions

Dehydration; Acute Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Standard IV Rehydration Therapy

Intervention Type: OTHER

IV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg)

Oral Rehydration Therapy (ORT)

Intervention Type: OTHER

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

Oral Rehydration Therapy (ORT)

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

Group Type: EXPERIMENTAL

Standard IV Rehydration Therapy

Intervention Type: OTHER

IV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg)

Oral Rehydration Therapy (ORT)

Intervention Type: OTHER

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

Interventions

Standard IV Rehydration Therapy

IV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg)

Intervention Type: 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Einsoff Biohealth

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Pena, MD

Role: PRINCIPAL_INVESTIGATOR

Nicklaus Children's Hospital

Locations

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

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15086953 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15687435 (View on PubMed)

Other Identifiers

MCH09017

Identifier Type: -

Identifier Source: org_study_id