DehydrationNCT03562702
Comparing Speedlyte and IV Rehydration Treating Children With Gastroenteritis in a Pediatric Emergency Department (ED)
A study testing Standard IV Rehydration Therapy and Oral Rehydration Therapy (ORT) in people with Dehydration and Acute Gastroenteritis, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Acute Gastroenteritis
- What is being tested?
- Standard IV Rehydration Therapy and Oral Rehydration Therapy (ORT)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 22 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Miami, Florida, 33155
About this study
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
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.
Read the 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
- Being tested
- Standard IV Rehydration Therapy, Oral Rehydration Therapy (ORT)
- Keywords
- vomiting, diarrhea
- Medical subject headings
- Dehydration, Vomiting, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard IV Rehydration TherapyOther
IV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg)
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Standard IV Rehydration Therapy; Other: Oral Rehydration Therapy (ORT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 hours
Secondary outcomes (1)
Adjunct Medication
Number of adjunct medications given in the ED in both groups
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Jul 2018
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Why it stopped: Access to Speedlyte Product no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Einsoff Biohealth
- Responsible party
- Sponsor
- Investigators
- Barbara Pena, MD, Principal investigator, Nicklaus Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562702
- Sponsor's protocol ID
- MCH09017
- Status last verified
- Jan 2020
- First submitted
- 19 Apr 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1186/1741-7015-2-11.
PubMed 15086953Spandorfer 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.
PubMed 15687435
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03562702
- Acronym / sponsor ID
- MCH09017
- Conditions
- Dehydration, Acute Gastroenteritis
- Keywords
- vomiting, diarrhea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Access to Speedlyte Product no longer available.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's HospitalUniversity, hospital or other
- Collaborators
- Einsoff Biohealth
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard IV Rehydration Therapy | Active comparator | Other: Standard IV Rehydration Therapy, Other: Oral Rehydration Therapy (ORT)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 |
| Oral Rehydration Therapy (ORT) | Experimental | Other: Standard IV Rehydration Therapy, Other: Oral Rehydration Therapy (ORT)Patients randomized into the oral rehydration group will receive the oral Speedlyte product instead of the IV rehydration therapy. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard IV Rehydration TherapyIV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg) | Other | Oral Rehydration Therapy (ORT), Standard IV Rehydration Therapy |
| 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 | Other | Oral Rehydration Therapy (ORT), Standard IV Rehydration Therapy |
Primary outcome
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.
1 secondary outcome
Adjunct Medication
Time frame: up to 24 hours
Results and safety
The study was stopped early (reason given: Access to Speedlyte Product no longer available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 15086953Bellemare 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.
- Background: PubMed 15687435Spandorfer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Pena, MD principal investigator
Nicklaus Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard IV Rehydration Therapy and Oral Rehydration Therapy (ORT) in people with Dehydration and Acute Gastroenteritis, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Access to Speedlyte Product no longer available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (LOS) (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562702, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020; AzTrials last refreshed its copy on 26 Oct 2026.