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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 Kasai, 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://clinicaltrials.gov/ct2/show/NCT03751475.

SUBMITTER: Cazes C

PROVIDER: S-EPMC7713214 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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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.

Cazes Cécile C Phelan Kevin K Hubert Victoire V Alitanou Rodrigue R Boubacar Harouna H Izie Bozama Liévin L Tshibangu Sakubu Gilbert G Beuscart Aurélie A Yao Cyrille C Gabillard Delphine D Kinda Moumouni M Augier Augustin A Anglaret Xavier X Shepherd Susan S Becquet Renaud R

BMJ open 20201202 12

<h4>Introduction</h4>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 s ...[more]

PMID: 33268424

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Project description:BackgroundSimplified 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).MethodsA 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.DiscussionThis 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 registrationClinicalTrials.gov NCT04698070 . Registered on January 6, 2021.

Project description:The present study aimed to determine the 3-month incidence of relapse and associated factors among children who recovered under the Optimising treatment for acute MAlnutrition (OptiMA) strategy, a MUAC-based protocol. A prospective cohort of children successfully treated for acute malnutrition was monitored between April 2017 and February 2018. Children were seen at home by community health workers (CHWs) every 2 weeks for 3 months. Relapse was defined as a child who had met OptiMA recovery criteria (MUAC ≥ 125 mm for two consecutive weeks) but subsequently had a MUAC < 125 mm at any home visit. Cumulative incidence and incidence rates per 100 child-months were estimated. Multivariable survival analysis was conducted using a shared frailty model with a random effect on health facilities to identify associated factors. Of the 640 children included, the overall 3-month cumulative incidence of relapse was 6⋅8 % (95 % CI 5⋅2, 8⋅8). Globally, the incidence rate of relapse was 2⋅5 (95 % CI 1⋅9, 3⋅3) per 100 child-months and 3⋅7 (95 % CI 1⋅9, 6⋅8) per 100 child-months among children admitted with a MUAC < 115 mm. Most (88⋅6 %) relapses were detected early when MUAC was between 120 and 124 mm. Relapse was positively associated with hospitalisation, with an adjusted hazard ratio (aHR) of 2⋅06 (95 % CI 1⋅01, 4⋅26) for children who had an inpatient stay at any point during treatment compared with children who did not. The incidence of relapse following recovery under OptiMA was relatively low in this context, but the lack of a standard relapse definition does not allow for comparison across settings Closer follow-up with caretakers whose children are admitted with MUAC < 115 mm or required hospitalisation during treatment should be considered in managing groups at high risk of relapse. Training caretakers to screen their children for relapse at home using MUAC could be more effective at detecting early relapse, and less costly, than home visits by CHWs.

Project description:IntroductionHousehold contacts of cholera cases are at a greater risk of Vibrio cholerae infection than the general population. There is currently no agreed standard of care for household contacts, despite their high risk of infection, in cholera response strategies. In 2018, hygiene kit distribution and health promotion was recommended by Médecins Sans Frontières for admitted patients and accompanying household members on admission to a cholera treatment unit in the Democratic Republic of Congo.MethodsTo investigate the effectiveness of the intervention and risk factors for cholera infection, we conducted a prospective cohort study and followed household contacts for 7 days after patient admission. Clinical surveillance among household contacts was based on self-reported symptoms of cholera and diarrhoea, and environmental surveillance through the collection and analysis of food and water samples.ResultsFrom 94 eligible households, 469 household contacts were enrolled and 444 completed follow-up. Multivariate analysis suggested evidence of a dose-response relationship with increased kit use associated with decreased relative risk of suspected cholera: household contacts in the high kit-use group had a 66% lower incidence of suspected cholera (adjusted risk ratio (aRR) 0.34, 95% CI 0.11 to 1.03, p=0.055), the mid-use group had a 53% lower incidence (aRR 0.47, 95% CI 0.17 to 1.29, p=1.44) and low-use group had 22% lower incidence (aRR 0.78, 95% CI 0.24 to 2.53, p=0.684), compared with household contacts without a kit. Drinking water contamination was significantly reduced among households in receipt of a kit. There was no significant effect on self-reported diarrhoea or food contamination.ConclusionThe integration of a hygiene kit intervention to case-households may be effective in reducing cholera transmission among household contacts and environmental contamination within the household. Further work is required to evaluate whether other proactive localised distribution among patients and case-households or to households surrounding cholera cases can be used in future cholera response programmes in emergency contexts.

