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1.
Pathogens ; 10(3)2021 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-33803104

RESUMO

Infections represent a serious health problem in neonates. Invasive Candida infections (ICIs) are still a leading cause of mortality and morbidity in neonatal intensive care units (NICUs). Infants hospitalized in NICUs are at high risk of ICIs, because of several risk factors: broad spectrum antibiotic treatments, central catheters and other invasive devices, fungal colonization, and impaired immune responses. In this review we summarize 19 published studies which provide the prevalence of previous surgery in neonates with invasive Candida infections. We also provide an overview of risk factors for ICIs after major surgery, fungal colonization, and innate defense mechanisms against fungi, as well as the roles of different Candida spp., the epidemiology and costs of ICIs, diagnosis of ICIs, and antifungal prophylaxis and treatment.

2.
Nutrients ; 13(2)2021 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-33573173

RESUMO

The trend toward using phytonutrients and/or nutraceuticals (P/Ns) with the aim of impacting immune health has increased in recent years. The main reason is that properties of P/Ns are associated with possible immunomodulating effects in the prevention and complementary treatment of viral diseases, including COVID-19 and other respiratory infections. In the present review, we assess the scientific plausibility of specific P/Ns for this purpose of preventative and therapeutic interventions against COVID-19, with an emphasis on safety, validity, and evidence of efficacy against other viruses. Five potential candidates have been identified after reviewing available studies (in silico, in vitro, and in vivo) in which certain flavonoids have demonstrated a potential for use as adjuvant therapeutic agents against viral infections, including COVID-19. As these are often better tolerated than pharmacological treatments, their use could be more widely considered if additional detailed studies can validate the existing evidence.


Assuntos
/tratamento farmacológico , Suplementos Nutricionais , Compostos Fitoquímicos/farmacologia , Humanos
4.
Am J Perinatol ; 37(S 02): S46-S53, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32898882

RESUMO

OBJECTIVE: We aimed at reviewing the currently available guidelines and scientific recommendations regarding the neonatal in-hospital management and feeding in the light of the coronavirus disease 2019 (COVID-19) pandemic. STUDY DESIGN: We systematically searched the guideline databases, Medline, Embase, and nationale/international neonatal societies websites as of June 19, 2020, for guidelines on neonatal management and feeding during the COVID-19 pandemic, at the same time assessing the methodological quality using the Appraisal of Guidelines for Research and Evaluation II tool. RESULTS: Eleven guidelines were included. The Chinese and American recommendations suggest separation of the mother and her neonate, whereas in French, Italian, UK, Canadian, and World Health Organization consensus documents the rooming-in is suggested, with Centers for Disease Control and Prevention guidelines suggesting to decide on a case-by-case basis. All the guidelines recommend breastfeeding or feeding with expressed maternal milk; the only exception is the Chinese recommendations, these last suggesting to avoid breastfeeding. CONCLUSION: This review may provide a useful tool for clinicians and organizers, highlighting differences and similarities of the existing guidelines on the management and feeding strategies in the light of the COVID-19 pandemic. KEY POINTS: · This study compares guidelines on management and nutrition of a newborn born to a mother with SARS-CoV-2 infection.. · Existing guidelines on neonatal management and nutrition during the SARS-CoV-2 pandemic show many differences.. · The majority of recommendations are mainly based on experts' opinion and are not evidence-based..


Assuntos
Aleitamento Materno/estatística & dados numéricos , Infecções por Coronavirus/epidemiologia , Fenômenos Fisiológicos da Nutrição do Lactente , Pneumonia Viral/epidemiologia , Guias de Prática Clínica como Assunto , Feminino , Humanos , Recém-Nascido , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Leite Humano , Pandemias , Organização Mundial da Saúde
5.
Am J Perinatol ; 37(S 02): S57-S60, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32898884

