Maternal vaccination against COVID-19 and neonatal outcomes during Omicron: INTERCOVID-2022 study.

BACKGROUND: In early 2023, when Omicron was the variant of concern, we showed that vaccinating pregnant women decreased the risk for severe COVID-19-related complications and maternal morbidity and mortality. OBJECTIVE: This study aimed to analyze the impact of COVID-19 during pregnancy on newborns and the effects of maternal COVID-19 vaccination on neonatal outcomes when Omicron was the variant of concern. STUDY DESIGN: INTERCOVID-2022 was a large, prospective, observational study, conducted in 40 hospitals across 18 countries, from November 27, 2021 (the day after the World Health Organization declared Omicron the variant of concern) to June 30, 2022, to assess the effect of COVID-19 in pregnancy on maternal and neonatal outcomes and to assess vaccine effectiveness. Women diagnosed with laboratory-confirmed COVID-19 during pregnancy were compared with 2 nondiagnosed, unmatched women recruited concomitantly and consecutively during pregnancy or at delivery. Mother-newborn dyads were followed until hospital discharge. The primary outcomes were a neonatal positive test for COVID-19, severe neonatal morbidity index, severe perinatal morbidity and mortality index, preterm birth, neonatal death, referral to neonatal intensive care unit, and diseases during the neonatal period. Vaccine effectiveness was estimated with adjustment for maternal risk profile. RESULTS: We enrolled 4707 neonates born to 1577 (33.5%) mothers diagnosed with COVID-19 and 3130 (66.5%) nondiagnosed mothers. Among the diagnosed mothers, 642 (40.7%) were not vaccinated, 147 (9.3%) were partially vaccinated, 551 (34.9%) were completely vaccinated, and 237 (15.0%) also had a booster vaccine. Neonates of booster-vaccinated mothers had less than half (relative risk, 0.46; 95% confidence interval, 0.23-0.91) the risk of being diagnosed with COVID-19 when compared with those of unvaccinated mothers; they also had the lowest rates of preterm birth, medically indicated preterm birth, respiratory distress syndrome, and number of days in the neonatal intensive care unit. Newborns of unvaccinated mothers had double the risk for neonatal death (relative risk, 2.06; 95% confidence interval, 1.06-4.00) when compared with those of nondiagnosed mothers. Vaccination was not associated with any congenital malformations. Although all vaccines provided protection against neonatal test positivity, newborns of booster-vaccinated mothers had the highest vaccine effectiveness (64%; 95% confidence interval, 10%-86%). Vaccine effectiveness was not as high for messenger RNA vaccines only. Vaccine effectiveness against moderate or severe neonatal outcomes was much lower, namely 13% in the booster-vaccinated group (all vaccines) and 25% and 28% in the completely and booster-vaccinated groups, respectively (messenger RNA vaccines only). Vaccines were fairly effective in protecting neonates when given to pregnant women ≤100 days (14 weeks) before birth; thereafter, the risk increased and was much higher after 200 days (29 weeks). Finally, none of the neonatal practices studied, including skin-to-skin contact and direct breastfeeding, increased the risk for infecting newborns. CONCLUSION: When Omicron was the variant of concern, newborns of unvaccinated mothers had an increased risk for neonatal death. Neonates of vaccinated mothers had a decreased risk for preterm birth and adverse neonatal outcomes. Because the protective effect of COVID-19 vaccination decreases with time, to ensure that newborns are maximally protected against COVID-19, mothers should receive a vaccine or booster dose no more than 14 weeks before the expected date of delivery.

Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study.