Project description:BackgroundCurrent standard management of severe acute malnutrition uses ready-to-use therapeutic food (RUTF) at a single weight-based calculation resulting in an increasing amount of RUTF provided to the family as the child's weight increases during recovery. Using RUTF at a gradually reduced dosage as the child recovers could reduce costs while achieving similar growth response.MethodsWe conducted an open-label, non-inferiority, randomised controlled trial in the Democratic Republic of the Congo. Children aged 6-59 months with a mid-upper-arm circumference (MUAC) of less than 115 mm or a weight-for-height z-score (WHZ) of less than -3 or bipedal oedema and without medical complication were randomly assigned (1:1 ratio) using a specially developed software and random blocks (size was kept confidential), to either the current standard treatment (increasing the RUTF amount with increasing weight) or the OptiMA strategy (decreasing the RUTF dose with increasing weight and MUAC). The main endpoint was proportion of children who achieved recovery over the 6 months follow up period, as defined as meeting the following criteria for two consecutive weeks after a minimum of 4 weeks' treatment: axillary temperature less than 37.5 °C, no bipedal oedema, and anthropometric improvement (either MUAC 125 mm or greater or WHZ -1.5 or higher). We performed analyses on the intention-to-treat (ITT) (all children) and per-protocol populations (participants who had a minimum prescription of 4 weeks' RUTF, received at least 90% of the total amount of RUTF they were supposed to receive as per the protocol, and had a maximum interval of 6 weeks between any two visits in the 6-month follow-up). The non-inferiority margin was 10%. This trial is registered at ClinicalTrials.gov, and is now closed NCT03751475.FindingsBetween July 22, 2019, and January 20, 2020, 491 children were randomly assigned, of whom 482 were analysed (240 in the standard group and 242 in the OptiMA group). In the ITT analysis, 234 (98%) children in the standard group and 231 (96%) children in OptiMA recovered (difference 2.0%, 95% CI -2.0% to 6.4%). In the PP analysis, 234 (98%) children in the standard group and 228 (97%) in OptiMA recovered (difference 1.3%, 95% CI -2.3% to 5.1%). Sensitivity analyses applying the same anthropometric recovery criteria to each group also showed non-inferiority of the OptiMA strategy in ITT and PP analysis.InterpretationThis non-inferiority trial treating uncomplicated children with MUAC of less than 115 mm or a WHZ of less than -3 or bipedal oedema with decreasing RUTF dose as MUAC and weight increase demonstrated non-inferiority compared to the standard protocol in a highly food-insecure context in the Democratic Republic of the Congo. These findings add evidence on the safety of RUTF dose reduction with significant RUTF cost savings.FundingInnocent Foundation and European Civil Protection and Humanitarian Aid Operations.TranslationFor the French translation of the abstract see Supplementary Materials section.

Project description:BackgroundKwashiorkor is an often-fatal type of severe acute malnutrition affecting hundreds of thousands of children annually, but whose etiology is still unknown. Evidence suggests inadequate sulfur amino acid (SAA) status may explain many signs of the condition but studies evaluating dietary protein intake in relation to the genesis of kwashiorkor have been conflicting. We know of no studies of kwashiorkor that have measured dietary SAAs.ObjectivesWe aimed to determine whether children in a population previously determined to have high prevalence of kwashiorkor [high-prevalence population (HPP)] have lower dietary intakes of SAAs than children in a low-prevalence population (LPP).MethodsA cross-sectional census survey design of 358 children compared 2 previously identified adjacent populations of children 36-59 mo old in North Kivu Province of the Democratic Republic of the Congo. Data collected included urinary thiocyanate (SCN), cyanogens in cassava-based food products, recent history of illness, and a 24-h quantitative diet recall for the child.ResultsThe HPP and LPP had kwashiorkor prevalence of 4.5% and 1.7%, respectively. A total of 170 children from 141 households in the LPP and 169 children from 138 households in the HPP completed the study. A higher proportion of HPP children had measurable urinary SCN (44.8% compared with 29.4%, P < 0.01). LPP children were less likely to have been ill recently (26.8% compared with 13.6%, P < 0.01). Median [IQR] intake of SAAs was 32.4 [22.9-49.3] mg/kg for the LPP and 29.6 [18.1-44.3] mg/kg for the HPP (P < 0.05). Methionine was the first limiting amino acid in both populations, with the highest risk of inadequate intake found among HPP children (35.1% compared with 23.6%, P < 0.05).ConclusionsChildren in a population with a higher prevalence of kwashiorkor have lower dietary intake of SAAs than children in a population with a lower prevalence. Trial interventions to reduce incidence of kwashiorkor should consider increasing SAA intake, paying particular attention to methionine.

Dataset Information

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 Kasai, Democratic Republic of Congo.

Publications

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.

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