Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a 3 arms community-based individually randomised controlled trial in decentralised Niger
Maguy Daures, Jérémie Hien, Kevin Phelan, Harouna Boubacar, Sanoussi Atté, Mahamadou Aboubacar, Ahmad A G M Aly, Baweye Mayoum, Jean-Claude Azani, Jean-Jacques Koffi, Benjamin Séri, Aurélie Beuscart, Delphine Gabillard, Victoire Hubert, Cécile Cazes, Moumouni Kinda, Xavier Anglaret, Suvi Kangas, Susan Shepherd, Renaud Becquet, Maguy Daures, Jérémie Hien, Kevin Phelan, Harouna Boubacar, Sanoussi Atté, Mahamadou Aboubacar, Ahmad A G M Aly, Baweye Mayoum, Jean-Claude Azani, Jean-Jacques Koffi, Benjamin Séri, Aurélie Beuscart, Delphine Gabillard, Victoire Hubert, Cécile Cazes, Moumouni Kinda, Xavier Anglaret, Suvi Kangas, Susan Shepherd, Renaud Becquet
Abstract
Background: Simplified approaches of acute malnutrition (AM) treatment have been conducted over the past 5 years intending to unify processes and increase coverage among children aged 6 to 59 months without medical complication. The Optimsing treatment for Acute Malnutrition (OptiMA) and the Combined Protocol for Acute Malnutrition Study (ComPAS) are mid-upper arm circumference (MUAC)-based approaches treating children with MUAC < 125 mm or oedema with one sole product-ready-to-use therapeutic food-at a gradually tapered doses. This trial aims to compare the OptiMA and ComPAS strategies to the standard nutritional protocol of Niger assessed by a favourable outcome in the treatment of uncomplicated AM at 6 months post-randomisation and in terms of recovery rate after treatment of uncomplicated SAM (WHZ < - 3 or MUAC < 115mm or oedema) and among the most vulnerable children (MUAC < 115mm or oedema).
Methods: A non-inferiority individually randomised controlled clinical trial was conducted at the primary health centres level and in the community in the Zinder region in Niger in March 2021. Participants are children aged 6-59 months attending outpatient health centres with MUAC < 125mm or oedema without medical complications. All participants are followed for 6 months. Simplified strategies propose a gradual reduction of RUTF according to MUAC and weight in OptiMA and MUAC only in ComPAS. Favourable outcome is compositely defined at 6 months post-inclusion as being alive, not acutely malnourished by the definition applied at inclusion and without any additional episode of AM throughout the 6-month observation period. Recovery is defined throughout the 6 months post-randomisation by a minimum of 4-week duration of treatment, an axillary temperature < 37.5°C, an absence of bipedal oedema and a MUAC ≥ 125 mm for two consecutive weeks. The sample size calculation required 567 children per arm for the main objective, 295 and 384 children per arm for the secondary objectives among SAM and MUAC < 115 mm children, respectively. Per-protocol and intention-to-treat analyses will be conducted for each outcome.
Discussion: This trial is intending to generate much-needed evidence on various simplified and optimised AM treatment approaches and to participate in reaching a consensus on such nutrition protocols.
Trial registration: ClinicalTrials.gov NCT04698070 . Registered on January 6, 2021.
Conflict of interest statement
K.P. serves on the Social Purposes Advisory Commission of Nutriset, the main producer of lipid-based nutrient supplement products. The other authors declare that they have no competing interests.
© 2022. The Author(s).
References
- Levels and trends in child malnutrition: UNICEF/WHO/The World Bank Group joint child malnutrition estimates: key findings of the 2021 edition [Internet]. [cited 2021 Dec 9]. Available from: . Accessed 5 May 2021.
- Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet Lond Engl. 2013;382(9890):427–451. doi: 10.1016/S0140-6736(13)60937-X.