BACKGROUND: In 2021, we showed an increased risk associated with COVID-19 in pregnancy. Since then, the SARS-CoV-2 virus has undergone genetic mutations. We aimed to examine the effects on maternal and perinatal outcomes of COVID-19 during pregnancy, and evaluate vaccine effectiveness, when omicron (B.1.1.529) was the variant of concern. METHODS: INTERCOVID-2022 is a large, prospective, observational study, involving 41 hospitals across 18 countries. Each woman with real-time PCR or rapid test, laboratory-confirmed COVID-19 in pregnancy was compared with two unmatched women without a COVID-19 diagnosis who were recruited concomitantly and consecutively in pregnancy or at delivery. Mother and neonate dyads were followed until hospital discharge. Primary outcomes were maternal morbidity and mortality index (MMMI), severe neonatal morbidity index (SNMI), and severe perinatal morbidity and mortality index (SPMMI). Vaccine effectiveness was estimated, adjusted by maternal risk profile. FINDINGS: We enrolled 4618 pregnant women from Nov 27, 2021 (the day after WHO declared omicron a variant of concern), to June 30, 2022: 1545 (33%) women had a COVID-19 diagnosis (median gestation 36·7 weeks [IQR 29·0-38·9]) and 3073 (67%) women, with similar demographic characteristics, did not have a COVID-19 diagnosis. Overall, women with a diagnosis had an increased risk for MMMI (relative risk [RR] 1·16 [95% CI 1·03-1·31]) and SPMMI (RR 1·21 [95% CI 1·00-1·46]). Women with a diagnosis, compared with those without a diagnosis, also had increased risks of SNMI (RR 1·23 [95% CI 0·88-1·71]), although the lower bounds of the 95% CI crossed unity. Unvaccinated women with a COVID-19 diagnosis had a greater risk of MMMI (RR 1·36 [95% CI 1·12-1·65]). Severe COVID-19 symptoms in the total sample increased the risk of severe maternal complications (RR 2·51 [95% CI 1·84-3·43]), perinatal complications (RR 1·84 [95% CI 1·02-3·34]), and referral, intensive care unit (ICU) admission, or death (RR 11·83 [95% CI 6·67-20·97]). Severe COVID-19 symptoms in unvaccinated women increased the risk of MMMI (RR 2·88 [95% CI 2·02-4·12]) and referral, ICU admission, or death (RR 20·82 [95% CI 10·44-41·54]). 2886 (63%) of 4618 total participants had at least a single dose of any vaccine, and 2476 (54%) of 4618 had either complete or booster doses. Vaccine effectiveness (all vaccines combined) for severe complications of COVID-19 for all women with a complete regimen was 48% (95% CI 22-65) and 76% (47-89) after a booster dose. For women with a COVID-19 diagnosis, vaccine effectiveness of all vaccines combined for women with a complete regimen was 74% (95% CI 48-87) and 91% (65-98) after a booster dose. INTERPRETATION: COVID-19 in pregnancy, during the first 6 months of omicron as the variant of concern, was associated with increased risk of severe maternal morbidity and mortality, especially among symptomatic and unvaccinated women. Women with complete or boosted vaccine doses had reduced risk for severe symptoms, complications, and death. Vaccination coverage among pregnant women remains a priority. FUNDING: None.

Principios básicos de ecografía pulmonar en neonatología / Basic notions of lung ultrasound in neonatology

La ecografía pulmonar (EP) ha ganado terreno en el diagnóstico de la mayoría de las patologías respiratorias presentes desde el nacimiento. Es altamente sensible a las variaciones del contenidode aire y fluidos pulmonares, y constituye un verdadero densitómetro del parénquimapulmonar con una sensibilidad superior a la de los estudios radiológicos. Es no invasiva, rápida, fácil de realizar junto a la cama del paciente y, a diferencia de la radiología convencional, no presenta riesgos de radiación. Además, nosproporciona información dinámica en tiempo real en una variedad de entornos neonatales y, al igual que las evaluaciones del corazón y el cerebro, puede ser realizada por el neonatólogo. El objetivo de esta publicación es mostrarlos principales artefactos e imágenes que sepueden encontrar en la EP neonatal, así como los diferentes patrones de aireación, y destacar su utilidad en el estudio de los trastornosrespiratorios más frecuentes del neonato.

