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This is a randomised, controlled, open-label study to determine the clinical effectiveness and safety of a novel ORS compared with a commercial ORS in children 1 to 5 years of age attending emergency departments with gastroenteritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Commercial reduced-osmolarity oral rehydration solution (ORS | Active Comparator |
| |
| VS011, new children's ORS, a sugar-free blend of amino acids and electrolytes | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose containing Oral Rehydration Solution (ORS) | Dietary Supplement | Oral rehydration solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically assessed adequate rehydration based on clinical judgement of change in or absence of presenting symptoms from baseline (i.e. heart rate, urine output, etc.) | Assess change in clinical hydration status from presenting baseline status | every 4 hours up to 24 hours or hospital discharge, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.) | 5 point scale, 1(no discomfort) minimum, 5 (severe discomfort) maximum | Baseline |
| Study ORS intake (units) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramathibodi Hospital | Bangkok | Thailand | ||||
| Siriraj Hospital |
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| Sugar free - amino acid and electrolyte ORS | Dietary Supplement | Glucose free oral rehydration solution |
|
| Every 4 hours up to 24 hours or hospital discharge, whichever occurs first |
| Use of IV fluids | up to 24 hours or hospital discharge, whichever occurs first |
| Weight | kg | Every 4 hours up to 24 h or at hospital discharge, whichever occurs first |
| Participant comfort questionaire | baseline and 24 hours or hospital discharge, whichever occurs first |
| Parent satisfaction questionnaire | baseline and 24 hours or hospital discharge, whichever occurs first |
| Frequency of vomiting | every 4 hours up to 24 hours or hospital discharge, whichever occurs first |
| Frequency episodes of urination | every 4 hours up to 24 hours or hospital discharge, whichever occurs first |
| Frequency of liquid/watery stool | every 4 hours up to 24 hours or hospital discharge, whichever occurs first |
| Time to resolution of liquid/water stool | up to 24 hours or hospital discharge, whichever comes first |
| Stool for bacterial pathogen culture and viral antigens | up to 24 hours or hospital discharge, whichever comes first |
| Time ready for discharge | At discharge or 48 hours whichever occurs first |
| Medically confirmed adverse events collected throughout the study period | 0 hours through 7 days post discharge |
| Record patient use of antibiotics during hospitalization | up to 24 hours or hospital discharge, whichever comes first |
| Bangkok |
| Thailand |
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | Thailand |
| Naresuan University Hospital | Phitsanulok | Thailand |