Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?
|ClinicalTrials.gov Identifier: NCT01185054|
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : May 27, 2015
|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|
|Primary Completion Date :||May 2015|
|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 ]
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|