Lung ultrasound (LU) has gained ground in the diagnosis of most respiratory conditions present since birth. It is highly sensitive to variations in air content and pulmonary fluids and functions as a true densitometer of the lung parenchyma with a sensitivity superior to that of radiological studies. A LU is a non-invasive, fast and easy tool that can be used at the patient's bedside and, unlike conventional radiology, does not pose risks of radiation. In addition, a LU provides real-time dynamic information in a variety of neonatal settings and, like heart and brain examinations, can be performed by the neonatologist. The objective of this article is to describe the main artifacts and images that can be found in the neonatal LU, as well as the different aeration patterns, and to highlight their usefulness in the study of the most frequent respiratory disorders of neonates.

Basic notions of lung ultrasound in neonatology. / Principios básicos de ecografía pulmonar en neonatología.

Lung ultrasound (LU) has gained ground in the diagnosis of most respiratory conditions present since birth. It is highly sensitive to variations in air content and pulmonary fluids and functions as a true densitometer of the lung parenchyma with a sensitivity superior to that of radiological studies. A LU is a non-invasive, fast and easy tool that can be used at the patient's bedside and, unlike conventional radiology, does not pose risks of radiation. In addition, a LU provides real-time dynamic information in a variety of neonatal settings and, like heart and brain examinations, can be performed by the neonatologist. The objective of this article is to describe the main artifacts and images that can be found in the neonatal LU, as well as the different aeration patterns, and to highlight their usefulness in the study of the most frequent respiratory disorders of neonates.

La ecografía pulmonar (EP) ha ganado terreno en el diagnóstico de la mayoría de las patologías respiratorias presentes desde el nacimiento. Es altamente sensible a las variaciones del contenido de aire y fluidos pulmonares, y constituye un verdadero densitómetro del parénquima pulmonar con una sensibilidad superior a la de los estudios radiológicos. Es no invasiva, rápida, fácil de realizar junto a la cama del paciente y, a diferencia de la radiología convencional, no presenta riesgos de radiación. Además, nos proporciona información dinámica en tiempo real en una variedad de entornos neonatales y, al igual que las evaluaciones del corazón y el cerebro, puede ser realizada por el neonatólogo. El objetivo de esta publicación es mostrar los principales artefactos e imágenes que se pueden encontrar en la EP neonatal, así como los diferentes patrones de aireación, y destacar su utilidad en el estudio de los trastornos respiratorios más frecuentes del neonato.

Factors associated with food insecurity among pregnant women assisted by Universal Health Care in Lavras - Minas Gerais State / Fatores associados à insegurança alimentar em gestantes atendidas na rede pública de saúde de Lavras - Minas Gerais

Abstract Objectives: to investigate sociodemographic and economic factors associated with food insecurity among pregnant women assisted by the universal healthcare network of Lavras, Minas Gerais. Methods: a cross-sectional study investigated socioeconomic and demographic, obstetric, and nutritional conditions experienced by pregnant women. Households in which pregnant women lived were classified as food secure or food insecure using the Brazilian Food Insecurity Scale. Prevalence estimates and prevalence ratios with 95% confidence intervals were generated to test for associations between food insecurity and several socioeconomic and demographic indicators using Poisson regression analysis. Results: among 173 pregnant women who participated in the study, 48% lived in households with some level of food insecurity. Adjusted models showed that pregnant women living in food-insecure households had higher prevalence ratios of lower education attainment (aPR = 1.43, CI95% = 1.07-1.91), woman being the head of the household (aPR = 1.39, CI95% = 1.02-1.87), having family monthly income lower than 1 ½ MW (aPR = 1.68, CI95% = 1.11-2.52) and participating in the government cash transfer program (aPR = 1.47, CI95% = 1.08-1.99). Conclusions: the high prevalence of food insecurity in pregnant women assisted by the public healthcare system was associated with structural social factors. Results of this study will contribute to develop an intersectoral health and nutrition policy in order to promote food security among marginalized communities and vulnerable populations, such as pregnant women.