RESUMO

Neonatal adrenal hemorrhage (NAH) in newborn infants is a rare event that is associated with specific anatomical and vascular characteristics. It is more common in term infants and occurs more often in neonates who feature perinatal asphyxia. Symptoms that more frequently prompt to diagnosis are prolonged jaundice, detection of an abdominal mass, anemia, scrotal discoloration and/or swelling, hypotonia, lethargy, and hypertension. However, NAH may also occur without symptoms with its detection being occasional. Imaging through ultrasound scans is the cornerstone of diagnosis and follow-up monitoring over time. Here we report on a small NAH case series comprising three full-term, macrosomic infants who were born by vaginal delivery. The first and second ones showed clear signs of birth asphyxia, whereas the third was completely asymptomatic. In all three patients, only the right adrenal gland was involved, in line with what happens in 70% of cases. NAH is usually self-limiting and prone to a progressive resolution in a time ranging between 3 weeks and 6 months and so did in our three patients. KEY POINTS: · NAH is caused by perinatal asphyxia.. · It is diagnosed with addominal ultrasound.. · It is usually self-limiting..

6.
Am J Perinatol ; 37(S 02): S61-S65, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32898885

RESUMO

OBJECTIVE: This study aimed to describe a rare case of a serous borderline ovarian tumor (BOT) diagnosed during pregnancy in a 15-year old adolescent. RESULTS: The suspect of BOT was raised at a transvaginal ultrasound scan in early first trimester (at 5 weeks of amenorrhea), due to the presence of a moderately vascularized irregular papilla in the context of a unilocular low-level right ovarian cyst. The patient and her parents required termination of pregnancy, irrespective of the diagnosis of an ovarian lesion. After termination of pregnancy, the patient underwent laparoscopic enucleation of the ovarian mass, omentectomy, and peritoneal biopsies. No intra-abdominal spillage of the ovarian mass occurred, and the surgical specimens were put in an endobag and extracted transvaginally. Final pathological examination confirmed the diagnosis of a serous borderline ovarian tumor. The patient of free of disease after 8 months of follow-up. CONCLUSION: Although rare, borderline ovarian tumors can be diagnosed in an adolescent during pregnancy. The combination of specific sonographic assessment and minimally invasive conservative surgery appears as a very effective approach in this type of patient. KEY POINTS: · BOTs can occur in pregnant adolescents.. · Transvaginal ultrasound is crucial to suspect BOT.. · Laparoscopic conservative treatment is feasible..

7.
Am J Perinatol ; 37(S 02): S84-S88, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32898889

RESUMO

OBJECTIVE: Trial of labor after cesarean delivery (TOLAC) is a common practice worldwide but the evidence is still scant regarding this practice in women who underwent 2 previous cesareans. The purpose of this study is to retrospectively review our experience with vaginal birth after two previous cesarean sections (VBA2C), with specific attention to the indications for previous cesarean and to the women's motivation for attempting trial of labor. STUDY DESIGN: This was a retrospective cohort study conducted in a primary care hospital between January 2011 and December 2019. Inclusion criteria were: singleton pregnancies, absence of morphological abnormalities at ultrasonographic screening of the second trimester (or at any other stage of pregnancy), and two previous cesarean sections. RESULTS: The final analysis included 114 cases for maternal and neonatal outcomes. In total, 40.4% of women chose trial of labor after two cesarean delivery (TOLA2C group). TOLA2C was associated with a success rate of 76.1%, a higher gestational age at birth, and a shorter hospital stay, compared with elective repeated cesarean delivery group. There were no significant differences in the rate of Apgar scores at 5 minutes <7 between both groups. The percentage of successful TOLA2C in women with prior vaginal delivery was 92.8%. Factors related to failed TOLA2C included failure to progress (3/11, 27.3%), nonreassuring fetal heart rate (3/11, 27.3%), and no onset of spontaneous labor after premature rupture of membranes (5/11, 45.4%). In the group of TOLA2C, more than 70% accepted to travel more than 45 minutes to reach our hospital, with the aim to attempt VBA2C. CONCLUSION: TOLA2C is a possible option for both mothers and neonates in selected cases. Adequate counseling about pros and cons of TOLA2C is mandatory. The woman's motivation represents a key element to determine the success of VBA2C. KEY POINTS: · Selection of candidates and motivation of the patients represent key elements for successful TOLA2C.. · A careful record of obstetrical history and previous deliveries can provide clinicians useful information.. · Mode of delivery in women with two previous cesareans is strongly associated with doctor's counseling..

