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NCT06792370
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Conditions: Acute Malnutrition With no Complications
Sex: All
Ages: 6 Months – 59 Months
Healthy volunteers: No
Phase: NA
Enrollment: 3521
Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
Location: Institut de Recherche en Sciences de la Santé Ouagadougou KADIOGO
Summary
This experimental study aims to test an alternative protocol for managing acute malnutrition in children aged 6-59 months in Burkina Faso. This alternative protocol consists of using RUTF instead of RUSF for the management of moderate acute malnutrition and reduced-dose RUTF instead of standard-dose RUTF for the treatment of severe acute malnutrition.
The main questions are:
1. Does treating children with moderate acute malnutrition using RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with RUSF?
2. Does treating children with uncomplicated severe acute malnutrition using a reduced dose of RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with a standard dose of RUFT?
Secondly, the study will investigate the effect of this alternative protocol compared to the standard protocol on cost-effectiveness, psychomotor development, weight and linear growth and incidence of relapses.
Eligibility Criteria
1. MAM
Inclusion Criteria:
* Anthropometric measures:
* (115 mm ≤ MUAC\< 125 mm and -3 SDs ≤ WLZ \< -2 SDs) OR
* (115 mm ≤ MUAC\< 125 mm and WLZ ≥ -2 SDs) OR
* (MUAC ≥ 125 mm and -3 SDs ≤ WLZ \< -2 SDs).
* Age: 6 to 59 months
* Parents' acceptance of biweekly visits until programme discharge and monthly visits for the post-programme follow up
Exclusion Criteria:
* Failure of appetite test
* Medical complications requiring hospital treatment
* Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection
* Presence of bilateral oedema
* History of allergies to peanuts, milk, or soya
* Relapse from MAM treatment or transfer from SAM treatment
* Children who have recently (\
Source: ClinicalTrials.gov (NCT06792370). StuddyBuddy aggregates publicly available trial information.