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1.
BMJ Open ; 14(6): e084997, 2024 Jun 23.
Artículo en Inglés | MEDLINE | ID: mdl-38910007

RESUMEN

INTRODUCTION: Biological disease-modifying antirheumatic drugs (bDMARDs) have revolutionised the treatment of inflammatory arthritis (IA). However, many people with IA still require planned orthopaedic surgery to reduce pain and improve function. Currently, bDMARDs are withheld during the perioperative period due to potential infection risk. However, this predisposes patients to IA flares and loss of disease control. The question of whether to stop or continue bDMARDs in the perioperative period has not been adequately addressed in a randomised controlled trial (RCT). METHODS AND ANALYSIS: PERISCOPE is a multicentre, superiority, pragmatic RCT investigating the stoppage or continuation of bDMARDs. Participants will be assigned 1:1 to either stop or continue their bDMARDs during the perioperative period. We aim to recruit 394 adult participants with IA. Potential participants will be identified in secondary care hospitals in the UK, screened by a delegated clinician. If eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported PROMIS-29 (Patient Reported Outcome Measurement Information System) over the first 12 weeks postsurgery. Secondary outcome measures are as follows: PROMIS - Health Assessment Questionnaire (PROMIS-HAQ), EQ-5D-5L, Disease activity: generic global Numeric Rating Scale (patient and clinician), Self-Administered Patient Satisfaction scale, Health care resource use and costs, Medication use, Surgical site infection, delayed wound healing, Adverse events (including systemic infections) and disease-specific outcomes (according to IA diagnosis). The costs associated with stopping and continuing bDMARDs will be assessed. A qualitative study will explore the patients' and clinicians' acceptability and experience of continuation/stoppage of bDMARDs in the perioperative period and the impact postoperatively. ETHICS AND DISSEMINATION: Ethical approval for this study was received from the West of Scotland Research Ethics Committee on 25 April 2023 (REC Ref: 23/WS/0049). The findings from PERISCOPE will be submitted to peer-reviewed journals and feed directly into practice guidelines for the use of bDMARDs in the perioperative period. TRIAL REGISTRATION NUMBER: ISRCTN17691638.


Asunto(s)
Antirreumáticos , Procedimientos Ortopédicos , Ensayos Clínicos Pragmáticos como Asunto , Humanos , Reino Unido , Antirreumáticos/uso terapéutico , Antirreumáticos/economía , Atención Perioperativa/métodos , Atención Perioperativa/economía , Investigación Cualitativa , Estudios Multicéntricos como Asunto , Proyectos Piloto , Análisis Costo-Beneficio , Productos Biológicos/uso terapéutico , Productos Biológicos/economía
3.
Front Public Health ; 11: 1199036, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37475774

RESUMEN

Introduction: Globally, access to treatment for severe and moderate acute malnutrition is very low, in part because different protocols and products are used in separate programs. New approaches, defining acute malnutrition (AM) as mid-upper arm circumference (MUAC) < 125 mm or oedema, are being investigated to compare effectiveness to current programs. Optimizing Malnutrition treatment (OptiMA) is one such strategy that treats AM with one product - ready-to-use therapeutic food, or RUTF - at reduced dosage as the child improves. Methods: This study aimed to determine whether OptiMA achieved effectiveness benchmarks established in the Nigerien National Nutrition protocol. A prospective cohort study of children in the rural Mirriah district evaluated outcomes among children 6-59 months with uncomplicated AM treated under OptiMA. In a parallel, unconnected program in one of the two trial sites, all non-malnourished children 6-23 months of age were provided small quantity lipid-based nutritional supplements (SQ-LNS). A multivariate logistic regression identified factors associated with hospitalization. Results: From July-December 2019, 1,105 children were included for analysis. Prior to treatment, 39.3% of children received SQ-LNS. Recovery, non-response, and mortality rates were 82.3%, 12.6%, and 0.7%, respectively, and the hospitalization rate was 15.1%. Children who received SQ-LNS before an episode of AM were 43% less likely to be hospitalized (ORa=0.57; 0.39-0.85, p = 0.004). Discussion: OptiMA had acceptable recovery compared to the Nigerien reference but non-response was high. Children who received SQ-LNS before treatment under OptiMA were less likely to be hospitalized, showing potential health benefits of combining simplified treatment protocols with food-based prevention in an area with a high burden of malnutrition such as rural Niger.


