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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01863394
Other study ID # MUAC À L'ÉCHELLE
Secondary ID
Status Completed
Phase N/A
First received May 7, 2013
Last updated July 14, 2014
Start date May 2013
Est. completion date April 2014

Study information

Verified date July 2014
Source Alliance for International Medical Action
Contact n/a
Is FDA regulated No
Health authority Niger: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine the efficacity of a community strategy for screening children 06-59 months old for Severe Acute Malnutrition (SAM) conducted by their mothers' compared with a community screening strategy conducted by Community Health Workers.


Recruitment information / eligibility

Status Completed
Enrollment 4429
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 59 Months
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Screening by mothers

Active comparator: Screening by community health workers


Locations

Country Name City State
Niger Mirriah health district Mirria Zinder

Sponsors (2)

Lead Sponsor Collaborator
Alliance for International Medical Action European Commission

Country where clinical trial is conducted

Niger, 

Outcome

Type Measure Description Time frame Safety issue
Primary The coverage of the therapeutic nutritional program in the control and intervention health districts 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 No
Secondary Malnutrition program data for children referred by community health workers & mothers 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 No
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