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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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16 December 2017 |
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Main ID: |
NCT03044548 |
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Date of registration:
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20/12/2016 |
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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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Improving the Quality of Care for Children With Acute Malnutrition in Uganda
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Scientific title:
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Improving the Quality of Care for Children With Acute Malnutrition: Cluster Randomised Controlled Trial in West Nile Region, Uganda |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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700 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03044548 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Humphrey Wanzira, Msc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Marzia Lazzerini, PhD |
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Address:
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Telephone:
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Email:
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marzia.lazzerini@burlo.trieste.it |
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Affiliation:
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Name:
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Marzia Lazzerini, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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WHO CC |
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Key inclusion & exclusion criteria
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For the primary outcomes, the study sample will consists of children with malnutrition
treated at in health center (HC) in Arua district
Inclusion Criteria:
1. Children 6 months-5 years
2. Diagnosis of SAM or MAM according to National criteria (10) SAM: weight-for-height <-
3 standard deviation (SD) from the mean based on the WHO 2006 standards (11).
MAM: weight-for-height <- 2 and > -3 standard deviation (SD) from the mean based on the WHO
2006 growth reference standards .
Exclusion Criteria:
1. Not matching the above criteria for SAM and MAM
2. Refusal to participate/ consent
3. Unable to adhere to study follow up procedures
Age minimum:
6 Months
Age maximum:
60 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malnutrition, Child
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Intervention(s)
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Other: Supportive supervision
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Primary Outcome(s)
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Cure rate
[Time Frame: 12- 16 weeks]
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Secondary Outcome(s)
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Cost
[Time Frame: study start, than every month up to 15 months]
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Rate of Not cured
[Time Frame: 12- 16 weeks]
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Equity outcomes
[Time Frame: study start, than every month up to 15 months]
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Rate of defaulted
[Time Frame: 12- 16 weeks]
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Rate of transferred to ITC (inpatient treatment center)
[Time Frame: 12- 16 weeks]
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Staff satisfaction score
[Time Frame: study start, month 6 and month 15]
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Dead rate
[Time Frame: 12- 16 weeks]
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Quality of data
[Time Frame: study start, than every month up to 15 months]
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Rate of transferred to OTC (outpatient treatment center)
[Time Frame: 12- 16 weeks]
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Secondary ID(s)
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Prot 521/2016
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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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