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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.

ABSTRACT: The Optimising treatment for acute MAlnutrition (OptiMA) strategy trains mothers to use mid upper arm circumference (MUAC) bracelets for screening and targets treatment to children with MUAC < 125 mm or oedema with one therapeutic food at a gradually reduced dose. This study seeks to determine whether OptiMA conforms to SPHERE standards (recovery rate > 75 %). A single-arm proof-of-concept trial was conducted in 2017 in Yako district, Burkina Faso including children aged 6-59 months in outpatient health centres with MUAC < 125 mm or oedema. Outcomes were stratified by MUAC category at admission. Multivariate survival analysis was carried out to identify variables predictive of recovery. Among 4958 children included, 824 (16·6 %) were admitted with MUAC < 115 mm or oedema, 1070 (21·6 %) with MUAC 115-119 mm and 3064 (61·8 %) with MUAC 120-124 mm. The new dosage was correctly implemented at all visits for 75·9 % of children. Global recovery was 86·3 (95 % CI 85·4, 87·2) % and 70·5 (95 % CI 67·5, 73·5) % for children admitted with MUAC < 115 mm or oedema. Average therapeutic food consumption was 60·8 sachets per child treated. Recovery was positively associated with mothers trained to use MUAC prior to child's admission (adjusted hazard ratio 1·09; 95 % CI 1·01, 1·19). OptiMA was successfully implemented at the scale of an entire district under 'real-life' conditions. Programme outcomes exceeded SPHERE standards, but further study is needed to determine if increasing therapeutic food dosages for the most severely malnourished will improve recovery.

SUBMITTER: Daures M

PROVIDER: S-EPMC7054246 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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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.

Daures Maguy M Phelan Kevin K Issoufou Mariama M Kouanda Séni S Sawadogo Ousmane O Issaley Kader K Cazes Cecile C Séri Benjamin B Ouaro Bertine B Akpakpo Bruno B Mendiboure Vincent V Shepherd Susan S Becquet Renaud R

The British journal of nutrition 20191210 7

The Optimising treatment for acute MAlnutrition (OptiMA) strategy trains mothers to use mid upper arm circumference (MUAC) bracelets for screening and targets treatment to children with MUAC < 125 mm or oedema with one therapeutic food at a gradually reduced dose. This study seeks to determine whether OptiMA conforms to SPHERE standards (recovery rate > 75 %). A single-arm proof-of-concept trial was conducted in 2017 in Yako district, Burkina Faso including children aged 6-59 months in outpatien ...[more]

PMID: 31818335

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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: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:IntroductionAcute 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 analysisThis 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 disseminationEthics 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 numberNCT03751475. Registered 19 September 2018, https://clinicaltrials.gov/ct2/show/NCT03751475.

Project description:BackgroundThis methodological article is based on a health policy research project conducted in Burkina Faso (West Africa). Concept mapping (CM) was used as a research method to understand the local views of equity among stakeholders, who were concerned by the health policy under consideration. While this technique has been used in North America and elsewhere, to our knowledge it has not yet been applied in Africa in any vernacular language. Its application raises many issues and certain methodological limitations. Our objective in this article is to present its use in this particular context, and to share a number of methodological observations on the subject.MethodsTwo CMs were done among two different groups of local stakeholders following four steps: generating ideas, structuring the ideas, computing maps using multidimensional scaling and cluster analysis methods, and interpreting maps. Fifteen nurses were invited to take part in the study, all of whom had undergone training on health policies. Of these, nine nurses (60%) ultimately attended the two-day meeting, conducted in French. Of 45 members of village health committees who attended training on health policies, only eight were literate in the local language (Moore). Seven of these (88%) came to the meeting.ResultsThe local perception of equity seems close to the egalitarian model. The actors are not ready to compromise social stability and peace for the benefit of the worst-off. The discussion on the methodological limitations of CM raises the limitations of asking a single question in Moore and the challenge of translating a concept as complex as equity. While the translation of equity into Moore undoubtedly oriented the discussions toward social relations, we believe that, in the context of this study, the open-ended question concerning social justice has a threefold relevance. At the same time, those limitations were transformed into strengths. We understand that it was essential to resort to the focus group approach to explore deeply a complex subject such as equity, which became, after the two CMs, one of the important topics of the research.ConclusionUsing this technique in a new context was not the easiest thing to do. Nevertheless, contrary to what local organizers thought when we explained to them this "crazy" idea of applying the technique in Moore with peasants, we believe we have shown that it was feasible, even with persons not literate in French.

Project description:BackgroundMechanical labour induction with a transcervical balloon is as effective as pharmacological methods, with fewer adverse effects. Its use has been limited to labour induction with an unfavourable cervix able to retain the balloon. We have developed an innovative approach using 2-3 balloons side-by-side to extend the benefits of mechanical labour induction/augmentation with a favourable cervix without having to resort to amniotomy or uterotonics.ObjectivesTo assess the effectiveness of side-by-side balloons for extended labour induction/augmentation.MethodsWe conducted a single arm proof of concept trial at Princess Marina Hospital (PMH) in Gaborone, Botswana. Participants were assessed as unsuitable for single balloon labour induction based on a modified Bishop cervical score of 7 or more. Three Foley catheters taped symmetrically side by side were passed through the cervix and inflated with 60mls each. Traction was applied with a weight of 250mls water suspended over the bed-end. The use of uterotonics, time from induction to birth, mode of birth, Apgar scores and adverse maternal and neonatal outcomes were recorded. Participants' satisfaction with the method of labour induction was assessed using a descriptive scale.ResultsWe enrolled 20 participants of whom two were nulliparous. Indications for labour induction were mainly late term (70%) and hypertensive disorders of pregnancy (25%). The mean cervical score was 7.2. Overall, 17 (85%) of the participants achieved a vaginal birth, of whom 5 required oxytocin for labour augmentation. Four of these had requested removal of the balloons, one due to discomfort and three felt the process was taking too long. Three participants underwent caesarean birth. The mean time from initiation of labour induction to vaginal birth was 16 h (standard deviation (SD) 8.4) and 20 h for caesarean birth (SD 10.5). There were no 5-minute Apgar scores below 7 nor neonatal admissions. One baby required brief resuscitation. There were no adverse maternal outcomes.ConclusionThis proof-of-concept study suggests that use of side-by-side balloons in participants with favourable cervix is effective in achieving vaginal birth in most participants without uterotonics or amniotomy. There were no adverse outcomes, though the study was too small to exclude the possibility of rare adverse outcomes. This offers a novel option for labour induction/augmentation, particularly where uterotonics or amniotomy are best avoided such as prior caesarean birth, vertical infection transmission risk and in settings with limited capacity for fetal surveillance. The results clearly justify larger randomized trials to evaluate this novel approach with greater precision. On the basis of the current study we are developing a purpose-designed balloon for extended balloon labour induction.

Dataset Information

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.

Publications

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.

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