- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01863394
Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children 6-59 Months in Mirria District, Niger (MàLÉ)
Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children Aged 6-59 Months in the Mirria District, Niger
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zinder
-
Mirria, Zinder, Niger
- Mirriah health district
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children aged 06-59 months at the time of the study
- children who live in a village in the health district participating in the study
Exclusion Criteria:
- children whose legal guardian refuses to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Screening by community health workers
One Community Health Worker (CHW) will be trained per village in the comparator arm. The training the CHWs receive will be identical to that delivered in the Community Management of Acute Malnutrition program run by ALIMA/BEFEN (Bien Être de la Femme et l'Enfant Niger) over the last 3 years. This involves 6 hours theoretical training and a practical session in the health centre. CHWs will screen children 06-59 months in their village once a month |
|
Experimental: Screening by mothers
Mothers in the intervention health district will be trained in small womens' groups in their village. Training will have a theoretical component and a practical demonstration component on children in the village During the first baseline door to door mass screening campaign, mothers will also receive individual training on conducting a Mid Upper Arm Circumference (MUAC) classification and looking for pedal oedema. they will receive a brief recap during the three monthly door-to-door mass screening campaigns Mothers will be asked to check their child's MUAC and look for pedal oedema
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The coverage of the therapeutic nutritional program in the control and intervention health districts
Time Frame: 12 months
|
Coverage of the the therapeutic nutritional treatment program is defined as the proportion of children 06-59 months with Severe Acute Malnutrition (Mid Upper Arm Circumference <115mm and/or oedema) receiving treatment in the program, amongst the total number of children diagnosed with Severe Acute Malnutrition
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Malnutrition program data for children referred by community health workers & mothers
Time Frame: 12 months
|
Nutritional status at admission (mid upper arm circumference +/- oedema) Type of admission to the programme (out-patient or immediate transfer for in-patient care) Source of reference to the programme (Community Health Worker, Mother, other) Date of discharge from the programme Weight at admission to the programme Discharge criteria (cured, died, failed to attend, non-response to treatment, transfer for in-patient nutrition care, transfer to other health care structures) Number of children screened by mothers confirmed to have SAM at the treatment centre Number of children screened by community health workers confirmed to have SAM at the treatment centre
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nikki BLACKWELL, FCICM, Alliance for International Medical Action
- Study Director: Isabelle Defourney, MBBS, Alliance for International Medical Action
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUAC À L'ÉCHELLE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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