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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Oral rehydration solution
Glucose free oral rehydration solution
Ramathibodi Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Naresuan University Hospital
Phitsanulok, Thailand
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
Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
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
Time frame: Baseline
Study ORS intake (units)
Time frame: Every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Use of IV fluids
Time frame: up to 24 hours or hospital discharge, whichever occurs first
Weight
kg
Time frame: Every 4 hours up to 24 h or at hospital discharge, whichever occurs first
Participant comfort questionaire
Time frame: baseline and 24 hours or hospital discharge, whichever occurs first
Parent satisfaction questionnaire
Time frame: baseline and 24 hours or hospital discharge, whichever occurs first
Frequency of vomiting
Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Frequency episodes of urination
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Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Frequency of liquid/watery stool
Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Time to resolution of liquid/water stool
Time frame: up to 24 hours or hospital discharge, whichever comes first
Stool for bacterial pathogen culture and viral antigens
Time frame: up to 24 hours or hospital discharge, whichever comes first
Time ready for discharge
Time frame: At discharge or 48 hours whichever occurs first
Medically confirmed adverse events collected throughout the study period
Time frame: 0 hours through 7 days post discharge
Record patient use of antibiotics during hospitalization
Time frame: up to 24 hours or hospital discharge, whichever comes first