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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02216708 |
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Date of registration:
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13/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Slow Versus Rapid Rehydration of Severely Malnourished Children
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Scientific title:
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Comparison of Rapid and Slow Rehydration of Severely Malnourished Children Suffering From Dehydrating Diarrhoea and Impact on Renal Function and Subsequent Growth of Children |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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208 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02216708 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Bangladesh
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. History of acute watery diarrhoea of <24 hours.
2. Either sex.
3. Severe dehydration according to WHO guidelines
4. Wt for length/wt for age < -3 SD of WHO growth standard with or without
oedema.(malnutrition)
5. Consent given by the parents or legal guardian
Exclusion Criteria:
1. Bloody diarrhoea.
2. Severe infection (e.g. severe pneumonia, clinical sepsis, septic shock, meningitis).
3. Those who received antibiotics/antimicrobial for the current illness
Age minimum:
6 Months
Age maximum:
36 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diarrhea
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Intervention(s)
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Other: Rapid dehydration
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Other: Slow rehydration
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Primary Outcome(s)
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Proportion of patient with ORS failure/ requirement of unscheduled IV therapy
[Time Frame: 7 days]
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Incidence of over- hydration
[Time Frame: 7 days]
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Secondary Outcome(s)
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Proportion of patient with acidosis and increased serum creatinine after 24 hours
[Time Frame: 7 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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