Resumo Objetivos: investigar fatores sociodemográficos e econômicos associados à insegurança alimentar entre gestantes atendidas pelo sistema único de saúde de Lavras - Minas Gerais. Métodos: características socioeconômicas, demográficas, obstétricas e nutricionais de gestantes foram coletadas em estudo transversal. Os domicílios das gestantes foram classificados em segurança ou insegurança alimentar utilizando a Escala Brasileira de Insegurança Alimentar. Estimativas de prevalência e razão de prevalência com intervalos de confiança de 95%, testaram associações entre insegurança alimentar e indicadores socioeconômicos e demográficos utilizando modelos de Poisson. Resultados: entre as 173 gestantes participantes deste estudo, 48% viviam em domicílios com algum nível insegurança alimentar (IA). Modelos ajustados indicaram que gestantes em IAapresentaram maior prevalência de escolaridade inferior a oito anos de estudo (aRP = 1.39, IC95% = 1.07-1.91), ser chefe de família (aRP = 1.39, IC95% = 1.02-1.87), ter renda mensal inferior a 1½ salário mínimo (aRP = 1.68, IC95% =1.11-2.25), e ser participante do Bolsa Família (aRP = 1.47, IC95% = 1.08-1.99). Conclusão: a alta prevalência de insegurança alimentar em gestantes do sistema público de saúde de Lavras está associado a fatores socio-estruturais. Os resultados desta pesquisapoderão contribuir com o desenvolvimento de políticas intersetoriais de saúde e nutrição para a promoção da segurança alimentar entre comunidades marginalizadas e populações vulneráveis.

Factores de riesgo asociados a mortalidad en recién nacidos con hernia diafragmática congénita / Risk factors associated with mortality in newborn infants with congenital diaphragmatic hernia

Introducción. La hernia diafragmática congénita presenta alta morbimortalidad. Existen herramientas para predecir sobrevida, tanto prenatal (índice pulmón-cabeza observado/esperado ­observed/expected lung-to-head ratio; OE-LHR, por sus siglas en inglés­, presencia de hígado en tórax) como posnatal (puntaje del Grupo de Estudio sobre Hernia Diafragmática Congénita, Congenital Diaphragmatic Hernia Study Group, CDHSG). El objetivo fue identificar factores de riesgo asociados a mortalidad y estimar la mortalidad ajustada por riesgo prenatal en el subgrupo de pacientes con hernia izquierda aislada.Población y métodos. Estudio retrospectivo y analítico de pacientes nacidos en el Hospital Italiano de Buenos Aires durante 2011-2018. Se realizó un análisis multivariable para evaluar factores de riesgo asociados a mortalidad. Para la mortalidad ajustada por riesgo prenatal, se realizó una razón entre la mortalidad observada y la media "esperada" según el OE-LHR.Resultados. Se incluyeron 53 pacientes. La mediana de edad gestacional fue 38 semanas, y la media de peso al nacer, 3054 gramos. El 73 % de los pacientes tuvo hernia aislada. La mortalidad global fue del 45 %, mayor en pacientes con malformaciones asociadas. En el análisis multivariable, la presencia de hipertensión pulmonar grave estimada por ecocardiografía postnatal se asoció en forma independiente a mortalidad: (odds ratio ajustado 6,4; IC 95 %: 1,02-40). La mortalidad global observada en pacientes con hernia izquierda aislada fue similar a la esperada (razón 1,05).Conclusión. La mortalidad global es similar a la esperada según el OE-LHR. En nuestra población, la hipertensión pulmonar grave luego del nacimiento resultó determinante de la mortalidad.

Introduction. Morbidity and mortality are high in congenital diaphragmatic hernia. Some tools help to predict survival, both prenatally (observed/expected lung-to-head ratio [OE-LHR], presence of the liver in the chest) and postnatally (Congenital Diaphragmatic Hernia Study Group [CDHSG] score). Our objective was to identify the risk factors associated with mortality and estimate the risk-adjusted mortality in the prenatal period in the subgroup of patients with isolated left-sided hernia.Population and methods. Retrospective and analytical study of patients born at Hospital Italiano de Buenos Aires between 2011 and 2018. A multivariate analysis was done to assess mortality-associated risk factors. For risk-adjusted mortality in the prenatal period, the ratio between the observed mortality and the mean "expected" mortality based on the OE-LHR was estimated.Results. A total of 53 patients were included. Their median gestational age was 38 weeks, and their mean birth weight was 3054 g. Isolated hernia was observed in 73 % of patients. Overall mortality was 45 %, and higher in patients with associated malformations. In the multivariate analysis, the presence of severe pulmonary hypertension estimated by postnatal echocardiogram was independently associated with mortality (adjusted odds ratio: 6.4, 95 % confidence interval: 1.02-40). The observed overall mortality in patients with isolated left-sided hernia was similar to that expected (ratio: 1.05).Conclusion. Overall mortality was similar to that expected based on the OE-LHR. In our population, severe pulmonary hypertension after birth was a determining factor of mortality