9.
Am J Perinatol ; 37(S 02): S26-S30, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32772357

RESUMO

There is growing evidence in medical literature to support an association between early-life respiratory syncytial virus lower respiratory tract-lower respiratory tract infection (RSV-LRTI) and recurrent wheezing/asthma-like symptoms. It has been estimated that children with a history of RSV-LRTI have a 2- to 12-fold higher risk of developing asthma. The connection between RSV infection and a developmental trajectory of reduced lung function remains throughout adolescence and early adulthood, suggesting a possible role for RSV even in the inception of chronic obstructive pulmonary disease. That is why the postnatal period appears to offer a specific window of opportunity for early intervention to prevent chronic obstructive lung diseases. The mechanisms by which RSV contributes to the onset of wheezing/asthma and lung function impairment are not fully understood but appear to relate to injury caused directly by the virus and/or to pre-existing predisposing factors. While awaiting a deeper understanding of the association between RSV and chronic lung diseases, the crucial role of pediatricians and physicians is to develop strategies to prevent RSV infections to try and protect children's lifelong respiratory health. KEY POINTS: · Several evidence suggest a link between RSV infection in early life and wheezing/asthma development.. · RSV infection appears to have long term respiratory effects.. · The prevention of RSV infections could reduce the incidence of chronic obstructive respiratory diseases..

10.
Am J Perinatol ; 37(S 02): S31-S38, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32757186

RESUMO

In spite of the increasing, accumulating knowledge on the novel pandemic coronavirus severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), questions on the coronavirus disease-2019 (COVID-19) infection transmission from mothers to fetuses or neonates during pregnancy and peripartum period remain pending and have not been addressed so far. SARS-CoV-2, a RNA single-stranded virus, has been detected in the amniotic fluid, in the cord blood and in the placentas of the infected women. In the light of these findings, the theoretical risk of intrauterine infection for fetuses, or of peripartum infection occurring during delivery for neonates, has a biological plausibility. The extent of this putative risk might, however, vary during the different stages of pregnancy, owing to several variables (physiological modifications of the placenta, virus receptors' expression, or delivery route). This brief review provides an overview of the current evidence in this area. Further data, based on national and international multicenter registries, are needed not only to clearly assess the extent of the risk for vertical transmission, but also to ultimately establish solid guidelines and consistent recommendations. KEY POINTS: · Questions on the COVID-19 infection transmission from mothers to fetuses or neonates during pregnancy and peripartum period remain pending so far.. · The theoretical risk of intrauterine infection for fetuses, or of neonatal infection during delivery for neonates, has a biological plausibility.. · A caution is recommended in the interpretation of clinical and laboratory data in neonates..


Assuntos
Infecções por Coronavirus/prevenção & controle , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Cuidado Pós-Natal/métodos , Complicações Infecciosas na Gravidez/prevenção & controle , Betacoronavirus , Parto Obstétrico , Feminino , Humanos , Recém-Nascido , Gravidez
11.
N Engl J Med ; 383(5): 415-425, 2020 07 30.
Artigo em Inglês | MEDLINE | ID: mdl-32726528

