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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.

ABSTRACT: BACKGROUND:Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6-59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally. METHODS AND FINDINGS:A cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) < 11.5 cm and/or edema, and 1 sachet of RUTF per day for those with MUAC 11.5 to <12.5 cm. Standard care clinics treated SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF). The primary outcome was nutritional recovery. Secondary outcomes included cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains. Main analyses were per-protocol, with intention-to-treat analyses also conducted. The non-inferiority margin was 10%. From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male). In total, 1,286 (62.1%) and 1,202 (59.0%), respectively, completed treatment; 981 (76.3%) on the combined protocol and 884 (73.5%) on the standard protocol recovered, yielding a risk difference of 0.03 (95% CI -0.05 to 0.10, p = 0.52; per-protocol analysis, adjusted for country, age, and sex). The amount of ready-to-use food (RUTF or RUSF) required for a child with SAM to reach full recovery was less in the combined protocol (122 versus 193 sachets), and the combined protocol cost US$123 less per child recovered (US$918 versus US$1,041). There were 23 (1.8%) deaths in the combined protocol arm and 21 (1.8%) deaths in the standard protocol arm (adjusted risk difference 95% CI -0.01 to 0.01, p = 0.87). There was no evidence of a difference between the protocols for any of the other secondary outcomes. Study limitations included contextual factors leading to defaulting, a combined multi-country power estimate, and operational constraints. CONCLUSIONS:Combined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings). This trial is complete and registered at ISRCTN (ISRCTN30393230). TRIAL REGISTRATION:The trial is registered at ISRCTN, trial number ISRCTN30393230.

SUBMITTER: Bailey J

PROVIDER: S-EPMC7347103 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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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.

Bailey Jeanette J Opondo Charles C Lelijveld Natasha N Marron Bethany B Onyo Pamela P Musyoki Eunice N EN Adongo Susan W SW Manary Mark M Briend André A Kerac Marko M

PLoS medicine 20200709 7

<h4>Background</h4>Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6-59 months. Eliminating the need for separate products and protocols could improve the imp ...[more]

PMID: 32645109

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Project description:BackgroundIn many low income countries, the majority of acutely malnourished children are either brought to the health facility late or never at all due to reasons related to distance and associated costs. Integrated community case management (iCCM) is an integrated approach addressing disease and malnutrition through use of community health volunteers (CHVs) in children under-5 years. Evidence on the potential impact and practical experiences on integrating community-based management of acute malnutrition as part of an iCCM package is not well documented. In this study, we aim to investigate the effectiveness and cost effectiveness of integrating management of acute malnutrition into iCCM.MethodsThis is a two arm parallel groups, non-inferiority cluster randomized community trial (CRT) employing mixed methods approach (both qualitative and quantitative approaches). Baseline and end line data will be collected from eligible (malnourished) mother/caregiver-child dyads. Ten community units (CUs) with a cluster size of 24 study subjects will be randomized to either an intervention (5 CUs) and a control arm (5 CUs). CHV in the control arm, will only screening and refer MAM/SAM cases to the nearby health facility for treatment by healthcare professionals. In the intervention arm, however; CHVs will be trained both to screen/diagnose and also treat moderate acute malnutrition (MAM) and severe acute malnutrition (SAM) without complication. A paired-matching design where each control group will be matched with intervention group with similar characteristics will be matched to ensure balance between the two groups with respect to baseline characteristics. Qualitative data will be collected using key informant and in-depth interviews (KIIs) and focused group discussions (FGDs) to capture the views and experiences of stakeholders.DiscussionOur proposed intervention is based on an innovative approach of integrating and simplifying SAM and MAM management through CHWs bring the services closer to the community. The trial has received ethical approval from the Ethics Committee of AMREF Health Africa - Ethical and Scientific Review Committee (AMREF- ESRC), Nairobi, Kenya. The results will be disseminated through workshops, policy briefs, peer-reviewed publications, and presented to local and international conferences.Trial registrationPACTR201811870943127 ; Pre-results. 26 November 2018.

