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

NCT03562702 | Terminated

• 1 other identifier: MCH09017
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration; Acute Gastroenteritis

Keywords

vomiting; diarrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adjunct Medication

  up to 24 hours

Other Outcomes (4)

• Time to initiation of therapy

  up to 24 hours

• Number of patients that fail to rehydrate

  up to 24 hours

• Hospitalization rate

  up to 24 hours

Study Arms (2)

Standard IV Rehydration Therapy

ACTIVE COMPARATOR

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; Other: Oral Rehydration Therapy (ORT)

Oral Rehydration Therapy (ORT)

EXPERIMENTAL

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

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

Interventions

Standard IV Rehydration Therapy OTHER

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

Oral Rehydration Therapy (ORT); Standard IV Rehydration Therapy

Oral Rehydration Therapy (ORT) 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); Standard IV Rehydration Therapy

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicklaus Children's Hospital f/k/a Miami Children's Hospital: lead
• Einsoff Biohealth: collaborator

Study Sites (1)

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

Miami, Florida, 33155, United States

Location

Related Publications (2)

• 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.

  PMID: 15086953 BACKGROUND

• 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.

  PMID: 15687435 BACKGROUND

MeSH Terms

Conditions

Dehydration; Vomiting; Diarrhea

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Barbara Pena, MD

  Nicklaus Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: June 19, 2018
• Study Start: July 1, 2018
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)