Acute infectious diarrhoea Infections and Infestations Infectious diarrhoea
Conditions
Interventions
Consecutive children presenting to the paediatric emergency room or outpatient clinics at CMC Hospital and CHAD, and fulfilling inclusion criteria, will be offered entry into the study. The admitting
children will be designated to treatment arms by the packet that they receive.
Treatment will be prepared and administered by study nurses. Standard ORS will be formulated according to WHO recommen
Sponsors
Christian Medical College (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age six months to three years with acute diarrhoea, defined as more than three episodes of watery stools in the last 24 hours 2. Clinically detectable dehydration to warrant hospital treatment
Exclusion criteria
Exclusion criteria: 1. Blood and mucus in stool 2. Severe coexisting disease, including pneumonia, meningitis, or severe (grades III and IV) malnutrition 3. Vomiting that precludes administration of oral rehydration solution 4. Children with severe dehydration who are still severely dehydrated after three to six hours of intravenous fluids as per WHO treatment plan C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diarrhoeal duration, defined as time from the start of ORS consumption to the last unformed stool, or the last stool prior to a 12 hour period without any bowel movement. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stool frequency 2. Diarrhoeal stool output measured by weight. This will be measured only in male children; due to anatomical considerations only male children can have urine collected separately in a urine pouch so that accurate stool weights collected can be measured in pre-weighed diapers 3. Proportion of children who recover from diarrhoea by 24 hours and 48 hours 4. The need for unscheduled intravenous hydration for recurrent severe dehydration 5. Adverse events | — |
Countries
India
Outcome results
None listed