RESUMO

BACKGROUND: Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection in infants, and a need exists for prevention of RSV in healthy infants. Nirsevimab is a monoclonal antibody with an extended half-life that is being developed to protect infants for an entire RSV season with a single intramuscular dose. METHODS: In this trial conducted in both northern and southern hemispheres, we evaluated nirsevimab for the prevention of RSV-associated lower respiratory tract infection in healthy infants who had been born preterm (29 weeks 0 days to 34 weeks 6 days of gestation). We randomly assigned the infants in a 2:1 ratio to receive nirsevimab, at a dose of 50 mg in a single intramuscular injection, or placebo at the start of an RSV season. The primary end point was medically attended RSV-associated lower respiratory tract infection through 150 days after administration of the dose. The secondary efficacy end point was hospitalization for RSV-associated lower respiratory tract infection through 150 days after administration of the dose. RESULTS: From November 2016 through November 2017, a total of 1453 infants were randomly assigned to receive nirsevimab (969 infants) or placebo (484 infants) at the start of the RSV season. The incidence of medically attended RSV-associated lower respiratory tract infection was 70.1% lower (95% confidence interval [CI], 52.3 to 81.2) with nirsevimab prophylaxis than with placebo (2.6% [25 infants] vs. 9.5% [46 infants]; P<0.001) and the incidence of hospitalization for RSV-associated lower respiratory tract infection was 78.4% lower (95% CI, 51.9 to 90.3) with nirsevimab than with placebo (0.8% [8 infants] vs. 4.1% [20 infants]; P<0.001). These differences were consistent throughout the 150-day period after the dose was administered and across geographic locations and RSV subtypes. Adverse events were similar in the two trial groups, with no notable hypersensitivity reactions. CONCLUSIONS: A single injection of nirsevimab resulted in fewer medically attended RSV-associated lower respiratory tract infections and hospitalizations than placebo throughout the RSV season in healthy preterm infants. (Funded by AstraZeneca and Sanofi Pasteur; ClinicalTrials.gov number, NCT02878330.).


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais/administração & dosagem , Antivirais/administração & dosagem , Recém-Nascido Prematuro , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Vírus Sincicial Respiratório Humano , Infecções Respiratórias/prevenção & controle , Proteínas Virais de Fusão/antagonistas & inibidores , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Antivirais/efeitos adversos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Lactente , Recém-Nascido , Injeções Intramusculares , Estimativa de Kaplan-Meier , Masculino , Distribuição de Poisson , Infecções por Vírus Respiratório Sincicial/epidemiologia , Infecções Respiratórias/epidemiologia , Infecções Respiratórias/virologia
14.
Am J Perinatol ; 37(8): 780-791, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32359226

RESUMO

The novel coronavirus disease 2019 (COVID-19) pandemic has urged the development and implementation of guidelines and protocols on diagnosis, management, infection control strategies, and discharge planning. However, very little is currently known about neonatal COVID-19 and severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infections. Thus, many questions arise with regard to respiratory care after birth, necessary protection to health care workers (HCW) in the delivery room and neonatal intensive care unit (NICU), and safety of bag and mask ventilation, noninvasive respiratory support, deep suctioning, endotracheal intubation, and mechanical ventilation. Indeed, these questions have created tremendous confusion amongst neonatal HCW. In this manuscript, we comprehensively reviewed the current evidence regarding COVID-19 perinatal transmission, respiratory outcomes of neonates born to mothers with COVID-19 and infants with documented SARS-CoV-2 infection, and the evidence for using different respiratory support modalities and aerosol-generating procedures in this specific population. The results demonstrated that to date, neonatal COVID-19 infection is uncommon, generally acquired postnatally, and associated with favorable respiratory outcomes. The reason why infants display a milder spectrum of disease remains unclear. Nonetheless, the risk of severe or critical illness in young patients exists. Currently, the recommended respiratory approach for infants with suspected or confirmed infection is not evidence based but should include all routinely used types of support, with the addition of viral filters, proper personal protective equipment, and placement of infants in isolation rooms, ideally with negative pressure. As information is changing rapidly, clinicians should frequently watch out for updates on the subject. KEY POINTS: · Novel coronavirus disease 2019 (COVID-19) pandemic urged development of guidelines.. · Neonatal COVID-19 disease is uncommon.. · Respiratory outcomes in neonates seems favorable.. · Current neonatal respiratory care should continue.. · Clinicians should watch frequently for updates..


