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Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition

RecruitingNAAges 6 Months - 59 MonthsAllInstitut de Recherche en Sciences de la Sante, Bu…
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In plain words

What the trial is, and whether it could suit you

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-e

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📋 Eligibility rules (as published)
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 (\<2 months) taken part in a nutrition programme; * Residence outside the study area * Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.) 2. SAM Inclusion Criteria: * Anthropometric measures MUAC\< 115 mm or WLZ\< - 3 SDs; * Age: 6-59 months; * Parents' acceptance of weekly 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 (\<2 months) taken part in a nutrition programme; * Residence outside the study area; * Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)
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What it tests

  • ready-to-use therapeutic food (for children with MAM)
  • Ready-to-use supplementary food
  • Ready to Use Therapeutic Food - Reduced dose 1
  • Ready to Use Therapeutic Food - Standard dose
  • Ready to Use Therapeutic Food - Reduced dose 2
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Where

1 site
Institut de Recherche en Sciences de la Santé
Ouagadougou, Burkina Faso
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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