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

Dehydration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03562702
• Other study ID #: MCH09017
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: January 22, 2020

Study information

• Verified date: January 2020
• Source: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Dehydration
• Emergencies
• Gastroenteritis

Intervention

Other:
• Standard IV Rehydration Therapy
IV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg)
• 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

Locations

Country	Name	City	State
United States	Nicklaus Children's Hospital f/k/a Miami Children's Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nicklaus Children's Hospital f/k/a Miami Children's Hospital	Einsoff Biohealth

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to initiation of therapy	Time to initiation of therapy in each group	up to 24 hours
Other	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
Other	Hospitalization rate	The rate of hospitalization for each group	up to 24 hours
Other	Revisit rate in each group.	The revisit rate for each group	up to 24 hours
Primary	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	Adjunct Medication	Number of adjunct medications given in the ED in both groups	up to 24 hours