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Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a community-based individually randomised controlled trial in Kasaï, Democratic Republic of Congo
  1. Cécile Cazes1,
  2. Kevin Phelan2,
  3. Victoire Hubert3,
  4. Rodrigue Alitanou3,
  5. Harouna Boubacar3,
  6. Liévin Izie Bozama4,
  7. Gilbert Tshibangu Sakubu5,
  8. Aurélie Beuscart1,
  9. Cyrille Yao6,
  10. Delphine Gabillard1,
  11. Moumouni Kinda7,
  12. Augustin Augier2,
  13. Xavier Anglaret1,
  14. Susan Shepherd7,
  15. Renaud Becquet1
  1. 1University of Bordeaux, Inserm, French National Research Institute for Sustainable Development (IRD), Bordeaux Population Health Research Center, Team IDLIC, UMR 1219, Bordeaux, France
  2. 2The Alliance for International Medical Action (ALIMA), Paris, France
  3. 3The Alliance for International Medical Action (ALIMA), Kamuesha, Democratic Republic of Congo
  4. 4National Nutrition Programme (PRONANUT), Ministry of Health, Kinshasa, Democratic Republic of Congo
  5. 5Kamuesha Health Zone in the Kasaï Province, Ministry of Health, Kamuesha, Democratic Republic of Congo
  6. 6PACCI Research Programme, University Hospital of Treichville, Abidjan, Côte d'Ivoire
  7. 7The Alliance for International Medical Action (ALIMA), Dakar, Senegal
  1. Correspondence to Mrs Cécile Cazes; cecile.cazes{at}u-bordeaux.fr

Abstract

Introduction Acute malnutrition (AM) is a continuum condition, arbitrarily divided into moderate and severe AM (SAM) categories, funded and managed in separate programmes under different protocols. Optimising acute MAlnutrition (OptiMA) treatment aims to simplify and optimise AM management by treating children with mid-upper arm circumference (MUAC) <125 mm or oedema with one product—ready-to-use therapeutic food—at a gradually tapered dose. Our main objective was to compare the OptiMA strategy with the standard nutritional protocol in children 6–59 months presenting with MUAC <125 mm or oedema without additional complications, as well as in children classified as uncomplicated SAM (ie, MUAC <115 mm or weight-for-height Z-score (WHZ) <−3 or with oedema).

Methods and analysis This study was a non-inferiority, individually randomised controlled clinical trial conducted at community level in the Democratic Republic of Congo. Children 6–59 months presenting with MUAC <125 mm or WHZ <−3 or with bipedal oedema and without medical complication were included after signed informed consent in outpatient health facilities. All participants were followed for 6 months. Success in both arms was defined at 6 months post inclusion as being alive, not acutely malnourished per the definition applied at inclusion and without an additional episode of AM throughout the 6-month observation period. Recovery among children with uncomplicated SAM was the main secondary outcome. For the primary objective, 890 participants were needed, and 480 children with SAM were needed for the main secondary objective. We will perform non-inferiority analyses in per-protocol and intention-to-treat basis for both outcomes.

Ethics and dissemination Ethics approvals were obtained from the National Health Ethics Committee of the Democratic Republic of Congo and from the Ethics Evaluation Committee of Inserm, the French National Institute for Health and Medical Research (Paris, France). We will submit results for publication to a peer-reviewed journal and disseminate findings in international and national conferences and meetings.

Trial registration number NCT03751475. Registered 19 September 2018, https://clinicaltrials.gov/ct2/show/NCT03751475.

  • nutrition
  • public health
  • clinical trials
  • paediatric pathology
  • community child health
  • protocols and guidelines
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Footnotes

  • Contributors SS and RB developed the clinical (SS) and methodological (RB) study concept. RB, CC, XA, DG, AA, KP and SS designed the study methodology and wrote the protocol. CC, VH, HB, RA and MK coordinate the study teams. LIB, GTS coordinate the MoH staff working in the trial. CC, VH, HB, LIB, GTS, AB, CY and RB organise and supervise data collection. CY created the software tool for randomisation and developed the database. CC, VH, DG, XA, SS and RB developed the statistical analysis strategy. CC wrote the first draft of the manuscript. SS and RB were primarily responsible for the final content of the manuscript. All authors critically reviewed the first draft and had a substantial writing contribution to the development of the final manuscript.

  • Funding The study was supported by the Innocent Foundation (London, UK), grant number ALIMA-2018-DRC, and received additional funding from European Commission through the European Civil Protection and Humanitarian Aid Operations (ECHO, Brussels, Belgium), grant number ECHO/COD/BUD/2018/91023. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. This document covers humanitarian aid activities implemented with the financial assistance of the European Union. The views expressed herein should not be taken, in any way, to reflect the official opinion of the European Union, and the European Commission is not responsible for any use that can be made of the information it contains.

  • Competing interests KP serves on the Social Purposes Advisory Commission of Nutriset, a main producer of lipid-based nutrient supplement products.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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