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.

Cord Blood SARS-CoV-2 IgG Antibodies and Their Association With Maternal Immunity and Neonatal Outcomes.

Passive transplacental immunity is crucial for neonatal protection from infections. Data on the correlation between neonatal immunity to SARS-CoV-2 and protection from adverse outcomes is scarce. This work aimed to describe neonatal seropositivity in the context of maternal SARS-CoV-2 infection, seropositivity, and neonatal outcomes. This retrospective nested case-control study enrolled high-risk pregnant women with a SARS-CoV-2 RT-PCR positive test who gave birth at the Instituto Nacional de Perinatología in Mexico City and their term neonates. Anti-SARS-CoV-2 IgG antibodies in maternal and cord blood samples were detected using a chemiluminescent assay. In total, 63 mother-neonate dyads (mean gestational age 38.4 weeks) were included. Transplacental transfer of SARS-CoV-2 IgG occurred in 76% of neonates from seropositive mothers. A positive association between maternal IgG levels and Cycle threshold (Ct) values of RT-qPCR test for SARS-CoV-2 with neonatal IgG levels was observed. Regarding neonatal outcomes, most seropositive neonates did not require any mechanical ventilation, and none developed any respiratory morbidity (either in the COVID-19 positive or negative groups) compared to 7 seronegative neonates. Furthermore, the odds of neonatal respiratory morbidity exhibited a tendency to decrease when neonatal IgG levels increase. These results add further evidence suggesting passive IgG transfer importance.

Evaluating the quality of the processes of care and clinical outcomes of premature newborns admitted to neonatal intensive care units in Mexico.

OBJECTIVES: To develop quality of care (QoC) indicators, evaluate the quality of the processes of care (QPC) and clinical outcomes, and analyze the association between the QPC and severe clinical outcomes of preterm newborns admitted to neonatal intensive care units (NICUs). DESIGN: Mixed methods approach: (1) development of QoC indicators via modified RAND/UCLA method; (2) cross-sectional study of QoC evaluation and (3) multiple logistic regression analysis to ascertain the association between the QPC and severe clinical outcomes. SETTING: Two NICUs belonged to the Mexican Institute of Social Security in Mexico City. PARTICIPANTS: About 489 preterm neonates (<37 weeks of gestation) without severe congenital anomalies. MAIN OUTCOME MEASURE(S): The QoC indicators; ≥60% of recommended QPC and severe clinical outcomes. RESULTS: The QoC included 10 QPC indicators across four domains: respiratory, nutrition and metabolism, infectious diseases, and screening, and five outcome indicators. The lower QPC indicators were for the nutrition and metabolism domain (17.8% started enteral feeding with human milk, and 20.7% received sodium bicarbonate appropriately). The higher QPC indicator was for the screening domain (97.6% of neonates <30 weeks gestation underwent early (≤14 days) transfontanelar ultrasound). The mean recommended QPC that neonates received was 47.5%. Only 26.6% of neonates received ≥60% of recommended QPC. About 60.7% of neonates developed severe clinical outcomes including mortality and healthcare-related major morbidity. Receiving ≥60% of recommended QPC was associated with a decrease of nearly half of odds of severe clinical outcomes. CONCLUSION: The evaluation of the QoC in NICUs is essential to address modifiable gaps in quality.

Monitoring the Postnatal Growth of Preterm Infants: A Paradigm Change.

There is no consensus regarding how the growth of preterm infants should be monitored or what constitutes their ideal pattern of growth, especially after term-corrected age. The concept that the growth of preterm infants should match that of healthy fetuses is not substantiated by data and, in practice, is seldom attained, particularly for very preterm infants. Hence, by hospital discharge, many preterm infants are classified as postnatal growth-restricted. In a recent systematic review, 61 longitudinal reference charts were identified, most with considerable limitations in the quality of gestational age estimation, anthropometric measures, feeding regimens, and how morbidities were described. We suggest that the correct comparator for assessing the growth of preterm infants, especially those who are moderately or late preterm, is a cohort of preterm newborns (not fetuses or term infants) with an uncomplicated intrauterine life and low neonatal and infant morbidity. Such growth monitoring should be comprehensive, as recommended for term infants, and should include assessments of postnatal length, head circumference, weight/length ratio, and, if possible, fat and fat-free mass. Preterm postnatal growth standards meeting these criteria are now available and may be used to assess preterm infants until 64 weeks' postmenstrual age (6 months' corrected age), the time at which they overlap, without the need for any adjustment, with the World Health Organization Child Growth Standards for term newborns. Despite remaining nutritional gaps, 90% of preterm newborns (ie, moderate to late preterm infants) can be monitored by using the International Fetal and Newborn Growth Consortium for the 21st Century Preterm Postnatal Growth Standards from birth until life at home.

Consideraciones sobre la publicación de dictámenes de los comités de bioética / Considerações sobre a publicação de pareceres dos comitês de bioética / Considerations on the publication of decisions by ethics committees

Este es un análisis sobre la forma en que la comunicación escrita puede llegar a ser una herramienta de influencia y legitimidad para los comités de ética. Se plantea a partir de una revisión histórica de documentos generados por diversos tipos de comités de ética, que han influido en toma de decisiones trascendentales en el ámbito médico, legal y social, y propone algunos factores a considerar en la estructuración de todo documento generado por los comités a partir de sus actividades, así como el contexto médico, científico, social y legal. Esta revisión y análisis histórico genera una lista de funciones que podrían tener las diversas publicaciones de los comités de bioética.

This is an analysis about the form in which written communication can become a tool of influence and legitimacy for ethics committees. It stems from a historical revision of documents generated by diverse types of ethics committees which have had an influence on transcendental decisions on the medical, legal, and social spheres and proposes some factors to be considered in every document generated by committees in their activities as well as the scientific, medical, social, and legal contexts. This review and the historical analysis generate a list of functions for the diverse publications of ethics committees.

Esta é uma análise sobre a forma pela qual a comunicação escrita pode chegar a ser uma ferramenta de influência e legitimidade para os comitês de ética. É suscitada a partir de uma revisão histórica de documentos gerados por diversos tipos de comitês de ética, que influiram na tomada de decisões transcendentais no âmbito médico, legal e social, e se propõe alguns fatores a serem considerados na estruturação de todo documento gerado pelos comitês a partir de suas atividades, no contexto médico, científico, social e legal. Esta revisão e análise histórica geram uma lista de funções que poderiam ter as diversas publicações dos comitês de bioética.