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

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://ichgcp.net/clinical-trials-registry/NCT03751475.

Keywords: clinical trials; community child health; nutrition; paediatric pathology; protocols and guidelines; public health.

Conflict of interest statement

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

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1

Schedule of enrolment, interventions and assessments OptiMA-DRC overview. *Monthly active screening in 60 villages and passive screening during outpatient visit in four health centres. **Weekly (for those living in villages at 14 km or less from the health centre) or bimonthly (for those living in villages more than 14 km from the health centre) outpatient visits at health centre for participants with ready-to-use therapeutic food (RUTF) supplementation. ***Bimonthly home visits for children without RUTF supplementation. d, day; DRC, Democratic Republic of Congo; m, month; OptiMA, optimising acute malnutrition.