- Introduction aux Approches de traitement simplifiée à travers la gamme des types de malnutrition aiguë [Internet]. État de la malnutrition aiguë. [cited 2021 Dec 9]. Available from:
- Isanaka S, Andersen CT, Hanson KE, Berthé F, Grais RF, Briend A. Energy needs in the treatment of uncomplicated severe acute malnutrition: secondary analysis to optimize delivery of ready-to-use therapeutic foods. Matern Child Nutr. 2020;16(4):e12989. doi: 10.1111/mcn.12989.
- Binns P, Dale N, Hoq M, Banda C, Myatt M. Relationship between mid upper arm circumference and weight changes in children aged 6-59 months. Arch Public Health Arch Belg Sante Publique. 2015;73(1):54. doi: 10.1186/s13690-015-0103-y.
- État de la malnutrition aiguë. Pays [Internet]. État de la malnutrition aiguë. [cited 2021 Dec 9]. Available from:
- Chase RP, Kerac M, Grant A, Manary M, Briend A, Opondo C, Bailey J. Acute malnutrition recovery energy requirements based on mid-upper arm circumference: secondary analysis of feeding program data from 5 countries, Combined Protocol for Acute Malnutrition Study (ComPAS) stage 1. PloS One. 2020;15(6):e0230452. doi: 10.1371/journal.pone.0230452.
- Simplified-Aproaches-Rapid-Evidence-Review.pdf [Internet]. [cited 2021 Dec 9]. Available from:
- Maust A, Koroma AS, Abla C, Molokwu N, Ryan KN, Singh L, Manary MJ. Severe and moderate acute malnutrition can be successfully managed with an integrated protocol in Sierra Leone. J Nutr. 2015;145(11):2604–2609. doi: 10.3945/jn.115.214957.
- Daures M, Phelan K, Issoufou M, Kouanda S, Sawadogo O, Issaley K, Cazes C, Séri B, Ouaro B, Akpakpo B, Mendiboure V, Shepherd S, Becquet R. New approach to simplifying and optimising acute malnutrition treatment in children aged 6-59 months: the OptiMA single-arm proof-of-concept trial in Burkina Faso. Br J Nutr. 2020;123(7):756–767. doi: 10.1017/S0007114519003258.
- Cazes C, Phelan K, Hubert V, Alitanou R, Boubacar H, Izie Bozama L, Tshibangu Sakubu G, Beuscart A, Yao C, Gabillard D, Kinda M, Augier A, Anglaret X, Shepherd S, Becquet R. 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. BMJ Open. 2020;10(12):e041213. doi: 10.1136/bmjopen-2020-041213.
- Bailey J, Lelijveld N, Marron B, Onyoo P, Ho LS, Manary M, Briend A, Opondo C, Kerac M. Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: study protocol for a randomized controlled trial. Trials. 2018;19(1):251. doi: 10.1186/s13063-018-2643-2.
- Bailey J, Opondo C, Lelijveld N, Marron B, Onyo P, Musyoki EN, Adongo SW, Manary M, Briend A, Kerac M. A simplified, combined protocol versus standard treatment for acute malnutrition in children 6-59 months (ComPAS trial): a cluster-randomized controlled non-inferiority trial in Kenya and South Sudan. PLoS Med. 2020;17(7):e1003192. doi: 10.1371/journal.pmed.1003192.
- WHO | Community-based management of severe acute malnutrition [Internet]. WHO. World Health Organization; [cited 2021 Dec 9]. Available from:
- Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
- RAPPORT_SMART_Niger_2020_VF.pdf [Internet]. [cited 2021 Dec 9]. Available from: . Accessed Oct 2020.
- Jouan-Flahault C, Casset-Semanaz F, Minini P. Du bon usage des tests dans les essays cliniques. médecine/sciences [Internet]. 2004;20(2):231–5 Available from: . Accessed Feb 2004.
- Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340(mar23 1):c869. doi: 10.1136/bmj.c869.
Source: PubMed