Asunto(s)
Desnutrición , Humanos , Niño , Niger , Estudios Prospectivos , Desnutrición/terapia , Resultado del Tratamiento , Suplementos Dietéticos , Estudios Observacionales como Asunto
4.
J Pediatr ; 262: 113609, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37419241

RESUMEN

OBJECTIVE: To evaluate the validity of the Responses to Illness Severity Quantification (RISQ) score to discriminate illness severity and transitions between levels of care during hospitalization. STUDY DESIGN: A prospective observational study conducted in Maiduguri, Nigeria, enrolled inpatients aged 1-59 months with severe acute malnutrition. The primary outcome was the RISQ score associated with the patient state. Heart and respiratory rate, oxygen saturation, respiratory effort, oxygen use, temperature, and level of consciousness are summed to calculate the RISQ score. Five states were defined by levels of care and hospital discharge outcome. The states were classified hierarchically, reflecting illness severity: hospital mortality was the most severe state, then intensive care unit (ICU), care in the stabilization phase (SP), care in the rehabilitation phase (RP), and lowest severity, survival at hospital discharge. A multistate statistical model examined performance of the RISQ score in predicting clinical states and transitions. RESULTS: Of 903 children enrolled (mean age, 14.6 months), 63 (7%) died. Mean RISQ scores during care in each phase were 3.5 (n = 2265) in the ICU, 1.7 (n = 6301) in the SP, and 1.5 (n = 2377) in the RP. Mean scores and HRs for a 3-point change in score at transitions: ICU to death, 6.9 (HR, 1.80); SP to ICU, 2.8 (HR, 2.00); ICU to SP, 2.0 (HR, 0.5); and RP to discharge, 1.4 (HR, 0.91). CONCLUSIONS: The RISQ score can discriminate between points of escalation or de-escalation of care and reflects illness severity in hospitalized children with severe acute malnutrition. Evaluation of clinical implementation and demonstration of benefit will be important before widespread adoption.


Asunto(s)
Niño Hospitalizado , Desnutrición Aguda Severa , Niño , Humanos , Lactante , Transferencia de Pacientes , Nigeria , Unidades de Cuidados Intensivos , Índice de Severidad de la Enfermedad , Gravedad del Paciente , Desnutrición Aguda Severa/diagnóstico , Desnutrición Aguda Severa/terapia
5.
EClinicalMedicine ; 58: 101878, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-36915287

RESUMEN

Background: Current 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. Methods: We 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. Findings: Between 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. Interpretation: This 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. Funding: Innocent Foundation and European Civil Protection and Humanitarian Aid Operations. Translation: For the French translation of the abstract see Supplementary Materials section.

7.
Acta Paediatr ; 111(9): 1752-1763, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35582782

RESUMEN

AIM: To develop and perform an initial validation of a score to measure the severity of illness in hospitalised children with severe acute malnutrition (SAM). METHODS: A prospective study enrolled SAM children aged 6-59 months hospitalised in Borno State, Nigeria. Candidate items associated with inpatient mortality were combined and evaluated as candidate scores. Clinical and statistical methods were used to identify a preferred score. RESULTS: The 513 children enrolled had a mean age of 15.6 months of whom 48 (9%) died. Seven of the 10 evaluated items were significantly associated with mortality. Five different candidate scores were tested. The final score, Responses to Illness Severity Quantification (RISQ), included seven items: heart rate, respiratory rate, respiratory effort, oxygen saturation, oxygen delivery, temperature and level of consciousness. The mean RISQ score on admission was 2.6 in hospital survivors and 7.3 for children dying <48 h. RISQ scores <24 h before death had an area under the receiver operating characteristic curve (AUROC) of 0.93. The RISQ score performed similarly across differing clinical conditions with AUROCs 0.77-0.98 for all conditions except oedema. CONCLUSION: The RISQ score can identify high-risk malnourished children at and during hospital admission. Clinical application may help prioritise care and potentially improve survival.


