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Maternal, Perinatal and Pediatric Nutrition (Poster Session)

(P10-083-24) Optimizing Management of Uncomplicated Acute Malnutrition in Children Aged 6 to 59 Months: A 3 Arms Community-Based Individually Randomized Controlled Trial in Rural Niger

Sunday, June 30, 2024
11:45 AM – 12:45 PM CT
Location: Poster Board 578

    Presenting Author(s)

  • KP

    Kevin Phelan, MSc

    Senior Nutrition Advisor
    ALIMA
    PARIS, Ile-de-France, France

    • Co-Author(s)

  • MA

    Mahamadou Aboubacar

    Commission for the Initiative “les Nigériens Nourrissent les Nigériens” (HC3N), Niger

  • SA

    Sanoussi Atte

    Nutrition Directorate, Ministry of Health, Niger

  • JA

    Jean-Claude Azani

    PACCI Research Programme, University Hospital of Treichville, Cote d'Ivoire (Ivory Coast)

  • RB

    Renaud Becquet, PhD, HDR

    Principal investigator, researcher
    University of Bordeaux, Inserm, French National Research Institute for Sustainable Development (IRD), Bordeaux Population Health Research Center, Team IDLIC, UMR 1219, France
    Bordeaux, Aquitaine, France

  • HB

    Harouna Boubacar, Nurse

    Clinical trial monitor
    The Alliance for International Medical Action (ALIMA), Kamuesha, Democratic Republic of Congo
    Kamuesha, Kasai-Occidental, Congo, (Congo – Kinshasa)

  • JH

    Jérémie Hien

    The Alliance for International Medical Action (ALIMA), Niger

  • SK

    Suvi Kangas

    International Rescue Committee (IRC), Senegal

  • SS

    Susan Shepherd, MD

    Principal investigator, medical director
    The Alliance for International Medical Action (ALIMA), Dakar, Senegal
    Dakar, Dakar, Senegal

  • MD

    Maguy Daures

    University of Bordeaux, Fench National Institute for Health and Medical Research (Inserm), French National Research Institute for Sustainable Development (IRD), Bordeaux Population Health Research Center, Team GHiGS, UMR 1219, France

Disclosure(s):
Kevin Phelan, MSc: Nutriset: Independent Contractor (including contracted research) (Ongoing)


Objectives: Optimising treatment for Acute Malnutrition (OptiMA) and the Combined Protocol for Acute malnutrition Study (ComPAS) aim to simplify processes and improve efficiency in acute malnutrition (AM) programming. More evidence is needed for such approaches in West Africa, specifically among children admitted with Mid-upper arm circumference (MUAC) < 115mm.

Methods: This individually randomised, non-inferiority 3-arm trial was conducted in Mirriah, Niger in 2021-22. Children 6–59 months with uncomplicated AM defined as MUAC < 125mm or oedema were randomized and followed for 6 months. The primary outcome compared the proportion of children successfully treated for AM, alive and without relapse over the 6-month period n OptiMA and ComPAS strategies to the Nigerien National Protocol. The secondary outcome compared recovery rate in children with MUAC < 115mm or oedema defined as: minimum of 4-weeks treatment, clinically well, MUAC >=125 mm without oedema for two weeks. Non-inferiority was shown if the upper-bound of the 95% CI of the difference between outcome proportions was less than 10% in both intention-to-treat (ITT) and per-protocol (PP) analyses.

Results: A total of 1732 children with AM and 1140 with MUAC < 115mm or oedema were randomised. For the primary outcome, 52.9% children in control arm, 49.7% in OptiMA (difference control vs OptiMA: 3.2, 97.5% CI -3.3-9.9) and 51.9% in ComPAS (difference control vs ComPAS: 1.0, 97.5% CI -5.5-7.6) had a favorable outcome. In PP analysis, non-inferiority was not shown. There was no difference between the 3 arms in nutritional and vital status at study conclusion. For the secondary outcome, recovery rates in OptiMA and ComPAS were inferior to control arm while they were associated with missed clinic visits. Growth trajectories were similar for ComPAS but, were lower for OptiMA while the ration was reduced by 50% and 31%, respectively.

Conclusions: Even if non inferiority was not demonstrated for the main outcomes, this study adds evidence that dose reduction does not appear to cause harm as measured by growth trajectory, while 40% more children could be treated without increased ready-to-use therapeutic food (RUTF) cost.

Funding Sources: Research for Health in Humanitarian crises (UK), the Givewell Foundation (USA), and the European Civil Protection and Humanitarian Aid Operations (Belgium).