Risk factors associated with mortality in newborn infants with congenital diaphragmatic hernia. / Factores de riesgo asociados a mortalidad en recién nacidos con hernia diafragmática congénita.

INTRODUCTION: Morbidity and mortality are high in congenital diaphragmatic hernia. Some tools help to predict survival, both prenatally (observed/expected lung-to-head ratio [OELHR], presence of the liver in the chest) and postnatally (Congenital Diaphragmatic Hernia Study Group [CDHSG] score). Our objective was to identify the risk factors associated with mortality and estimate the risk-adjusted mortality in the prenatal period in the subgroup of patients with isolated left-sided hernia. POULATION AND METHODS: Retrospective and analytical study of patients born at Hospital Italiano de Buenos Aires between 2011 and 2018. A multivariate analysis was done to assess mortality-associated risk factors. For riskadjusted mortality in the prenatal period, the ratio between the observed mortality and the mean "expected" mortality based on the OELHR was estimated. RESULTS: A total of 53 patients were included. Their median gestational age was 38 weeks, and their mean birth weight was 3054 g. Isolated hernia was observed in 73 % of patients. Overall mortality was 45 %, and higher in patients with associated malformations. In the multivariate analysis, the presence of severe pulmonary hypertension estimated by postnatal echocardiogram was independently associated with mortality (adjusted odds ratio: 6.4, 95 % confidence interval: 1.02-40). The observed overall mortality in patients with isolated left-sided hernia was similar to that expected (ratio: 1.05). CONCLUSION: Overall mortality was similar to that expected based on the OE-LHR. In our population, severe pulmonary hypertension after birth was a determining factor of mortality.

Introducción. La hernia diafragmática congénita presenta alta morbimortalidad. Existen herramientas para predecir sobrevida, tanto prenatal (índice pulmón-cabeza observado/ esperado ­observed/expected lung-to-head ratio; OE-LHR, por sus siglas en inglés­, presencia de hígado en tórax) como posnatal (puntaje del Grupo de Estudio sobre Hernia Diafragmática Congénita, Congenital Diaphragmatic Hernia Study Group, CDHSG). El objetivo fue identificar factores de riesgo asociados a mortalidad y estimar la mortalidad ajustada por riesgo prenatal en el subgrupo de pacientes con hernia izquierda aislada. Población y métodos. Estudio retrospectivo y analítico de pacientes nacidos en el Hospital Italiano de Buenos Aires durante 2011-2018. Se realizó un análisis multivariable para evaluar factores de riesgo asociados a mortalidad. Para la mortalidad ajustada por riesgo prenatal, se realizó una razón entre la mortalidad observada y la media "esperada" según el OE-LHR. Resultados. Se incluyeron 53 pacientes. La mediana de edad gestacional fue 38 semanas, y la media de peso al nacer, 3054 gramos. El 73 % de los pacientes tuvo hernia aislada. La mortalidad global fue del 45 %, mayor en pacientes con malformaciones asociadas. En el análisis multivariable, la presencia de hipertensión pulmonar grave estimada por ecocardiografía postnatal se asoció en forma independiente a mortalidad: (odds ratio ajustado 6,4; IC 95 %: 1,02- 40). La mortalidad global observada en pacientes con hernia izquierda aislada fue similar a la esperada (razón 1,05). Conclusión. La mortalidad global es similar a la esperada según el OE-LHR. En nuestra población, la hipertensión pulmonar grave luego del nacimiento resultó determinante de la mortalidad.