Status:
COMPLETED
Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond
Lead Sponsor:
Action Contre la Faim
Collaborating Sponsors:
Duke University
University Ghent
Conditions:
Severe Acute Malnutrition
Eligibility:
All Genders
6-5 years
Brief Summary
INTRODUCTION In 2014, 50 million children under 5 suffered from acute malnutrition, of which 16 million suffered from SAM, most of them living in sub-Saharan Africa and Southeast Asia. SAM children h...
Detailed Description
DIAGNOSTIC DISCREPANCY According to WHO experts, WHZ and MUAC can be used independently to indicate severe acute malnutrition (WH. There is however a significant and sometimes huge discrepancy betwee...
Eligibility Criteria
Inclusion
- Diagnosed SAM and eligible for CMAM treatment, defined as: (1) WHZ \< -3 and/or MUAC \< 115 mm; (2) No bilateral pitting edema; (3) Children without the general danger signs of illness as per the Integrated Management of Childhood Illness (IMCI) guidelines like lethargy, unconsciousness, convulsions or severe vomiting (WHO 2005).
- Resident of the catchment area at the time of inclusion; and
- Caretakers consent for the child to participate.
Exclusion
- Plans to leave the catchment area within the next 6 months;
- Known peanut and/or milk allergy;
- Admitted for SAM treatment within the past 6 months prior to recruitment (including re-admission after default, relapse or medical transfer);
- Malformations which may affect food intake such as cleft palate, cerebral palsy, Down's syndrome; and,
- The presence of general danger signs as per the IMCI guidelines.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 25 2018
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT03400930
Start Date
January 1 2017
End Date
April 25 2018
Last Update
July 5 2019
Active Locations (3)
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1
Action Against Hunger, Bangladesh
Cox’s Bāzār, Chittagong, Bangladesh, 4700
2
Action Contre la Faim, Burkina Faso
Fada N'gourma, Région de l'Est, Burkina Faso
3
Action Against Hunger, Liberia
Monrovia, Montserrado County, Liberia, 1000