Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?
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|ClinicalTrials.gov Identifier: NCT01185054|
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastroenteritis||Other: ½ strength apple juice Other: Pediatric Electrolyte||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||624 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Experimental: Fluids as Tolerated (FAT) Group
The FAT group will receive ½ strength apple juice and will form the experimental group in this study.
Other: ½ strength apple juice
For each episode of diarrhea 10 ml/kg of fluid will be given and for each episode of vomiting 2 ml/kg will be given. If the child does not like the solution another fluid can be used.
Active Comparator: Electrolyte Maintenance Solution (EMS)
The EMS group will form the control group as solutions such as Pediatric Electrolyte® are routinely recommended for use in children with gastroenteritis.
Other: Pediatric Electrolyte
For each episode of diarrhea 10 ml/kg of fluid will be given and for each episode of vomiting 2 ml/kg will be given. If the child does not like the solution another electrolyte maintenance fluid can be used. Fluids containing non-physiological concentrations of glucose and electrolytes (carbonated drinks, sweetened fruit juices, water) will be discouraged.
Other Name: Oral Electrolyte Maintenance Solution
- Proportion of children experiencing a treatment failure [ Time Frame: Within 7 days of enrolment ]
This outcome will be deemed to have occurred if any of the following occur:
- Requires an unscheduled visit after the initial encounter
- Requires physician evaluation during a follow-up assessment.
- Hospitalization or Intravenous Rehydration
- Extended Symptomatology
- Failure to consume sufficient study fluid during the initial ED visit
- Percent Weight Change [ Time Frame: 72-84 hours after enrolment ]
- Proportion of Subjects Receiving Intravenous Rehydration [ Time Frame: 7 days ]
- Proportion of Subjects Requiring Hospitalization [ Time Frame: 7 days ]
- Frequency of diarrhea and vomiting episodes [ Time Frame: 7 days ]
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): NCT01185054
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Stephen Freedman, MD||The Hospital for Sick Children, Toronto Canada|