Project description:BACKGROUND:Acute malnutrition is currently divided into severe (SAM) and moderate (MAM) based on level of wasting. SAM and MAM currently have separate treatment protocols and products, managed by separate international agencies. For SAM, the dose of treatment is allocated by the child's weight. A combined and simplified protocol for SAM and MAM, with a standardised dose of ready-to-use therapeutic food (RUTF), is being trialled for non-inferior recovery rates and may be more cost-effective than the current standard protocols for treating SAM and MAM. METHOD:This is the protocol for the economic evaluation of the ComPAS trial, a cluster-randomised controlled, non-inferiority trial that compares a novel combined protocol for treating uncomplicated acute malnutrition compared to the current standard protocol in South Sudan and Kenya. We will calculate the total economic costs of both protocols from a societal perspective, using accounting data, interviews and survey questionnaires. The incremental cost of implementing the combined protocol will be estimated, and all costs and outcomes will be presented as a cost-consequence analysis. Incremental cost-effectiveness ratio will be calculated for primary and secondary outcome, if statistically significant. DISCUSSION:We hypothesise that implementing the combined protocol will be cost-effective due to streamlined logistics at clinic level, reduced length of treatment, especially for MAM, and reduced dosages of RUTF. The findings of this economic evaluation will be important for policymakers, especially given the hypothesised non-inferiority of the main health outcomes. The publication of this protocol aims to improve rigour of conduct and transparency of data collection and analysis. It is also intended to promote inclusion of economic evaluation in other nutrition intervention studies, especially for MAM, and improve comparability with other studies. TRIAL REGISTRATION:ISRCTN 30393230 , date: 16/03/2017.

Project description:IntroductionSevere and moderate acute malnutrition (SAM and MAM) affect more than 50 million children worldwide yet 80% of these children do not access care. The Combined Protocol for Acute Malnutrition Study (ComPAS) trial assessed the effectiveness of a simplified, combined SAM/MAM protocol for children aged 6-59 months and found non-inferior recovery compared to standard care. To further inform policy, this study assessed post-discharge outcomes of children treated with this novel protocol in Kenya.MethodsSix 'combined' protocol clinics treated SAM and MAM children using an optimised mid-upper arm circumference (MUAC)-based dose of ready-to-use therapeutic food (RUTF). Six 'standard care' clinics treated SAM with weight-based RUTF rations; MAM with ready-to-use supplementary food (RUSF). Four months post-discharge, we assessed anthropometry, recent history of illness, and body composition by bioelectrical impedance analysis. Data was analysed using multivariable linear regression, adjusted for age, sex and allowing for clustering by clinic.ResultsWe sampled 850 children (median age 18 months, IQR 15-23); 44% of the original trial sample in Kenya. Children treated with the combined protocol had similar anthropometry, fat-free mass, fat mass, skinfold thickness z-scores, and frequency of common illnesses 4 months post-discharge compared the standard protocol. Mean subscapular skinfold z-scores were close to the global norm (standard care: 0.24; combined 0.27). There was no significant difference in odds of relapse between protocols (SAM, 3% vs 3%, OR = 1.0 p = 0.75; MAM, 10% vs 12%, OR = 0.90 p = 0.34).ConclusionsDespite the lower dosage of RUTF for most SAM children in the combined protocol, their anthropometry and relapse rates at 4 months post-discharge were similar to standard care. MAM children treated with RUTF had similar body composition to those treated with RUSF and neither group exhibited excess adiposity. These results add further evidence that a combined protocol is as effective as standard care with no evidence of adverse effects post-discharge. A simplified, combined approach could treat more children, stretch existing resources further, and contribute to achieving Sustainable Development Goal Two.

Project description:BackgroundModerate acute malnutrition is a major public health problem affecting children from low- and middle-income countries. Lipid nutrient supplements have been proposed as a nutritional intervention for its treatment.ObjectivesTo evaluate the effectiveness and safety of LNS for the treatment of MAM in infants and children 6 to 59 months of age.Study designSystematic review of randomized-controlled trials and controlled before-after studies.ResultsData from nine trials showed that use of LNS, in comparison to specially formulated foods, improved the recovery rate (RR 1.08; 95% CI 1.02-1.14, 8 RCTs, 8934 participants, low quality evidence); decreased the chances of no recovery (RR 0.70; 95% CI 0.58-0.85, 7 RCTs, 8364 participants, low quality evidence) and the risk of deterioration into severe acute malnutrition (RR 0.87; 95% CI 0.73-1.03, 6 RCTs, 6788 participants, low quality evidence). There was little impact on mortality (RR 0.94, 95% CI 0.54-1.52, 8 RCTs, 8364 participants, very-low- quality evidence) or default rate (RR 1.32; 95% CI 0.73-2.4, 7 studies, 7570 participants, low quality evidence). There was improvement in weight gain, weight-for-height z-scores, height-for-age z-scores and mid-upper arm circumference. Subset analyses suggested higher recovery rates with greater amount of calories provided and with ready-to-use therapeutic foods, in comparison to ready-to-use supplementary foods. One study comparing LNS with nutritional counselling (very low quality evidence) showed higher chance of recovery, lower risk of deteriorating into severe acute malnutrition and lower default rate, with no impact on mortality, and no recovery.ConclusionsEvidence restricted to the African regions suggests that LNS may be slightly more effective than specially formulated fortified foods or nutritional counselling in recovery from MAM, lowering the risk of deterioration into SAM, and improving weight gain with little impact on mortality or default rate.

Dataset Information

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.

Publications

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.

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