Assuntos
Manuseio das Vias Aéreas , Infecções por Coronavirus , Doenças do Recém-Nascido , Controle de Infecções , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Pandemias , Pneumonia Viral , Manuseio das Vias Aéreas/métodos , Manuseio das Vias Aéreas/tendências , Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/terapia , Prática Clínica Baseada em Evidências , Feminino , Humanos , Recém-Nascido , Doenças do Recém-Nascido/epidemiologia , Doenças do Recém-Nascido/prevenção & controle , Doenças do Recém-Nascido/terapia , Doenças do Recém-Nascido/virologia , Controle de Infecções/métodos , Controle de Infecções/organização & administração , Controle de Infecções/normas , Pandemias/prevenção & controle , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Pneumonia Viral/terapia , Gravidez
16.
Lancet Child Adolesc Health ; 4(6): 444-454, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32407710

RESUMO

BACKGROUND: Very low birthweight or preterm infants are at increased risk of adverse outcomes including sepsis, necrotising enterocolitis, and death. We assessed whether supplementing the enteral diet of very low-birthweight infants with lactoferrin, an antimicrobial protein, reduces all-cause mortality or major morbidity. METHODS: We did a multicentre, double-blind, pragmatic, randomised superiority trial in 14 Australian and two New Zealand neonatal intensive care units. Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using minimising web-based randomisation to receive once daily 200 mg/kg pasteurised bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks' post-menstrual age (or for 2 weeks, if longer), or until discharge from the study hospital if that occurred first. Designated nurses preparing the daily feeds were not masked to group assignment, but other nurses, doctors, parents, caregivers, and investigators were unaware. The primary outcome was survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks' post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population. Safety analyses were by treatment received. We also did a prespecified, PRISMA-compliant meta-analysis, which included this study and other relevant randomised controlled trials, to estimate more precisely the effects of lactoferrin supplementation on late-onset sepsis, necrotising enterocolitis, and survival. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12611000247976. FINDINGS: Between June 27, 2014, and Sept 1, 2017, we recruited 1542 infants; 771 were assigned to the intervention group and 771 to the control group. One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis. In-hospital death or major morbidity occurred in 162 (21%) of 770 infants in the intervention group and in 170 (22%) of 771 infants in the control group (relative risk [RR] 0·95, 95% CI 0·79-1·14; p=0·60). Three suspected unexpected serious adverse reactions occurred; two in the lactoferrin group, namely unexplained late jaundice and inspissated milk syndrome, but were not attributed to the intervention and one in the control group had fatal inspissated milk syndrome. Our meta-analysis identified 13 trials completed before Feb 18, 2020, including this Article, in 5609 preterm infants. Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I2=58%), but not necrotising enterocolitis or all-cause mortality. INTERPRETATION: Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants. Future collaborative studies should use products with demonstrated biological activity, be large enough to detect moderate and clinically important effects reliably, and assess greater doses of lactoferrin in infants at increased risk, such as those not exclusively receiving breastmilk or infants of extremely low birthweight. FUNDING: Australian National Health and Medical Research Council.


Assuntos
Cuidados Críticos/métodos , Suplementos Nutricionais , Mortalidade Hospitalar/tendências , Recém-Nascido de muito Baixo Peso , Unidades de Terapia Intensiva Neonatal , Lactoferrina/efeitos adversos , Austrália , Causas de Morte , Bases de Dados Factuais , Método Duplo-Cego , Feminino , Humanos , Recém-Nascido , Lactoferrina/administração & dosagem , Masculino , Morbidade , Nova Zelândia , Análise de Sobrevida
17.
Pediatr Infect Dis J ; 39(5): 438-443, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32301920

RESUMO

BACKGROUND: Suspected early-onset sepsis (EOS) results in antibiotic treatment of a substantial number of neonates who are uninfected. We evaluated if an approach using serial physical examinations (SPEs) can reduce antibiotic exposure for suspected EOS in term neonates during the first 3 days of life, without affecting safety. METHODS: Within a quality-improvement framework, SPEs for 24-48 hours for neonates with suspected EOS was implemented in the neonatal intensive care unit, Stavanger, Norway. The proportion of neonates ≥37 weeks gestation exposed to antibiotics, antibiotic therapy-days and the safety outcome time from birth to start antibiotics were compared between a baseline period (April 2014-February 2016), when a risk factor based approach was used, and a post-SPE-implementation period (January 2017-November 2018). RESULTS: We included all term live born neonates (n = 17,242) in the 2 periods. There was a 57% relative reduction in neonates exposed to antibiotics; 2.9% in the baseline and 1.3% in the post-implementation period, P < 0.001. There was a 60% relative reduction in mean antibiotic therapy-days/1000 patient-days; from 320 to 129, P < 0.001, and a 50% relative reduction in time to initiate antibiotics in suspected EOS-cases, from median (interquartile range) 14 (5-28) to 7 (3-17) hours, P = 0.003. The incidence of culture-positive EOS remained unchanged. There were no infection-attributable deaths. CONCLUSIONS: Implementing SPE to guide empiric antibiotic therapy in term neonates with suspected EOS more than halved the burden of antibiotic exposure, without delay of antibiotic treatment of infected neonates or increased sepsis-related mortality.