Asunto(s)
Trastornos de la Nutrición del Niño , Desnutrición Aguda Severa , Niño , Trastornos de la Nutrición del Niño/diagnóstico , Humanos , Lactante , Nigeria , Gravedad del Paciente , Estudios Prospectivos , Desnutrición Aguda Severa/diagnóstico , Índice de Severidad de la Enfermedad
8.
Lancet Glob Health ; 10(4): e510-e520, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-35303461

RESUMEN

BACKGROUND: Global access to acute malnutrition treatment is low. Different programmes using different nutritional products manage cases of severe acute malnutrition and moderate acute malnutrition separately. We aimed to assess whether integrating severe acute malnutrition and moderate acute malnutrition treatment into one programme, using a single nutritional product and reducing the dose as the child improves, could achieve similar or higher individual efficacy, increase coverage, and minimise costs compared with the current programmes. METHODS: We conducted an open-label, non-inferiority, randomised controlled trial in the Democratic Republic of the Congo. Acutely malnourished children aged 6-59 months with a mid-upper-arm circumference (MUAC) of less than 125 mm or oedema were randomly assigned (1:1), using specially developed software and random blocks (size was kept confidential), to either the current standard strategy (one programme for severe acute malnutrition using ready-to-use therapeutic food [RUTF] at an increasing dose as weight increased, another for moderate acute malnutrition using a fixed dose of ready-to-use supplementary food [RUSF]) or the OptiMA strategy (a single programme for both severe acute malnutrition and moderate acute malnutrition using RUTF at a decreasing dose as MUAC and weight increased). The primary endpoint was a favourable outcome at 6 months, defined as being alive, not acutely malnourished as per the definition applied at inclusion, and with no further episodes of acute malnutrition throughout the 6-month observation period; the endpoint was analysed in the intention-to-treat (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, or were prescribed RUSF rations for a minimum of 4 weeks [ie, minimum of 28 RUSF sachets], and had a maximum interval of 6 weeks between any two visits in the 6-month follow-up). The non-inferiority analysis (margin 10%) was to be followed by a superiority analysis (margin 0%) if non-inferiority was concluded. This trial is registered at ClinicalTrials.gov, NCT03751475, and is now closed. FINDINGS: Between July 22 and Dec 6, 2019, 912 children were randomly assigned; after 16 were excluded, 896 were analysed (446 in the standard group and 450 in the OptiMA group). In the intention-to-treat analysis, 282 (63%) of 446 children in the standard group and 325 (72%) of 450 children in the OptiMA group had a favourable outcome (difference -9·0%, 95% CI -15·9 to -2·0). In the per protocol analysis, 161 (61%) of 264 children in the standard group and 291 (74%) of 392 children in the OptiMA group had a favourable outcome (-13·2%, -21·6 to -4·9). INTERPRETATION: In this non-inferiority trial treating children with MUAC of less than 125 mm or oedema, decreasing RUTF dose according to MUAC and weight increase proved to be a superior strategy to the standard protocol in the Democratic Republic of the Congo. These results demonstrate the safety and benefits of an approach that could substantially increase access to treatment for millions of children with acute malnutrition in sub-Saharan Africa. FUNDING: Innocent Foundation and European Civil Protection and Humanitarian Aid Operations. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.


Asunto(s)
Trastornos de la Nutrición del Niño , Desnutrición , Desnutrición Aguda Severa , Niño , República Democrática del Congo/epidemiología , Edema/complicaciones , Humanos , Lactante , Desnutrición/prevención & control , Desnutrición Aguda Severa/complicaciones , Desnutrición Aguda Severa/terapia , Resultado del Tratamiento
9.
Trials ; 23(1): 89, 2022 Jan 28.
Artículo en Inglés | MEDLINE | ID: mdl-35090531

RESUMEN

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.


Asunto(s)
Trastornos de la Nutrición del Niño , Desnutrición , Niño , Trastornos de la Nutrición del Niño/diagnóstico , Trastornos de la Nutrición del Niño/terapia , Edema/diagnóstico , Edema/terapia , Humanos , Desnutrición/diagnóstico , Desnutrición/terapia , Niger , Estado Nutricional , Ensayos Clínicos Controlados Aleatorios como Asunto
10.
Matern Child Nutr ; 18(2): e13291, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-34957682

RESUMEN

Access to treatment for acute malnutrition remains a challenge, in part due to the fragmentation of treatment programmes based on case severity. This paper evaluates utilization patterns, outcomes and associated costs for treating acute malnutrition cases among a cohort of children in Burkina Faso. This study is a secondary analysis of a proof-of-concept trial, called Optimizing treatment for acute Malnutrition (OptiMA), conducted in Burkina Faso in 2016. A total of 4958 eligible children whose mid-upper arm circumference (MUAC) was less than 125 mm or with oedema were followed weekly and given ready-to-use therapeutic foods (RUTF). We evaluated the service utilization and outcomes among patients and estimated resource use and variable cost per patient, and examined factors driving variation in resource use. Children with lower initial MUAC level grew faster but required more time to recover than those with higher initial MUAC level. They also had higher rates of death, default and nonresponse. The simplified OptiMA approach for treating acute malnutrition achieved high rates of recovery overall (84%), especially among less severe cases, with modest quantities of RUTF. The average overall variable cost per child admitted was US$38.0 (SD: 20.5) half of which was accounted for by the cost of RUTF. Cost per recovered case was correlated with case severity, ranging from US$35.1 to US$132.8. If simplified integrated programmes using severity-based RUTF dosing can increase access to treatment at earlier, less severe stages of acute malnutrition, they can help avoid more serious and costlier cases.


Asunto(s)
Desnutrición , Desnutrición Aguda Severa , Burkina Faso/epidemiología , Niño , Edema , Alimentos , Humanos , Lactante , Desnutrición/epidemiología , Desnutrición/terapia , Desnutrición Aguda Severa/epidemiología , Desnutrición Aguda Severa/terapia
11.
Emerg Infect Dis ; 27(12): 3092-3102, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34808083

RESUMEN

We conducted a survey for group-specific indirect immunofluorescence antibody to mammarenaviruses by using Lassa fever and Mopeia virus antigens on serum specimens of 5,363 rodents of 33 species collected in South Africa and Zimbabwe during 1964-1994. Rodents were collected for unrelated purposes or for this study and stored at -70°C. We found antibody to be widely distributed in the 2 countries; antibody was detected in serum specimens of 1.2%-31.8% of 14 species of myomorph rodents, whereas 19 mammarenavirus isolates were obtained from serum specimens and viscera of 4 seropositive species. Phylogenetic analysis on the basis of partial nucleoprotein sequences indicates that 14 isolates from Mastomys natalensis, the Natal multimammate mouse, were Mopeia virus, whereas Merino Walk virus was characterized as a novel virus in a separate study. The remaining 4 isolates from 3 rodent species potentially constitute novel viruses pending full characterization.


Asunto(s)
Arenaviridae , Enfermedades de los Roedores , Animales , Reservorios de Enfermedades , Virus Lassa , Murinae , Filogenia , Sudáfrica/epidemiología , Zimbabwe/epidemiología
12.
J Nutr Sci ; 10: e27, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33996040

RESUMEN

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.


Asunto(s)
Desnutrición , Desnutrición Aguda Severa , Burkina Faso/epidemiología , Preescolar , Humanos , Incidencia , Lactante , Estudios Prospectivos , Recurrencia , Desnutrición Aguda Severa/diagnóstico , Desnutrición Aguda Severa/epidemiología , Desnutrición Aguda Severa/terapia
13.
PLoS Negl Trop Dis ; 15(3): e0009057, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33705395

RESUMEN

Cryptosporidium is a widely distributed enteric parasite that has an increasingly appreciated pathogenic role, particularly in pediatric diarrhea. While cryptosporidiosis has likely affected humanity for millennia, its recent "emergence" is largely the result of discoveries made through major epidemiologic studies in the past decade. There is no vaccine, and the only approved medicine, nitazoxanide, has been shown to have efficacy limitations in several patient groups known to be at elevated risk of disease. In order to help frontline health workers, policymakers, and other stakeholders translate our current understanding of cryptosporidiosis into actionable guidance to address the disease, we sought to assess salient issues relating to clinical management of cryptosporidiosis drawing from a review of the literature and our own field-based practice. This exercise is meant to help inform health system strategies for improving access to current treatments, to highlight recent achievements and outstanding knowledge and clinical practice gaps, and to help guide research activities for new anti-Cryptosporidium therapies.


Asunto(s)
Antiparasitarios/uso terapéutico , Criptosporidiosis/tratamiento farmacológico , Criptosporidiosis/epidemiología , Cryptosporidium/efectos de los fármacos , Nitrocompuestos/uso terapéutico , Tiazoles/uso terapéutico , Preescolar , Cryptosporidium/inmunología , Diarrea/parasitología , Brotes de Enfermedades , Fluidoterapia , Humanos , Huésped Inmunocomprometido/inmunología , Lactante , Recién Nacido
15.
BMJ Open ; 10(12): e041213, 2020 12 02.
Artículo en Inglés | MEDLINE | ID: mdl-33268424

RESUMEN

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.


Asunto(s)
Trastornos de la Nutrición del Niño , Desnutrición , Trastornos de la Nutrición del Niño/diagnóstico , Trastornos de la Nutrición del Niño/terapia , Preescolar , República Democrática del Congo , Humanos , Lactante , Ensayos Clínicos Controlados Aleatorios como Asunto
17.
Sci Rep ; 10(1): 13266, 2020 08 06.
Artículo en Inglés | MEDLINE | ID: mdl-32764545

RESUMEN

Children with moderate acute malnutrition (MAM) are treated based on low weight-for-length z-score (WLZ), low mid-upper arm circumference (MUAC) or both. This study aimed to assess associations of admission criteria and body composition (BC), to improve treatment of MAM. We undertook a cross-sectional study among 6-23 months old Burkinabe children with MAM. Fat-free (FFM) and fat mass (FM) were determined by deuterium dilution and expressed as FFM (FFMI) and FM index (FMI). Of 1,489 children, 439 (29.5%) were recruited by low MUAC only (MUAC-O), 734 (49.3%) by low WLZ and low MUAC (WLZ-MUAC) and 316 (21.2%) by low WLZ only (WLZ-O). Thus, 1,173 (78.8%) were recruited by low MUAC, with or without low WLZ (ALL-MUAC). After adjustments, WLZ-O had 89 g (95% confidence interval (CI) 5; 172) lower FFM compared to MUAC-O. Similarly, WLZ-O had 0.89 kg/m2 (95% CI 0.77; 1.01) lower FFMI compared to MUAC-O, whereas there was no difference for FMI. However, boys included by WLZ-O compared to MUAC-O had 0.21 kg/m2 (95% CI 0.05; 0.38) higher FMI. In contrast, girls included by WLZ-O had 0.17 (95% CI 0.01; 0.33) kg/m2 lower FMI compared to MUAC-O (interaction, p = 0.002). We found that different criteria for admission into MAM treatment programmes select children with differences in BC, especially FFMI.Trial registration: ISRCTN42569496.


