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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03562702
Recruitment Status : Terminated (Access to Speedlyte Product no longer available.)
First Posted : June 19, 2018
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Einsoff Biohealth
Information provided by (Responsible Party):
Nicklaus Children's Hospital f/k/a Miami Children's Hospital

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562702


Locations
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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
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Principal Investigator: Barbara Pena, MD Nicklaus Children's Hospital
Publications:
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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    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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