Clinical trial NCT05247879: Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution
Official title: Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution in Children Ages 1-5 Years Presenting to Hospital With Mild or Moderate Dehydration Gastroenteritis: Randomized, Open-label, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroenteritis Acute
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 1 to 5 years of age, inclusive at randomization
* Hospitalized with mild to moderate dehydration due to ongoing diarrhea
* Signed informed consent obtained for child's participation in the study

Exclusion Criteria:

* Severe dehydration and/or use of IV fluids for current hospitalization
* Experiencing bloody diarrhea or diarrhea due to Cholera, Dysentery, persistent/chronic diarrhea, diarrhea with severe malnutrition, diarrhea associated with recent antibiotic use
* In the opinion of the Investigator, not suitable for treatment with ORS
* Have any underlying disease or disorder that may, in the opinion of the Investigator, affect the results of the study if they were enrolled (includes, but is not limited to, gastrointestinal disorders such as Crohn's disease or other inflammatory bowel disease or congenital malabsorption disorders)
* Cause of the dehydration is something other than diarrhea
* Known to be allergic to any of the components of the Investigational ORS

Primary outcomes:
measure: 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.)
timeFrame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Secondary outcomes:
measure: Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.)
timeFrame: Baseline
measure: Study ORS intake (units)
timeFrame: Every 4 hours up to 24 hours or hospital discharge, whichever occurs first
measure: Use of IV fluids
timeFrame: up to 24 hours or hospital discharge, whichever occurs first
measure: Weight
timeFrame: Every 4 hours up to 24 h or at hospital discharge, whichever occurs first
measure: Participant comfort questionaire
timeFrame: baseline and 24 hours or hospital discharge, whichever occurs first
measure: Parent satisfaction questionnaire
timeFrame: baseline and 24 hours or hospital discharge, whichever occurs first
measure: Frequency of vomiting
timeFrame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
measure: Frequency episodes of urination
timeFrame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
measure: Frequency of liquid/watery stool
timeFrame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
measure: Time to resolution of liquid/water stool
timeFrame: up to 24 hours or hospital discharge, whichever comes first
measure: Stool for bacterial pathogen culture and viral antigens
timeFrame: up to 24 hours or hospital discharge, whichever comes first
measure: Time ready for discharge
timeFrame: At discharge or 48 hours whichever occurs first
measure: Medically confirmed adverse events collected throughout the study period
timeFrame: 0 hours through 7 days post discharge
measure: Record patient use of antibiotics during hospitalization
timeFrame: up to 24 hours or hospital discharge, whichever comes first
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Phitsanulok
country: Thailand
facility: Naresuan University Hospital
Study officials:
References: