Grading of Recommendations, Assessment, Development, and Evaluation (GRADE): Lyophilized CVD 103-HgR Vaccine Among Children and Adolescents Aged 2­17 Years

A Grading of Recommendations, Assessment, Development and Evaluation (GRADE) review of the evidence for benefits and harms for use of lyophilized CVD 103-HgR vaccine (CVD 103-HgR) among children and adolescents aged 2­17 years was presented to the Advisory Committee for Immunization Practices (ACIP) on January 12, 2022. GRADE evidence type indicates the certainty of estimates from the available body of evidence, ranging from type 1 (high certainty) to type 4 (very low certainty).1 The policy question was "Should ACIP recommend lyophilized CVD 103-HgR vaccine for children and adolescents aged 2­17 years traveling to an area with active cholera transmission?" (Table 1). The potential benefits pre-specified by the ACIP Cholera Vaccine Work Group were moderate to severe cholera diarrhea (critical) and cholera diarrhea of any severity (critical). The two pre-specified harms were serious adverse events (SAEs) (critical) and non-serious adverse events (important) (Tables 1 and 2). The work group conducted a systematic review of evidence on the benefits and harms of CVD 103-HgR among children and adolescents aged 2­17 years old. Studies identified were assessed using a modified GRADE approach.1 Regarding benefits, no studies of CVD 103-HgR in children and adolescents aged 2­17 years directly assessed vaccine efficacy or effectiveness against cholera diarrhea. The available data from randomized control trials (RCTs) demonstrated that, compared with placebo, vaccination was associated with a higher risk of serum vibriocidal antibody (SVA) seroconversion (pooled relative risk [RR]: 65.99, 95% CI: 9.43­461.69; pooled absolute risk [AR]: 97,000 more per 100,000, 95% CI: 12,582 more to 100,000 more). The evidence certainty was downgraded for serious imprecision, and the final level of certainty was type 2 (moderate) for both benefits. Regarding harms, the available data from RCTs demonstrated the vaccine and placebo arms had a similar risk of serious adverse events (pooled RR: 0.16, 95% CI 0.01­2.53; pooled AR: 1,120 fewer per 100,000, 95% CI: 1,320 fewer to 2,040 more); no serious adverse events were judged to be related to the vaccine among 468 recipients aged 2­17 years within 6 months of vaccination. The risk of non-serious adverse events was similar between the vaccine and placebo groups (pooled RR: 1.09, 95% CI 0.86­1.38; pooled AR: 4,560 more per 100,000, 95% CI: 7,093 fewer to 19,253 more). For both harms, the evidence certainty was downgraded for very serious imprecision, and the final certainty was type 3 (low).

Efficacy of a Multi-Strain Probiotic Formulation in Pediatric Populations: A Comprehensive Review of Clinical Studies.

A probiotic formulation combining Lactobacillus helveticus Rosell®-52, Bifidobacterium infantis Rosell®-33, and Bifidobacterium bifidum Rosell®-71 with fructooligosaccharides, first commercialized in China, has been sold in over 28 countries since 2002. Clinical studies with this blend of strains were conducted mainly in pediatric populations, and most were published in non-English journals. This comprehensive review summarizes the clinical studies in infants and children to evaluate the efficacy of this probiotic for pediatric indications. Literature searches for pediatric studies on Biostime® or Probiokid® (non-commercial name) in 6 international and Chinese databases identified 28 studies, which were classified by indications. Twelve studies show that the probiotic significantly increases the efficacy of standard diarrhea treatment regardless of etiology, reducing the risk of unresolved diarrhea (RR 0.31 [0.23; 0.42]; p < 0.0001) by 69%. In eight studies, the probiotic enhanced immune defenses, assessed by levels of various immune competence and mucosal immunity markers (six studies), and reduced the incidence of common infections (two studies). The probiotic improved iron deficiency anemia treatment efficacy (three studies), reducing the risk of unresolved anemia by 49% (RR 0.51 [0.28; 0.92]; p = 0.0263) and significantly reducing treatment side effects by 47% (RR 0.53 [0.37; 0.77]; p = 0.0009). Other studies support further investigation into this probiotic for oral candidiasis, eczema, feeding intolerance in premature babies, or hyperbilirubinemia in newborns.

Probióticos y prebióticos: rol en la terapéutica de la enfermedad diarreica aguda infantil / Probiotics and prebiotics: its role in childhood acute diarrheal disease therapy

RESUMEN: La enfermedad diarreica aguda infantil (EDAI), constituye un problema de salud pública, representando la 2ª causa de morbimortalidad infantil en menores de 5 años, en el Ecuador. La hidratación oral y parenteral en los niños hospitalizados bajo normas de administración de conformidad con el grado de deshidratación y pérdida de peso, así como medidas preventivas como la vacunación obligatoria contra el rotavirus, han contribuido a disminuir, pero no a solucionar este problema de salud infantil. Múltiples factores contribuyen para que no se resuelva: socioeconómicos, educacionales, el destete temprano y malas prácticas alimenticias, entre otros. Últimos estudios han propuesto la utilización de probióticos que contribuyan a disminuir el problema sugieriendo el usode Saccharomyces boulardii (SB), asociado a un prebiótico; lo que permitiría acortar el tiempo de tratamiento de una EDAI; por lo que la simbiosis entre SB y un prebiótico denominado fructooligosacárido (FOS), podría ser una alternativa para reducir costos y complicaciones. Una alternativa para medir el curso clínico de una EDAI en infantes es la escala BITTS, de reciente creación y fácil aplicación por clínicos. El objetivo de este manuscrito fue resumir la evidencia existente respecto del rol de losprobióticos y prebióticos en la terapéutica de de la EDAI.

SUMMARY: In Ecuador childhood acute diarrheal disease (CADD) constitutes a serious public health problem, representing the 2nd cause of infant morbidity and mortality in children under 5 years of age. Oral and parenteral hydration in hospitalized children, with standard treatments according to their degree of dehydration and weight loss, as well as preventive measures such as mandatory vaccination against rotavirus, have contributed to a decrease. Nevertheless, this childhood disease has still not been resolved. There are multiple contributing factors involved that prevent complete eradication of the disease Among these are socio-economic problems, education, early weaning and poor feeding practices, all of which continue to affect infants. Recent studies have proposed the use of probiotics that help reduce the problem and it has been suggested that Saccharomyces boulardii (SB), associated with a prebiotic, would reduce the treatment time of an CADD. Therefore, the symbiosis between the SB probiotic and a prebiotic called fructo- oligosaccharide (FOS) could be an alternative to reduce complications and reduce costs. An alternative to measure the clinical course of an CADD in infants is the BITTS scale, which was recently created and can easily be applied by clinicians. The aim of this manuscript was to summarize the existing evidence regarding the role of PROBIOTICS and prebiotics in the treatment of CADD.

Tecnologias para a autoeficácia materna na prevenção da diarreia infantil: ensaio clínico / Tecnologías para la autoeficacia materna en la prevención de la diarrea infantil: ensayo clínico / Technologies for maternal self-efficacy in preventing childhood diarrhea: a clinical trial

Resumo Objetivo: Avaliar os efeitos de duas tecnologias educativas, vídeo e cartilha, associadas à entrevista motivacional para promover a autoeficácia materna na prevenção da diarreia infantil. Métodos: Ensaio clínico com 122 mães de crianças menores de 5 anos, randomizadas aleatoriamente em dois grupos: vídeo educativo ("Diarreia Infantil: você é capaz de prevenir") aliado à Entrevista Motivacional Breve ou cartilha ("Você é capaz de prevenir a diarreia no seu filho!") aliada à Entrevista Motivacional Breve. A coleta ocorreu presencialmente no primeiro contato com as mães, na unidade de atenção primária à saúde, aplicando-se a Escala de Autoeficácia Materna para prevenção da Diarreia Infantil e um formulário sociodemográfico. O segundo e terceiro momentos de coleta de dados ocorreram por telefone, após um e dois meses, respectivamente, utilizando-se a escala e um formulário de investigação da diarreia. Resultados: Constatou-se que um mês após as intervenções, a maioria das participantes dos dois grupos foram consideradas com autoeficácia elevada para prevenção da diarreia infantil, sendo 78,4% das mães no grupo vídeo e entrevista motivacional e; 83,0% no grupo cartilha e entrevista motivacional. Dois meses após as intervenções, as médias dos escores de autoeficácia materna elevaram-se e tiveram redução nos casos de diarreia infantil, em ambos os grupos. Conclusão: Comprovou-se que essas tecnologias educativas aliadas à entrevista motivacional breve elevaram a autoeficácia para prevenir a diarreia infantil. Logo, podem ser utilizadas pelos enfermeiros que atuam na Atenção Primária à Saúde, como uma ferramenta educativa.

Resumen Objetivo: Evaluar los efectos de dos tecnologías educativas, video y cartilla, junto con la encuesta motivacional, para promover la autoeficacia materna en la prevención de la diarrea infantil. Métodos: Ensayo clínico con 122 madres de niños menores de 5 años, aleatorizadas en dos grupos: video educativo ("Diarrea infantil: tú puedes prevenirla") junto con la encuesta motivacional breve o cartilla ("¡Tú puedes prevenir la diarrea de tu hijo!") junto con la encuesta motivacional breve. La recolección se realizó presencialmente en el primer contacto con las madres, en la unidad de atención primaria de salud, mediante la implementación de la Escala de Autoeficacia Materna para la Prevención de la Diarrea Infantil y un formulario sociodemográfico. El segundo y tercer momento de recolección de datos fue por teléfono, luego de uno y dos meses, respectivamente, mediante la escala y un formulario de investigación de la diarrea. Resultados: Se constató que, un mes después de las intervenciones, la mayoría de las participantes de los dos grupos fueron consideradas con autoeficacia elevada para la prevención de la diarrea infantil, de las cuales el 78,4 % pertenecían al grupo video y encuesta motivacional y el 83,0 % al grupo cartilla y encuesta motivacional. Dos meses después de las intervenciones, el promedio de la puntuación de autoeficacia materna aumentó y se redujeron los casos de diarrea infantil en ambos grupos. Conclusión: Se comprobó que estas tecnologías educativas, junto con la encuesta motivacional breve, aumentaron la autoeficacia para prevenir la diarrea infantil. Por lo tanto, pueden ser utilizadas por los enfermeros que actúan en la atención primaria de salud, como herramienta educativa.

Abstract Objective: To assess the effects of two educational technologies, video and booklet, associated with Motivational Interviewing to promote maternal self-efficacy in preventing childhood diarrhea. Methods: A clinical trial conducted with 122 mothers of children under 5 years old; mothers were randomly randomized into two groups: educational video ("Child's diarrhea: you are able to prevent it") combined with Brief Motivational Interviewing or booklet ("You are able to prevent diarrhea in your child!") combined with Brief Motivational Interviewing. Data collection took place in the first contact with the mothers at the Primary Health Care unit; the Maternal Self-Efficacy Scale for preventing childhood diarrhea and a sociodemographic form were applied. The second and third moments of data collection occurred through telephone, after one and two months, respectively, using the scale and a form for investigating diarrhea. Results: It was found that one month after the interventions, most of the participants in both groups were considered to have high self-efficacy in preventing childhood diarrhea, with 78.4% of mothers in the video and Motivational Interviewing group; 83.0% in the booklet and Motivational Interviewing group. Two months after the interventions, mean maternal self-efficacy scores increased and decreased in cases of childhood diarrhea in both groups. Conclusion: It has been proved that these educational technologies, combined with Brief Motivational Interviewing, increased self-efficacy to prevent childhood diarrhea. Therefore, they can be used by nurses working at Primary Health Care as an educational tool.

Determinantes sociais de saúde e autoeficácia de mães/cuidadores para prevenção da diarreia / Determinantes sociales de salud y autoeficacia de madres/cuidadores para prevención de diarrea / Social determinants of health and self-efficacy of mothers/caregivers for preventing diarrhea

Resumo Objetivo Verificar associação entre os determinantes sociais de saúde e os níveis de autoeficácia de mães ou cuidadores para prevenção da diarreia infantil. Métodos Estudo transversal realizado com 363 mães ou cuidadores de crianças menores de cinco anos, acompanhadas em unidade de Atenção Primária à Saúde. Para coleta de dados, utilizaram-se o formulário de caracterização sociodemográfica e a Escala de Autoeficácia Materna para Prevenção da Diarreia Infantil. Realizou-se o teste Qui-Quadrado e como medida de associação a razão de chances. Resultados Verificou-se que mães ou cuidadores com idades de 15 a 29 anos tiveram 1,6 vezes mais chances de apresentarem autoeficácia moderada, com significância estatística para o determinante individual "faixa etária" (p=0,017). Os participantes com determinantes intermediários "destino do lixo" e "origem da água do domicílio" inadequados tiveram, respectivamente, 3,5 e 2,8 vezes mais chances de apresentarem autoeficácia moderada. Conclusão O Determinante Social de Saúde "faixa etária" aumenta a chance de mães ou cuidadores apresentarem autoeficácia moderada para prevenção da diarreia infantil. Portanto, cabe aos enfermeiros uma maior ênfase em orientar as mães ou cuidadores, principalmente os mais jovens sobre a prevenção da diarreia e realizar ações educativas que visem aumentar a autoeficácia destes.

Resumen Objetivo Verificar la relación entre los determinantes sociales de salud y los niveles de autoeficacia de madres o cuidadores para la prevención de diarrea infantil. Métodos Estudio transversal realizado con 363 madres o cuidadores de niños menores de cinco años, atendidas en una unidad de Atención Primaria de Salud. Para la recopilación de datos se utilizó el formulario de caracterización sociodemográfica y la Escala de Autoeficacia Materna para la Prevención de la Diarrea Infantil. Se realizó la prueba χ2 de Pearson y, como medida de asociación, la razón de momios. Resultados Se verificó que las madres o cuidadores con edad de 15 a 29 años tuvieron 1,6 veces más chances de presentar autoeficacia moderada, con significación estadística del determinante individual "grupo de edad" (p=0,017). Los participantes con determinantes intermedios "destino de la basura" y "origen del agua del domicilio" inadecuados tuvieron más probabilidades de presentar autoeficacia moderada, 3,5 y 2,8 respectivamente. Conclusión El determinante social de salud "grupo de edad" aumenta la probabilidad de que madres o cuidadores presenten autoeficacia moderada para la prevención de la diarrea infantil. Por lo tanto, corresponde a los enfermeros hacer hincapié en orientar a las madres o cuidadores, principalmente los más jóvenes, sobre la prevención de la diarrea y realizar acciones educativas con el objetivo de aumentar su autoeficacia.

Abstract Objective To verify the association between the social determinants of health and the levels of self-efficacy of mothers or caregivers to prevent childhood diarrhea. Methods This is a cross-sectional study carried out with 363 mothers or caregivers of children under five years old, followed up in a Primary Health Care unit. For data collection, the sociodemographic characterization form and the Maternal Self-Efficacy Questionnaire for Prevention of Infantile diarrhea. The Chi-Square test was performed, and as a measure of association, odds ratio. Results It was found that mothers or caregivers aged 15 to 29 years were 1.6 times more likely to have moderate self-efficacy, with statistical significance for the individual determinant "age group" (p=0.017). Participants with inadequate intermediate determinants "waste destination" and "home water source" were 3.5 and 2.8 times more likely to have moderate self-efficacy, respectively. Conclusion The social determinant of health "age group" increases the chance of mothers or caregivers showing moderate self-efficacy to prevent childhood diarrhea. Therefore, nurses should place a greater emphasis on guiding mothers or caregivers, especially younger ones, on the prevention of diarrhea and carrying out educational actions aimed at increasing their self-efficacy.

Household flooring associated with reduced infant diarrhoeal illness in Zimbabwe in households with and without WASH interventions.

OBJECTIVES: Diarrhoeal illness is a leading cause of childhood morbidity and mortality and has long-term negative impacts on child development. Although flooring, water and sanitation have been identified as important routes of transmission of diarrhoeal pathogens, research examining variability in the association between flooring and diarrhoeal illness by water and sanitation is limited. METHODS: We utilised cross-sectional data collected for the evaluation of Zimbabwe's Prevention of Mother-to-Child HIV transmission programme in 2014 and 2017-18. Mothers of infants 9-18 months of age self-reported the household's source of drinking water and type of sanitation facility, as well as infant diarrhoeal illness in the four weeks prior to the survey. Household flooring was assessed using interviewer observation, and households in which the main material of flooring was dirt/earthen were classified as having unimproved flooring, and those with solid flooring (e.g. cement) were classified as having improved flooring. RESULTS: Mothers of infants living in households with improved flooring were less likely to report diarrhoeal illness in the last four weeks (PDa  = -4.8%, 95% CI: -8.6, -1.0). The association between flooring and diarrhoeal illness did not vary by the presence of improved/unimproved water (pRERI  = 0.91) or sanitation (pRERI  = 0.76). CONCLUSIONS: Our findings support the hypothesis that household flooring is an important pathway for the transmission of diarrhoeal pathogens, even in settings where other aspects of sanitation are sub-optimal. Improvements to household flooring do not require behaviour change and may be an effective and expeditious strategy for reducing childhood diarrhoeal illness irrespective of household access to improved water and sanitation.

OBJECTIFS: Les maladies diarrhéiques sont l'une des principales causes de morbidité et de mortalité infantiles et ont des effets négatifs à long terme sur le développement de l'enfant. Bien que le revêtement de sol, l'eau et l'assainissement aient été identifiés comme des voies de transmission importantes des agents pathogènes diarrhéiques, la recherche examinant la variabilité de l'association entre le revêtement de sol et les maladies diarrhéiques par l'eau et les sanitaires est rare. MÉTHODES: Nous avons utilisé des données transversales collectées pour l'évaluation du programme de prévention de la transmission du VIH de la mère à l'enfant au Zimbabwe en 2014 et 2017-18. Les mères de nourrissons âgés de 9 à 18 mois ont déclaré la source d'eau potable du ménage et le type d'installation sanitaire, ainsi que les maladies diarrhéiques de l'enfant au cours des quatre semaines précédant l'enquête. Le revêtement de sol des ménages a été évalué en utilisant l'observation de l'intervieweur. Les ménages dont le principal matériau de revêtement de sol était de la terre étaient classés comme ayant un revêtement de sol non amélioré et les ménages dont le revêtement de sol était en ciment étaient classés comme ayant un revêtement de sol amélioré. RÉSULTATS: Les mères de nourrissons vivant dans des ménages avec un revêtement de sol amélioré étaient moins susceptibles de déclarer une maladie diarrhéique au cours des quatre semaines précédentes (PDa = --9%, IC95%: -8,6 à -1,0). L'association entre les revêtements de sol et les maladies diarrhéiques ne variait pas selon la présence d'eau améliorée/non améliorée (p RERI = 0,91) ou de sanitaires (p RERI = 0,76). CONCLUSIONS: Nos résultats corroborent l'hypothèse selon laquelle le revêtement de sol domestique est une voie importante pour la transmission d'agents pathogènes diarrhéiques, même dans des contextes où d'autres aspects des sanitaires ne sont pas optimaux. L'amélioration du revêtement de sol domestique ne nécessite pas de changement de comportement et peut être une stratégie efficace et rapide pour réduire les maladies diarrhéiques infantiles, indépendamment de l'accès des ménages à une eau et à des sanitaires améliorés.

Epidemiological characteristics and strategies for the prevention of diarrheal disease in indigenous children: A scoping review / Características epidemiológicas y estrategias para la prevención de la diarrea en niños indígenas: una revisión scoping

Aim: The a:im of the present scoping review was to map the scientific evidence about iarrheal disease in indigenous children and the strategies that can be used to prevent it. Methods: The subject headings were indigenous population; child; diarrhea; dysentery; epidemiology; and prevention, primary; also the following keywords characteristic, epidemiologic study; and children. The databases consulted were Latin American and Caribbean Health Sciences Literature, MEDLINE via the US National Library of Medicine/National Institutes of Health, and Web of Science. Initially, 268 studies were identified, and after being screened using the eligibility criteria, six were selected. Finally, via reference tracking, five more were identified. The final sample was made up of eleven articles. Results: The results confirmed higher mortality rates due to diarrheal disease among indigenous children who are socially disadvantaged and living in poor hygienic and basic sanitation conditions. Among the primary prevention strategies are basic sanitation, health education better hygiene habits, animal control, breastfeeding, supplementing the diet with zinc, vitamins, and the rotavirus vaccine. The preventive strategies included the use of oral rehydration solutions, adequate nutrition, prescribed antimicrobials, and intravenous fluid replacement with glycaemic and electrolyte correction in severe cases. Conclusion: In conclusion, public policies regarding the indigenous population and cross-cultural care should be strengthened. The present study confirmed that, at a global level, there is a lack of publications studying this issue

Objetivo: El objetivo de la presente scoping review fue mapear las evidencias científicas sobre la enfermedad diarreica en niños indígenas y las estrategias que se pueden usar para prevenirla. Método: Se utilizó el siguiente vocabulario controlado: población indígena, niño, diarrea, disentería, epidemiología y prevención primaria, también las siguientes palabras clave: estudio epidemiológico característico y niño. Las bases de datos consultadas fueron Literatura Latinoamericana y del Caribe en Ciencias de la Salud (LILACS), MEDLINE a través de la Biblioteca Nacional de Medicina de EE. UU./Institutos Nacionales de Salud (PubMed) y Web of Science. Inicialmente, 268 estudios fueron identificados y, después de ser seleccionados usando los criterios de elegibilidad, 6 fueron seleccionados. Finalmente, a través del rastreo de referencia, 5 más fueron identificados. La muestra final se compuso de 11 artículos. Resultados: Los resultados confirmaron tasas de mortalidad más altas debido a la enfermedad diarreica entre niños indígenas socialmente desfavorecidos, y que viven en malas condiciones higiénicas y de saneamiento básico. Entre las principales estrategias de prevención están saneamiento básico, educación en salud, mejores hábitos de higiene, control de animales, lactancia, suplementación de la dieta con cinc, vitaminas y vacuna contra el rotavirus. Estrategias de prevención incluyen el uso de soluciones de rehidratación oral, nutrición adecuada, antimicrobianos prescritos y reposición intravenosa de líquidos con corrección glucémica y electrolítica en casos graves. Conclusión: Las políticas públicas en relación a la población indígena y el cuidado transcultural deben ser fortalecidas. El presente estudio confirmó que, a nivel global, faltan publicaciones estudiando esta cuestión

El Niño-Southern oscillation and under-5 diarrhea in Botswana.

Childhood diarrheal disease causes significant morbidity and mortality in low and middle-income countries, yet our ability to accurately predict diarrhea incidence remains limited. El Niño-Southern Oscillation (ENSO) has been shown to affect diarrhea dynamics in South America and Asia. However, understanding of its effects in sub-Saharan Africa, where the burden of under-5 diarrhea is high, remains inadequate. Here we investigate the connections between ENSO, local environmental conditions, and childhood diarrheal disease in Chobe District, Botswana. Our results demonstrate that La Niña conditions are associated with cooler temperatures, increased rainfall, and higher flooding in the Chobe region during the rainy season. In turn, La Niña conditions lagged 0-5 months are associated with higher than average incidence of under-5 diarrhea in the early rainy season. These findings demonstrate the potential use of ENSO as a long-lead prediction tool for childhood diarrhea in southern Africa.

Day care attendance during the first 12 months of life and occurrence of infectious morbidities and symptoms / Frequência em creches durante os primeiros 12 meses de vida e ocorrência de morbidades e sintomas infecciosos

ABSTRACT Objective: To investigate the occurrence of infectious morbidities according to day care attendance during the first year of life. Methods: This was a cross-sectional analysis of data from the 12-month follow-up of a medium-sized city birth cohort from children born in 2015, in the Southern Brazil. Main exposure variables were day care attendance from 0 to 11 months of age, type of day care center (public or private), and age at entering day care. Health outcomes were classified as follows: "non-specific respiratory symptoms," "upper respiratory tract infection," "lower respiratory tract infection," "flu/cold," "diarrhea," or "no health problem," considering the two weeks prior to the interview administered at 12 months of life. Associations were assessed using Poisson regression adjusted by demographic, behavioral, and socioeconomic variables. Results: The sample included 4018 children. Day care attendance was associated with all classifications of health outcomes mentioned above, except for flu/cold. These were stronger among children who entered day care at an age closer to the outcome time-point. An example are the results for lower respiratory tract infection and diarrhea, with adjusted prevalence ratios of 2.79 (95% CI: 1.67-4.64) and 2.04 (95% CI: 1.48-2.82), respectively, for those who entered day care after 8 months of age when compared with those who never attended day care. Conclusions: The present study consistently demonstrated the association between day care attendance and higher occurrence of infectious morbidities and symptoms at 12 months of life. Hence, measures to prevent infectious diseases should give special attention to children attending day care centers.

RESUMO Objetivo: Investigar a ocorrência de morbidades infecciosas de acordo com a frequência em creches durante o primeiro ano de vida. Métodos: Esta foi uma análise transversal dos dados de uma coorte de nascimento, em uma cidade de tamanho médio, na visita aos 12 meses de idade de crianças nascidas em 2015 no Sul do Brasil. As principais variáveis de exposição foram frequência em creches de zero aos 11 meses de idade, tipo de creche (pública ou particular) e idade ao entrar na creche. Os resultados de saúde foram classificados como: "sintomas respiratórios não específicos", "infecção do trato respiratório superior", "infecção do trato respiratório inferior", "gripe/resfriado", "diarreia" ou "nenhum problema de saúde", considerando as duas semanas anteriores à entrevista feita aos 12 meses de vida da criança. As associações foram avaliadas com a regressão de Poisson ajustada pelas variáveis demográficas, comportamentais e socioeconômicas. Resultados: A amostra incluiu 4.018 crianças. O ato de frequentar creches foi associado a todas as classificações de resultados de saúde mencionados, exceto gripe/resfriado. Esses resultados foram mais fortes entre as crianças que começaram a frequentar creches em uma idade mais próxima ao ponto de tempo do resultado. Um exemplo são os resultados para infecção do trato respiratório inferior e diarreia, índice de prevalência ajustado de 2,79 (IC de 95%: 1,67-4,64) e 2,04 (IC de 95%: 1,48-2,82), respectivamente, naqueles que ingressaram nas creches após os oito meses de idade, em comparação com aqueles que nunca frequentaram creche. Conclusões: O presente estudo mostra sistematicamente a associação entre a frequência em creches e a maior ocorrência de morbidades infecciosas e sintomas aos 12 meses de vida da criança. Assim, deve-se dar atenção especial às medidas para prevenir as doenças infecciosas em crianças que frequentes creches.

Vaccines for preventing rotavirus diarrhoea: vaccines in use.

BACKGROUND: Rotavirus results in more diarrhoea-related deaths in children under five years than any other single agent in countries with high childhood mortality. It is also a common cause of diarrhoea-related hospital admissions in countries with low childhood mortality. Rotavirus vaccines that have been prequalified by the World Health Organization (WHO) include a monovalent vaccine (RV1; Rotarix, GlaxoSmithKline), a pentavalent vaccine (RV5; RotaTeq, Merck), and, more recently, another monovalent vaccine (Rotavac, Bharat Biotech). OBJECTIVES: To evaluate rotavirus vaccines prequalified by the WHO (RV1, RV5, and Rotavac) for their efficacy and safety in children. SEARCH METHODS: On 4 April 2018 we searched MEDLINE (via PubMed), the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in the Cochrane Library), Embase, LILACS, and BIOSIS. We also searched the WHO ICTRP, ClinicalTrials.gov, clinical trial reports from manufacturers' websites, and reference lists of included studies and relevant systematic reviews. SELECTION CRITERIA: We selected randomized controlled trials (RCTs) in children comparing rotavirus vaccines prequalified for use by the WHO versus placebo or no intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility and assessed risks of bias. One review author extracted data and a second author cross-checked them. We combined dichotomous data using the risk ratio (RR) and 95% confidence interval (CI). We stratified the analysis by country mortality rate and used GRADE to evaluate evidence certainty. MAIN RESULTS: Fifty-five trials met the inclusion criteria and enrolled a total of 216,480 participants. Thirty-six trials (119,114 participants) assessed RV1, 15 trials (88,934 participants) RV5, and four trials (8432 participants) Rotavac. RV1 Children vaccinated and followed up the first year of life In low-mortality countries, RV1 prevents 84% of severe rotavirus diarrhoea cases (RR 0.16, 95% CI 0.09 to 0.26; 43,779 participants, 7 trials; high-certainty evidence), and probably prevents 41% of cases of severe all-cause diarrhoea (RR 0.59, 95% CI 0.47 to 0.74; 28,051 participants, 3 trials; moderate-certainty evidence). In high-mortality countries, RV1 prevents 63% of severe rotavirus diarrhoea cases (RR 0.37, 95% CI 0.23 to 0.60; 6114 participants, 3 trials; high-certainty evidence), and 27% of severe all-cause diarrhoea cases (RR 0.73, 95% CI 0.56 to 0.95; 5639 participants, 2 trials; high-certainty evidence). Children vaccinated and followed up for two years In low-mortality countries, RV1 prevents 82% of severe rotavirus diarrhoea cases (RR 0.18, 95% CI 0.14 to 0.23; 36,002 participants, 9 trials; high-certainty evidence), and probably prevents 37% of severe all-cause diarrhoea episodes (rate ratio 0.63, 95% CI 0.56 to 0.71; 39,091 participants, 2 trials; moderate-certainty evidence). In high-mortality countries RV1 probably prevents 35% of severe rotavirus diarrhoea cases (RR 0.65, 95% CI 0.51 to 0.83; 13,768 participants, 2 trials; high-certainty evidence), and 17% of severe all-cause diarrhoea cases (RR 0.83, 95% CI 0.72 to 0.96; 2764 participants, 1 trial; moderate-certainty evidence). No increased risk of serious adverse events (SAE) was detected (RR 0.88 95% CI 0.83 to 0.93; high-certainty evidence). There were 30 cases of intussusception reported in 53,032 children after RV1 vaccination and 28 cases in 44,214 children after placebo or no intervention (RR 0.70, 95% CI 0.46 to 1.05; low-certainty evidence). RV5 Children vaccinated and followed up the first year of life In low-mortality countries, RV5 probably prevents 92% of severe rotavirus diarrhoea cases (RR 0.08, 95% CI 0.03 to 0.22; 4132 participants, 5 trials; moderate-certainty evidence). We did not identify studies reporting on severe all-cause diarrhoea in low-mortality countries. In high-mortality countries, RV5 prevents 57% of severe rotavirus diarrhoea (RR 0.43, 95% CI 0.29 to 0.62; 5916 participants, 2 trials; high-certainty evidence), but there is probably little or no difference between vaccine and placebo for severe all-cause diarrhoea (RR 0.80, 95% CI 0.58 to 1.11; 1 trial, 4085 participants; moderate-certainty evidence). Children vaccinated and followed up for two years In low-mortality countries, RV5 prevents 82% of severe rotavirus diarrhoea cases (RR 0.18, 95% CI 0.08 to 0.39; 7318 participants, 4 trials; moderate-certainty evidence). We did not identify studies reporting on severe all-cause diarrhoea in low-mortality countries. In high-mortality countries, RV5 prevents 41% of severe rotavirus diarrhoea cases (RR 0.59, 95% CI 0.43 to 0.82; 5885 participants, 2 trials; high-certainty evidence), and 15% of severe all-cause diarrhoea cases (RR 0.85, 95% CI 0.75 to 0.98; 5977 participants, 2 trials; high-certainty evidence). No increased risk of serious adverse events (SAE) was detected (RR 0.93 95% CI 0.86 to 1.01; moderate to high-certainty evidence). There were 16 cases of intussusception in 43,629 children after RV5 vaccination and 20 cases in 41,866 children after placebo (RR 0.77, 95% CI 0.41 to 1.45; low-certainty evidence). Rotavac Children vaccinated and followed up the first year of life Rotavac has not been assessed in any RCT in countries with low child mortality. In India, a high-mortality country, Rotavac probably prevents 57% of severe rotavirus diarrhoea cases (RR 0.43, 95% CI 0.30 to 0.60; 6799 participants, moderate-certainty evidence); the trial did not report on severe all-cause diarrhoea at one-year follow-up. Children vaccinated and followed up for two years Rotavac probably prevents 54% of severe rotavirus diarrhoea cases in India (RR 0.46, 95% CI 0.35 to 0.60; 6541 participants, 1 trial; moderate-certainty evidence), and 16% of severe all-cause diarrhoea cases (RR 0.84, 95% CI 0.71 to 0.98; 6799 participants, 1 trial; moderate-certainty evidence). No increased risk of serious adverse events (SAE) was detected (RR 0.93 95% CI 0.85 to 1.02; moderate-certainty evidence). There were eight cases of intussusception in 5764 children after Rotavac vaccination and three cases in 2818 children after placebo (RR 1.33, 95% CI 0.35 to 5.02; very low-certainty evidence). There was insufficient evidence of an effect on mortality from any rotavirus vaccine (198,381 participants, 44 trials; low- to very low-certainty evidence), as the trials were not powered to detect an effect at this endpoint. AUTHORS' CONCLUSIONS: RV1, RV5, and Rotavac prevent episodes of rotavirus diarrhoea. Whilst the relative effect estimate is smaller in high-mortality than in low-mortality countries, there is a greater number of episodes prevented in these settings as the baseline risk is much higher. We found no increased risk of serious adverse events. 21 October 2019 Up to date All studies incorporated from most recent search All published trials found in the last search (4 Apr, 2018) were included and 15 ongoing studies are currently awaiting completion (see 'Characteristics of ongoing studies').

CONTEXTE: Le rotavirus entraîne plus de décès liés à la diarrhée chez les enfants de moins de cinq ans que tout autre agent unique dans les pays où la mortalité infantile est élevée. C'est également une cause fréquente d'hospitalisations liées à la diarrhée dans les pays où la mortalité infantile est faible. Les vaccins antirotavirus préqualifiés par l'Organisation mondiale de la santé (OMS) comprennent un vaccin monovalent (RV1 ; Rotarix, GlaxoSmithKline), un vaccin pentavalent (RV5 ; RotaTeq, Merck) et plus récemment un autre vaccin monovalent (Rotavac, Bharat Biotech). OBJECTIFS: Évaluer les vaccins antirotavirus préqualifiés par l'OMS (RV1, RV5 et Rotavac) pour leur efficacité et leur innocuité chez les enfants. STRATÉGIE DE RECHERCHE DOCUMENTAIRE: Le 4 avril 2018, nous avons effectué une recherche dans MEDLINE (via PubMed), le registre spécialisé du groupe de travail Cochrane sur les maladies infectieuses (the Cochrane Infectious Diseases Group), CENTRAL (publié dans la Bibliothèque Cochrane), Embase, LILACS, et BIOSIS. Nous avons également effectué des recherches dans le système d'enregistrement international des essais cliniques (ICTRP) de l'OMS, ClinicalTrials.gov, les rapports d'essais cliniques trouvés sur les sites Web des fabricants, les références des études incluses et les revues systématiques pertinentes. CRITÈRES DE SÉLECTION: Nous avons sélectionné des essais cliniques contrôlés randomisés (ECR) chez des enfants comparant des vaccins antirotavirus préqualifiés pour utilisation par l'OMS à un placebo ou à aucune intervention. RECUEIL ET ANALYSE DES DONNÉES: Deux auteurs de la revue ont évalué de façon indépendante l'éligibilité à l'essai et évalué les risques de biais. Un auteur de la revue a extrait les données et un deuxième auteur les a vérifiées par recoupement. Nous avons combiné des données dichotomiques en utilisant le risque relatif (RR) et l'intervalle de confiance à 95 % (IC). Nous avons stratifié l'analyse par taux de mortalité par pays et utilisé GRADE pour évaluer la valeur probante des données. RÉSULTATS PRINCIPAUX: Cinquante­cinq essais ont satisfait aux critères d'inclusion et enrôlé 216 480 participants au total. Trente­six essais cliniques (119 114 participants) ont évalué le RV1, 15 essais cliniques (88 934 participants) le RV5 et quatre essais cliniques (8432 participants) le Rotavac. RV1 Enfants vaccinés et suivis au cours de leur première année de vie Dans les pays à faible mortalité, le RV1 prévient 84 % des cas graves de diarrhée à rotavirus (RR 0,16, IC à 95 % : 0,09 à 0,26 ; 43 779 participants, 7 essais ; données de bonne valeur probante) et probablement 41 % des cas de diarrhée sévère toutes causes confondues (RR 0,59, IC à 95 % : 0,47 à 0,74 ; 28 051 participants, 3 essais ; données de valeur probante moyenne). Dans les pays à forte mortalité, le RV1 prévient 63 % des cas graves de diarrhée à rotavirus (RR 0,37, IC à 95 % : 0,23 à 0,60 ; 6114 participants, 3 essais ; données de bonne valeur probante) et 27 % des cas graves de diarrhée toutes causes confondues (RR 0,73, IC à 95 % : 0,56 à 0,95 ; 5639 participants, 2 essais ; données de bonne valeur probante). Enfants vaccinés et suivis pendant deux ans Dans les pays à faible mortalité, le RV1 prévient 82 % des cas graves de diarrhée à rotavirus (RR 0,18, IC à 95 % : 0,14 à 0,23 ; 36 002 participants, 9 essais ; données de bonne valeur probante) et probablement 37 % des épisodes graves de diarrhée toutes causes confondues (rapport des taux 0,63, IC à 95 % : 0,56 à 0,71 ; 39 091 participants, 2 essais ; données de valeur probante moyenne). Dans les pays à forte mortalité, le RV1 prévient probablement 35 % des cas graves de diarrhée à rotavirus (RR 0,65, IC à 95 % : 0,51 à 0,83 ; 13 768 participants, 2 essais ; données de bonne valeur probante) et 17 % des cas graves de diarrhée toutes causes confondues (RR 0,83, IC à 95 % : 0,72 à 0,96 ; 2764 participants, 1 essai ; données de valeur probante moyenne). Aucune augmentation du risque d'événements indésirables graves (EIG) n'a été décelée (RR 0,88 IC à 95 % 0,83 à 0,93 ; données de bonne valeur probante). On a signalé 30 cas d'invagination (intussusception) intestinale chez 53 032 enfants après la vaccination RV1 et 28 cas chez 44 214 enfants après l'administration d'un placebo ou l'absence d'intervention (RR 0,70, IC à 95 % : 0,46 à 1,05 ; données de faible valeur probante). RV5 Enfants vaccinés et suivis au cours de leur première année de vie Dans les pays à faible mortalité, le RV5 prévient probablement 92 % des cas graves de diarrhée à rotavirus (RR 0,08, IC à 95 % : 0,03 à 0,22 ; 4 132 participants, 5 essais ; données de valeur probante moyenne). Nous n'avons pas identifié d'études sur les diarrhées graves toutes causes confondues dans les pays à faible mortalité. Dans les pays à forte mortalité, le RV5 prévient 57 % des cas de diarrhée à rotavirus grave (RR 0,43, IC à 95 % : 0,29 à 0,62 ; 5916 participants, 2 essais ; données de bonne valeur probante), mais il n'y a probablement que peu voire pas de différence entre vaccin et placebo pour la diarrhée grave toutes causes confondues (RR 0,80, IC à 95 % : 0,58 à 1,11 ; 1 essai, 4085 participants ; données de valeur probante moyenne). Enfants vaccinés et suivis pendant deux ans Dans les pays à faible mortalité, le RV5 prévient 82 % des cas graves de diarrhée à rotavirus (RR 0,18, IC à 95 % : 0,08 à 0,39 ; 7318 participants, 4 essais ; données de valeur probante moyenne). Nous n'avons pas identifié d'études sur les diarrhées graves toutes causes confondues dans les pays à faible mortalité. Dans les pays à forte mortalité, le RV5 prévient 41 % des cas graves de diarrhée à rotavirus (RR 0,59, IC à 95 % : 0,43 à 0,82 ; 5 885 participants, 2 essais ; données de bonne valeur probante) et 15 % des cas graves de diarrhée toutes causes confondues (RR 0,85, IC à 95 % : 0,75 à 0,98 ; 5977 participants, 2 essais ; données de bonne valeur probante). Aucune augmentation du risque d'évènements indésirables graves (EIG) n'a été décelée (RR 0,93 IC à 95 % 0,86 à 1,01 ; données de valeur probante moyenne à bonne). Il y a eu 16 cas d'invagination chez 43 629 enfants après la vaccination RV5 et 20 cas chez 41 866 enfants après le placebo (RR 0,77, IC à 95 % : 0,41 à 1,45 ; données de faible valeur probante). Rotavac Enfants vaccinés et suivis au cours de leur première année de vie Le Rotavac n'a fait l'objet d'aucun ECR dans les pays à faible mortalité infantile. En Inde, pays à forte mortalité, le Rotavac prévient probablement 57 % des cas graves de diarrhée à rotavirus (RR 0,43, IC à 95 % : 0,30 à 0,60 ; 6799 participants, données de valeur probante moyenne) ; l'essai n'a pas fait état de diarrhée grave toutes causes confondues à un an de suivi. Enfants vaccinés et suivis pendant deux ans Le Rotavac prévient probablement 54 % des cas graves de diarrhée à rotavirus en Inde (RR 0,46, IC à 95 % : 0,35 à 0,60 ; 6541 participants, 1 essai ; données de valeur probante moyenne) et 16 % des cas graves de diarrhée toutes causes confondues (RR 0,84, IC à 95 % : 0,71 à 0,98 ; 6799 participants, 1 essai ; données de valeur probante moyenne). Aucune augmentation du risque d'évènements indésirables graves (EIG) n'a été décelée (RR 0,93 95 % IC 0,85 à 1,02 ; données de valeur probante moyenne). Il y a eu huit cas d'invagination intestinale chez 5 764 enfants après la vaccination par Rotavac et trois cas chez 2 818 enfants après le placebo (RR 1,33, IC à 95 % : 0,35 à 5,02 ; données de très faible valeur probante). Il n'y avait pas suffisamment de données probante indiquant un effet sur la mortalité attribuable à un vaccin antirotavirus (198 381 participants, 44 essais ; données de valeur probante faible à très faible), car les essais n'étaient pas assez puissants pour détecter un effet à ce paramètre. CONCLUSIONS DES AUTEURS: Les vaccins RV1, RV5 et Rotavac préviennent les épisodes de diarrhée à rotavirus. Bien que l'estimation de l'effet relatif soit plus faible dans les pays à forte mortalité que dans les pays à faible mortalité, le nombre d'épisodes évités est plus élevé dans ces pays car le risque de base est beaucoup plus élevé. Nous n'avons trouvé aucun risque accru d'événements indésirables graves.

Day care attendance during the first 12 months of life and occurrence of infectious morbidities and symptoms.

OBJECTIVE: To investigate the occurrence of infectious morbidities according to day care attendance during the first year of life. METHODS: This was a cross-sectional analysis of data from the 12-month follow-up of a medium-sized city birth cohort from children born in 2015, in the Southern Brazil. Main exposure variables were day care attendance from 0 to 11 months of age, type of day care center (public or private), and age at entering day care. Health outcomes were classified as follows: "non-specific respiratory symptoms," "upper respiratory tract infection," "lower respiratory tract infection," "flu/cold," "diarrhea," or "no health problem," considering the two weeks prior to the interview administered at 12 months of life. Associations were assessed using Poisson regression adjusted by demographic, behavioral, and socioeconomic variables. RESULTS: The sample included 4018 children. Day care attendance was associated with all classifications of health outcomes mentioned above, except for flu/cold. These were stronger among children who entered day care at an age closer to the outcome time-point. An example are the results for lower respiratory tract infection and diarrhea, with adjusted prevalence ratios of 2.79 (95% CI: 1.67-4.64) and 2.04 (95% CI: 1.48-2.82), respectively, for those who entered day care after 8 months of age when compared with those who never attended day care. CONCLUSIONS: The present study consistently demonstrated the association between day care attendance and higher occurrence of infectious morbidities and symptoms at 12 months of life. Hence, measures to prevent infectious diseases should give special attention to children attending day care centers.

Predictive Factors of Diarrhea Preventive Practices by Caretakers.

BACKGROUND: Diarrhea is a leading cause of childhood mortality globally as well as in Nepal. Data all around the world has shown the highest prevalence of diarrheal disease amongst 6-12 months old children. This paper aims to assess the existing diarrhea preventive practices carried out by caretakers of children from 6-12 months of age and their predicting factors in Chitwan district of Nepal. METHODS: A cross -sectional survey was conducted among 384 caretakers of children aged 6-12 months from four different MCH clinics of Chitwan district, Nepal. Data were collected by using face- to-face interviews with structured questionnaires from April 15 to May 30, 2018. Univariate analysis, chi square, Pearson correlation and stepwise multiple regression analysis were the statistics used for data analysis. RESULTS: The findings showed that only around one-fourth (22.7%) of the caretakers followed good diarrhea preventive practices. Stepwise multiple regression showed that age, monthly family income, knowledge, attitude and accessibility to WASH (water, sanitation and hygiene), could predict the diarrhea preventive practices of caretakers by only 20.5%. Accessibility to WASH (beta= 0.246) had the highest predictive power and age (beta= 0.015) had the least predictive power of diarrhea preventive practices amongst them. CONCLUSIONS: The findings of this study suggest that there is a definite need to promote diarrhea preventive practices. Local government and non-government organizations should establish activities to improve accessibility to WASH, caretaker's attitude and caretaker's knowledge in order to ultimately improve their preventive practices.

Association of mother's handwashing practices and pediatric diarrhea: evidence from a multi-country study on community oriented interventions.

INTRODUCTION: Improved hand hygiene in contexts with high levels of diarrheal diseases has shown to reduce diarrheal episodes in children under five years. A quasi-experimental multi-country study with matched comparisons was conducted in four rural districts/sub districts in Cambodia, Guatemala, Kenya and Zambia. METHODS: Community oriented interventions including health promotion for appropriate hand washing was implemented in the intervention sites, through community health workers (CHW) and social accountability mechanisms. Community councils were strengthened/established in all study sites. Using household surveys, information on mother's handwashing practices and diarrhea incidence of children 2 weeks preceding the study was obtained. RESULTS AND CONCLUSION: Access to safe drinking water was reportedly higher for communities in Guatemala and Zambia (> 80%), than those in Cambodia and Kenya (< 63%), with significantly higher levels in intervention sites for Guatemala and Kenya. Improved sanitation was low (< 10%), for Kenya and Zambia, compared to Cambodia and Guatemala (> 40%); intervention sites reporting significantly higher levels, except for Zambia. Hand washing index; hand washing before food preparation, after defecation, attending to a child after defecation, and before feeding children was significantly higher for intervention sites in Cambodia, Guatemala and Kenya (Cambodia, 2.4 vs 2.2, p < 0.001, Guatemala, 3.0 vs 2.5, p < 0.001, Kenya, 2.6 vs 2.3, p < 0.001). Factors significantly associated with lower odds of diarrhea were; mother's marital status, higher educational status, one or more handwashing practices, wealthier quintiles, older (> 24 m), and female children. The findings suggest that caretaker handwashing with soap or ash has a protective effect on prevalence of diarrhea in children.

A randomized, open-labelled, non-inferiority phase 4 clinical trial to evaluate the immunogenicity and safety of the live, attenuated, oral rotavirus vaccine, ROTAVAC® in comparison with a licensed rotavirus vaccine in healthy infants.

BACKGROUND: ROTAVAC® (nHRV), derived naturally from the human 116E rotavirus (RV) neonatal strain, was licensed in India in 2015 based on promising results of a phase 3, safety and efficacy vaccine trial. As a pre-requisite for WHO prequalification, we compared the immunogenicity and safety of ROTAVAC® to those of a WHO-prequalified, Rotarix®. METHODS: We conducted a multicentre, open-labeled, randomized phase 4 clinical trial where 464 infants, 6-8 weeks of age were equally randomized to receive as licensed, the complete regimen of ROTAVAC® (3 doses; Group I) or Rotarix® (2 doses; Group II). Antibody responses (serum anti-RV Immunoglobulin A [IgA]) were measured by enzyme-linked immunosorbent assay (ELISA). The primary analysis was an assessment of non-inferiority of ROTAVAC® to Rotarix® for geometric mean concentration (GMC) for infants who received the complete regimen of either vaccine. RESULTS: The GMC for Group I was 20.4 (95%CI: 17.6, 23.6) and that for Group II was 24.8 (95%CI: 20.3, 30.3), the GMC ratio was 0.82 (95% CI: 0.64, 1.05), thus meeting the non-inferiority criterion. Site-wise analysis of GMC titres revealed that one site had a peculiar pre-vaccination titre affecting only ROTAVAC® post-vaccination GMCs. Seroconversion rates were 35.3% (95%CI: 29.0, 41.9) and 31.0% (95%CI: 25.1, 37.4) for Groups I and Group II, respectively. There was no substantive difference in safety profiles between both vaccines. CONCLUSIONS: The complete regimen of ROTAVAC® demonstrated immunological non-inferiority to the complete regimen of Rotarix® with a clinically acceptable safety profile. Because the demand for RV vaccines is increasing as more countries are expanding their immunization schedules, the lack of need of a buffering agent, low dose volume (0.5 mL), non-interference with other concomitantly administered vaccines, and conformance with WHO-prequalification requirements provide ROTAVAC® the potential for widespread global usage. Post completion of this study, ROTAVAC® is now a WHO-prequalified vaccine. CLINICAL TRIALS REGISTRATION: (CTRI Number: CTRI/2015/12/006428).

Vaccines for preventing rotavirus diarrhoea: vaccines in use.

BACKGROUND: Rotavirus results in more diarrhoea-related deaths in children under five years than any other single agent in countries with high childhood mortality. It is also a common cause of diarrhoea-related hospital admissions in countries with low childhood mortality. Rotavirus vaccines that have been prequalified by the World Health Organization (WHO) include a monovalent vaccine (RV1; Rotarix, GlaxoSmithKline), a pentavalent vaccine (RV5; RotaTeq, Merck), and, more recently, another monovalent vaccine (Rotavac, Bharat Biotech). OBJECTIVES: To evaluate rotavirus vaccines prequalified by the WHO (RV1, RV5, and Rotavac) for their efficacy and safety in children. SEARCH METHODS: On 4 April 2018 we searched MEDLINE (via PubMed), the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in the Cochrane Library), Embase, LILACS, and BIOSIS. We also searched the WHO ICTRP, ClinicalTrials.gov, clinical trial reports from manufacturers' websites, and reference lists of included studies and relevant systematic reviews. SELECTION CRITERIA: We selected randomized controlled trials (RCTs) in children comparing rotavirus vaccines prequalified for use by the WHO versus placebo or no intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility and assessed risks of bias. One review author extracted data and a second author cross-checked them. We combined dichotomous data using the risk ratio (RR) and 95% confidence interval (CI). We stratified the analysis by country mortality rate and used GRADE to evaluate evidence certainty. MAIN RESULTS: Fifty-five trials met the inclusion criteria and enrolled a total of 216,480 participants. Thirty-six trials (119,114 participants) assessed RV1, 15 trials (88,934 participants) RV5, and four trials (8432 participants) Rotavac.RV1 Children vaccinated and followed up the first year of life In low-mortality countries, RV1 prevents 84% of severe rotavirus diarrhoea cases (RR 0.16, 95% CI 0.09 to 0.26; 43,779 participants, 7 trials; high-certainty evidence), and probably prevents 41% of cases of severe all-cause diarrhoea (RR 0.59, 95% CI 0.47 to 0.74; 28,051 participants, 3 trials; moderate-certainty evidence). In high-mortality countries, RV1 prevents 63% of severe rotavirus diarrhoea cases (RR 0.37, 95% CI 0.23 to 0.60; 6114 participants, 3 trials; high-certainty evidence), and 27% of severe all-cause diarrhoea cases (RR 0.73, 95% CI 0.56 to 0.95; 5639 participants, 2 trials; high-certainty evidence).Children vaccinated and followed up for two yearsIn low-mortality countries, RV1 prevents 82% of severe rotavirus diarrhoea cases (RR 0.18, 95% CI 0.14 to 0.23; 36,002 participants, 9 trials; high-certainty evidence), and probably prevents 37% of severe all-cause diarrhoea episodes (rate ratio 0.63, 95% CI 0.56 to 0.71; 39,091 participants, 2 trials; moderate-certainty evidence). In high-mortality countries RV1 probably prevents 35% of severe rotavirus diarrhoea cases (RR 0.65, 95% CI 0.51 to 0.83; 13,768 participants, 2 trials; high-certainty evidence), and 17% of severe all-cause diarrhoea cases (RR 0.83, 95% CI 0.72 to 0.96; 2764 participants, 1 trial; moderate-certainty evidence).No increased risk of serious adverse events (SAE) was detected (RR 0.88 95% CI 0.83 to 0.93; high-certainty evidence). There were 30 cases of intussusception reported in 53,032 children after RV1 vaccination and 28 cases in 44,214 children after placebo or no intervention (RR 0.70, 95% CI 0.46 to 1.05; low-certainty evidence).RV5 Children vaccinated and followed up the first year of life In low-mortality countries, RV5 probably prevents 92% of severe rotavirus diarrhoea cases (RR 0.08, 95% CI 0.03 to 0.22; 4132 participants, 5 trials; moderate-certainty evidence). We did not identify studies reporting on severe all-cause diarrhoea in low-mortality countries. In high-mortality countries, RV5 prevents 57% of severe rotavirus diarrhoea (RR 0.43, 95% CI 0.29 to 0.62; 5916 participants, 2 trials; high-certainty evidence), but there is probably little or no difference between vaccine and placebo for severe all-cause diarrhoea (RR 0.80, 95% CI 0.58 to 1.11; 1 trial, 4085 participants; moderate-certainty evidence).Children vaccinated and followed up for two yearsIn low-mortality countries, RV5 prevents 82% of severe rotavirus diarrhoea cases (RR 0.18, 95% CI 0.08 to 0.39; 7318 participants, 4 trials; moderate-certainty evidence). We did not identify studies reporting on severe all-cause diarrhoea in low-mortality countries. In high-mortality countries, RV5 prevents 41% of severe rotavirus diarrhoea cases (RR 0.59, 95% CI 0.43 to 0.82; 5885 participants, 2 trials; high-certainty evidence), and 15% of severe all-cause diarrhoea cases (RR 0.85, 95% CI 0.75 to 0.98; 5977 participants, 2 trials; high-certainty evidence).No increased risk of serious adverse events (SAE) was detected (RR 0.93 95% CI 0.86 to 1.01; moderate to high-certainty evidence). There were 16 cases of intussusception in 43,629 children after RV5 vaccination and 20 cases in 41,866 children after placebo (RR 0.77, 95% CI 0.41 to 1.45; low-certainty evidence).Rotavac Children vaccinated and followed up the first year of life Rotavac has not been assessed in any RCT in countries with low child mortality. In India, a high-mortality country, Rotavac probably prevents 57% of severe rotavirus diarrhoea cases (RR 0.43, 95% CI 0.30 to 0.60; 6799 participants, moderate-certainty evidence); the trial did not report on severe all-cause diarrhoea at one-year follow-up.Children vaccinated and followed up for two yearsRotavac probably prevents 54% of severe rotavirus diarrhoea cases in India (RR 0.46, 95% CI 0.35 to 0.60; 6541 participants, 1 trial; moderate-certainty evidence), and 16% of severe all-cause diarrhoea cases (RR 0.84, 95% CI 0.71 to 0.98; 6799 participants, 1 trial; moderate-certainty evidence).No increased risk of serious adverse events (SAE) was detected (RR 0.93 95% CI 0.85 to 1.02; moderate-certainty evidence). There were eight cases of intussusception in 5764 children after Rotavac vaccination and three cases in 2818 children after placebo (RR 1.33, 95% CI 0.35 to 5.02; very low-certainty evidence).There was insufficient evidence of an effect on mortality from any rotavirus vaccine (198,381 participants, 44 trials; low- to very low-certainty evidence), as the trials were not powered to detect an effect at this endpoint. AUTHORS' CONCLUSIONS: RV1, RV5, and Rotavac prevent episodes of rotavirus diarrhoea. Whilst the relative effect estimate is smaller in high-mortality than in low-mortality countries, there is a greater number of episodes prevented in these settings as the baseline risk is much higher. We found no increased risk of serious adverse events.

Mothers' knowledge, attitude and practice towards the prevention and home-based management of diarrheal disease among under-five children in Diredawa, Eastern Ethiopia, 2016: a cross-sectional study.

BACKGROUND: Diarrhea remains the 2nd leading cause of death among children under 5 globally. It kills more young children than AIDS. It would have been prevented by simple home management using oral rehydration therapy. Mothers play a central role in its management and prevention. So, the main objective of this study was to assess mothers' knowledge, attitude & practice in prevention & home-based management of diarrheal disease among under-five children in Dire Dawa, Eastern Ethiopia. METHODS: Institutional based cross-sectional study was conducted from March 15-April 14, 2016, in Diredawa among 295 Mothers who had under-five child with diarrhea in the last 2 weeks using simple random sampling method. Mothers were interviewed face to face by using pretested, standard and structured questionnaire. The data quality was assured by translation, retranslation and pretesting the questionnaire. Data were checked for completeness, consistency and then entered into Epi Info v3.1 and analyzed using SPSS v20. The descriptive statistical analysis was used to compute frequency, percentages, and mean of the findings of this study. The results were presented using tables, charts, and graphs. RESULTS: In this study, 295 participants were included with 100% response rate. From total 295 mothers, around two-thirds (65.2%) of them had good knowledge, but more than half of mothers (54.9%) had a negative attitude towards home-based management and prevention of diarrhea among under-five children. Regarding the attitude of the mothers, 58% had poor practice towards home-based management and prevention of diarrhea among under-five children. CONCLUSION: The finding of this study showed that the attitude and practice of mothers were unsatisfactory about the prevention and home-based management of under-five diarrheal diseases. Therefore, Health education, dissemination of information, and community conversation should plan and implement to create a positive attitude and practice towards the better prevention and management of under 5 diarrheal diseases.

The geo-spatial distribution of childhood diarrheal disease in West Africa, 2008-2013: A covariate-adjusted cluster analysis.

Diarrhea is a major cause of morbidity and mortality among children in West Africa. To determine whether there are areas of heightened risk and if so, how they may be influenced by household and climatic variables, we describe the geo-spatial distribution of childhood diarrhea in ten countries of West Africa for the period 2008-2013 using data from Demographic and Health Surveys. The purely spatial scan statistic was applied, where the observed diarrhea cases were modeled as a Poisson variable and were compared to expected cases predicted from non-spatial logistic regression. Covariate-adjusted cluster analysis detected statistically significant clusters (p < 0.05) in ten cities and thirteen largely rural areas. Areas with particularly high relative risk included Cotonou, Benin (7.16), and Kaduna, Nigeria (7.21). The study demonstrates the importance of development and adaptation measures to protect child health, and that these interventions should be tailored to meet the needs of specific populations.

Promoting hygienic weaning food handling practices through a community-based programme: intervention implementation and baseline characteristics for a cluster randomised controlled trial in rural Gambia.

OBJECTIVE: Contamination of weaning food leads to diarrhoea in children under 5 years. Public health interventions to improve practices in low-income and middle-income countries are rare and often not evaluated using a randomised method. We describe an intervention implementation and provide baseline data for such a trial. DESIGN: Clustered randomised controlled trial. SETTING: Rural Gambia. PARTICIPANTS: 15 villages/clusters each with 20 randomly selected mothers with children aged 6-24 months per arm. INTERVENTION: To develop the public health intervention, we used: (A) formative research findings to determine theoretically based critical control point corrective measures and motivational drives for behaviour change of mothers; (B) lessons from a community-based weaning food hygiene programme in Nepal and a handwashing intervention programme in India; and (C) culturally based performing arts, competitions and environmental clues. Four intensive intervention days per village involved the existing health systems and village/cultural structures that enabled per-protocol implementation and engagement of whole villager communities. RESULTS: Baseline village and mother's characteristics were balanced between the arms after randomisation. Most villages were farming villages accessing health centres within 10 miles, with no schools but numerous village committees and representing all Gambia's three main ethnic groups. Mothers were mainly illiterate (60%) and farmers (92%); 24% and 10% of children under 5 years were reported to have diarrhoea and respiratory symptoms, respectively, in the last 7 days (dry season). Intervention process engaged whole village members and provided lessons for future implementation; culturally adapted performing arts were an important element. CONCLUSION: This research has potential as a new low-cost and broadly available public health programme to reduce infection through weaning food. The theory-based intervention was widely consulted in the Gambia and with experts and was well accepted by the communities. Baseline analysis provides socioeconomic data and confirmation of Unicefs Multiple Indicator Cluster Survey (MICS) data on the prevalence of diarrhoea and respiratory symptoms in the dry season in the poorest region of Gambia. TRIAL REGISTRATION NUMBER: PACTR201410000859336; Pre-results.