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

简要总结

主要结局

次要结局

• Study ORS intake (units)(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)
• 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)
• Record patient use of antibiotics during hospitalization(up to 24 hours or hospital discharge, whichever comes first)
• Participant comfort questionaire(baseline and 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)
• Time ready for discharge(At discharge or 48 hours whichever occurs first)
• Frequency of liquid/watery stool(every 4 hours up to 24 hours or hospital discharge, whichever occurs first)
• Medically confirmed adverse events collected throughout the study period(0 hours through 7 days post discharge)
• Weight(Every 4 hours up to 24 h or at hospital discharge, whichever occurs first)
• Time to resolution of liquid/water stool(up to 24 hours or hospital discharge, whichever comes first)
• Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.)(Baseline)
• Stool for bacterial pathogen culture and viral antigens(up to 24 hours or hospital discharge, whichever comes first)