Asunto(s)
Tejido Adiposo/metabolismo , Terapia Nutricional/métodos , Desnutrición Aguda Severa/terapia , Antropometría , Composición Corporal , Burkina Faso/epidemiología , Estudios Transversales , Femenino , Humanos , Lactante , Fenómenos Fisiológicos Nutricionales del Lactante , Masculino , Desnutrición Aguda Severa/metabolismo , Resultado del Tratamiento
19.
Br J Nutr ; 123(7): 756-767, 2020 04 14.
Artículo en Inglés | MEDLINE | ID: mdl-31818335

RESUMEN

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.


Asunto(s)
Trastornos de la Nutrición del Niño/epidemiología , Trastornos de la Nutrición del Niño/terapia , Trastornos del Crecimiento/terapia , Burkina Faso/epidemiología , Preescolar , Suplementos Dietéticos , Femenino , Alimentos , Humanos , Lactante , Masculino , Análisis Multivariante , Desnutrición Proteico-Calórica
20.
Ann Work Expo Health ; 63(1): 34-44, 2019 01 07.
Artículo en Inglés | MEDLINE | ID: mdl-30379992

RESUMEN

Objectives: Exposures to respirable crystalline silica (RCS) and respirable dust (RD) were investigated during demolition, crushing, and chipping at several Massachusetts construction sites. Methods: Personal breathing zone samples (n = 51) were collected on operating engineers working at demolition and crushing sites, laborers performing miscellaneous tasks at demolition sites, crushing machine tenders at crushing sites, and chipping workers at substructure bridge repair sites. Area samples (n = 33) were collected at the perimeter of demolition and crushing sites to assess potential bystanders' exposures. Exposures 'with' and 'without' the use of dust suppression methods were compared when possible. RD samples were analyzed for crystalline silica content with Fourier Transform Infrared Spectrophotometry (FT-IR) according to the National Institute for Occupational Safety and Health (NIOSH) Method 7602. Statistical analyses of the exposure data were performed in SAS version 9.4. Results: Chipping workers had the highest exposure levels [the geometric mean (GM) time-weighted average (TWA) for RCS was 527 µg/m3 and the GM for RD was 4750 µg/m3]. The next highest exposures were among crushing machine tenders (RCS GM of 93.3 µg/m3 and RD GM of 737.6 µg/m3), while laborers and operating engineers had the lowest exposures (RCS GM of 17.0 and 6.2 µg/m3, respectively). Personal 8-h TWA RCS exposures were higher than the new OSHA permissible exposure limit (PEL) of 50 µg/m3 for 80% of samples collected on chipping workers (n = 31) and 50% of samples collected on crushing machine tenders (n = 8). Operating engineers (n = 9) and laborers (n = 3) had RCS exposures lower than OSHA PEL. The highest concentrations measured would have exceeded the PEL within 15 min chipping and within 2 h of crushing with no further exposure. Chipping workers' RCS exposures were higher than OSHA PEL even when they were adjusted to account for the assigned protection factor of the half-face N95 cartridge respirators used during chipping. Exposures of crushing tenders were reduced to levels under the OSHA PEL when a water spraying system in crushing machines was utilized, but not when a water cannon machine was used. Area samples at demolition and crushing sites indicate overall lower exposures than the PEL, however, bystander workers at crushing sites could be exposed to higher levels compared to demolition sites. Real-time dust monitoring during demolition indicate very high short-term peak exposures. Conclusions: Controlling or reducing crystalline silica exposures to levels under the new OSHA PEL of 50 µg/m3 remains challenging for chipping workers and crushing machine tenders. Even with the use of dust suppression controls, respiratory protection may be required for various tasks.


Asunto(s)
Contaminantes Ocupacionales del Aire/análisis , Polvo/análisis , Exposición por Inhalación/análisis , Exposición Profesional/análisis , Dióxido de Silicio/análisis , Monitoreo del Ambiente/métodos , Humanos , Espectroscopía Infrarroja por Transformada de Fourier , Lugar de Trabajo/normas
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