19.
Vaccine ; 38(8): 2105-2114, 2020 02 18.
Artigo em Inglês | MEDLINE | ID: mdl-31776027

RESUMO

BACKGROUND: Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization. METHODS: This phase IV, multi-country, open-label study assessed the immunogenicity and safety of infant primary vaccination with DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13). Enrolled infants (6-14 weeks old) were born to mothers who were randomized to receive reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) during pregnancy (270/7-366/7 weeks' gestation) with crossover immunization postpartum. All infants received 2 or 3 DTaP-HepB-IPV/Hib and PCV13 doses according to national schedules. Immunogenicity was assessed in infants pre- and 1 month post-primary vaccination. The primary objective was to assess seroprotection/vaccine response rates for DTaP-HepB-IPV/Hib antigens 1 month post-primary vaccination. RESULTS: 601 infants (Tdap group: 296; control group: 305) were vaccinated. One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups. Vaccine response rates for pertussis antigens were significantly lower in infants whose mothers received pregnancy Tdap (37.5-77.1%) versus placebo (90.0-99.2%). Solicited and unsolicited adverse event rates were similar between groups. Serious adverse events occurred in 2.4% (Tdap group) and 5.6% (control group) of infants, none were vaccination-related. CONCLUSIONS: Pertussis antibodies transferred during pregnancy may decrease the risk of pertussis infection in the first months of life but interfere with the infant's ability to produce pertussis antibodies, the clinical significance of which remains unknown. Safety and reactogenicity results were consistent with previous experience. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02422264.

20.
Vaccine ; 38(8): 2095-2104, 2020 02 18.
Artigo em Inglês | MEDLINE | ID: mdl-31776029

RESUMO

BACKGROUND: Pertussis immunization during pregnancy is recommended in many countries. Data from large randomized controlled trials are needed to assess the immunogenicity, reactogenicity and safety of this approach. METHODS: This phase IV, observer-blind, randomized, placebo-controlled, multicenter trial assessed immunogenicity, transplacental transfer of maternal pertussis antibodies, reactogenicity and safety of a reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap) during pregnancy. Women received Tdap or placebo at 27-36 weeks' gestation with crossover ≤ 72-hour-postpartum immunization. Immune responses were assessed before the pregnancy dose and 1 month after, and from the umbilical cord at delivery. Superiority (primary objective) was reached if the lower limits of the 95% confidence intervals (CIs) of the pertussis geometric mean concentration (GMC) ratios (Tdap/control) in cord blood were ≥ 1.5. Solicited and unsolicited adverse events (AEs) and pregnancy-/neonate-related AEs of interest were recorded. RESULTS: 687 pregnant women were vaccinated (Tdap: N = 341 control: N = 346). Superiority of the pertussis immune response (maternally transferred pertussis antibodies in cord blood) was demonstrated by the GMC ratios (Tdap/control): 16.1 (95% CI: 13.5-19.2) for anti-filamentous hemagglutinin, 20.7 (15.9-26.9) for anti-pertactin and 8.5 (7.0-10.2) for anti-pertussis toxoid. Rates of pregnancy-/neonate-related AEs of interest, solicited general and unsolicited AEs were similar between groups. None of the serious AEs reported throughout the study were considered related to maternal Tdap vaccination. CONCLUSIONS: Tdap vaccination during pregnancy resulted in high levels of pertussis antibodies in cord blood, was well tolerated and had an acceptable safety profile. This supports the recommendation of Tdap vaccination during pregnancy to prevent early-infant pertussis disease. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02377349.

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