[Effectiveness of the vagino-rectal exudate self-sampling for prenatal screening of Streptococcus agalactiae infection. GALL study]. / Efectividad de la autotoma del exudado vaginorrectal para el cribado prenatal de la infección por Streptococcus agalactiae. Estudio GALL.

OBJETIVE: To evaluate the effectiveness of vagino-rectal swab autotomy for prenatal screening for GBS infection and to identify the barriers and facilitators encountered by the pregnant woman for this intervention. DESIGN: Cross-sectional study of diagnostic tests. PARTICIPANTS AND SITE: A total of 213 pregnant women who attended the primary care midwife's office in 6 health centers of the Basque Health Service/Osakidetza in Bizkaia, who met the inclusion criteria and agreed to participate in the study, participated in the study. MAIN MEASUREMENTS: The result of the vagino-rectal culture obtained by the pregnant woman was compared with the result of the vagino-rectal culture taken by the midwife in consultation on the same day, and the barriers and facilitators encountered by the women in the self-test were collected. RESULTS: Self-testing as a test for GBS was found to have a sensitivity of 93.3% (95% CI 78.7-98.2), a specificity of 99.4% (95% CI 96.5-99.9), a positive predictive value of 96% (95% CI 82.8-99.4) and a negative predictive value of 98.8% (95% CI 95.6-99.7). 27.3% of respondents encountered some difficulty in the collection, only 4.8% did not feel qualified, 84.2% felt comfortable, 99.5% considered the information provided to be adequate and complete, 94.7% did not find the steps to follow complicated, and 96% were satisfied with the study. CONCLUSIONS: Self-collection of vagino-rectal exudate for GBS detection has proved to be valid and reliable, which would make it possible to offer this option to pregnant women in the systematic screening for GBS infection.

[Group B streptococcal early-onset neonatal sepsis in the area of Barcelona (2004-2010). Analysis of missed opportunities for prevention]. / Evolución de la sepsis neonatal precoz por Streptococcus agalactiae en el área de Barcelona (2004-2010). Análisis de los fallos del cumplimiento del protocolo de prevención.

OBJECTIVES: To study the evolution of the incidence of early-onset neonatal sepsis (EOS) by Streptococcus agalactiae in the area of Barcelona and to analyze failure of compliance with the prevention protocol. METHODS: A retrospective review was carried out on EOS cases in 8 Health-Care Centers in the Barcelona area between 2004 and 2010. RESULTS: Forty-nine newborns from 48 mothers were diagnosed with EOS. The incidence was 0.29‰ living newborns (0.18-0.47‰), with no significant differences in the fluctuations along the 7 years. The mortality rate was 8.16%. In 68.5% cases the maternal colonization studies were negative, and in 21% these studies were not performed. No risk factors were detected in 58.3% of pregnant women, and 22.9% of births were premature. In 58% of cases intra-partum antibiotic prophylaxis was not administered because it was not indicated, and in 42% due to failure to follow the protocol (3 strains were resistant to erythromycin). Resistance to clindamycin was 33.3%. The Streptococcus agalactiae serotypes more frequently isolated were iii, v, and ia. CONCLUSIONS: No significant changes were detected in the incidence of Streptococcus agalactiae EOS in the 7 years of the study. The increased sensitivity of screening methods with the use of molecular techniques, the performance of susceptibility testing of strains isolated from pregnant women, and the improvement of communication between Health-Care Centers, can contribute to a better implementation of the protocol, as well as to reduce the incidence of EOS.

[Clinical observation of newborns with infection risk: A safe practice]. / Observación clínica de recién nacidos con factores de riesgo infeccioso, una práctica segura.

INTRODUCTION: Early-onset neonatal sepsis refers to an infection which starts during the first 72hours of birth, and can lead to significant morbidity and mortality. Scientific evidence shows that infected infants present with symptoms during the first hours after delivery. There has been a significant decrease in this condition with the implementation of guidelines for its prevention. However, International guidelines still recommend the evaluation of these infants using painful tests. MATERIAL AND METHODS: A prospective cohort study was conducted on all asymptomatic infants born at>35 weeks gestation with one or more risk factors in a single tertiary care centre from 2011 to 2015. They were periodically observed in newborn nursery from admission until discharge looking for signs of infection. RESULTS: Out of the 9,424 babies born during this period, 1425 were included in the study. A total of 53 infants were admitted to the neonatal unit, half of them because of sepsis suspicion. Finally, just 7 were discharged with the diagnosis of sepsis. All these 7 presented with symptoms during their first 72hours of life. No sepsis was reported in asymptomatic infants. CONCLUSIONS: Truly infected infants present with symptoms during their first hours of life. This study supports the observation of infants at risk as a safe practice to detect early-onset sepsis.

[Cord blood procalcitonin in the assessment of early-onset neonatal sepsis]. / Procalcitonina en sangre de cordón en la valoración del riesgo de sepsis neonatal precoz.

INTRODUCTION: Early diagnosis of early-onset neonatal sepsis (EONS) is essential to reduce morbidity and mortality. Procalcitonin (PCT) in cord blood could provide a diagnosis of infected patients from birth. OBJECTIVE: To study the usefulness and safety of a procedure for the evaluation of newborns at risk of EONS, based on the determination of PCT in cord blood. PATIENTS AND METHODS: Neonates with infectious risk factors, born in our hospital from October 2013 to January 2015 were included. They were processed according to an algorithm based on the values of cord blood procalcitonin (< 0.6ng/ml versus ≥0.6ng/ml). They were later classified as proved infection, probable, or no infection. RESULTS AND CONCLUSIONS: Of the 2,519 infants born in the study period, 136 met inclusion criteria. None of 120 cases with PCT<0.6ng/ml in cord blood developed EONS (100% negative predictive value). On the other hand, of the 16 cases with PCT ≥0.6ng/ml, 10 were proven or probably infected (62.5% positive predictive value). The sensitivity of the PCT against infection was 100%, with a specificity of 95.2% (area under the receiver operator curve 0.969). The incidence of infection in the study group was 7.4%, and 26.1% in cases with maternal chorioamnionitis. 21 newborn (15.4%) received antibiotic therapy. The studied protocol has shown to be effective and safe to differentiate between patients with increased risk of developing an EONS, in those where the diagnostic and therapeutic approach was more interventionist, versus those with less likelihood of sepsis, who would benefit from a more conservative management.

Colonización vaginal/rectal por Streptococcus agalactiae en gestantes de Melena del Sur, Cuba / Vaginal and rectal Streptococcus agalactiae colonization in pregnant women from Melena del Sur municipality in Cuba

Introducción: en Cuba se desconoce el peso de la colonización vaginal o rectal por Streptococcus agalactiae o estreptococo ß-hemolítico grupo B (SGB) como factor de riesgo para el desarrollo de sepsis neonatal precoz. Objetivo: determinar la prevalencia de colonización vaginal/rectal por SGB entre la población de gestantes del municipio Melena del Sur, Mayabeque. Métodos: se realizó un estudio observacional de corte transversal entre febrero-agosto 2011, en el que se incluyeron 120 gestantes (35-37 semanas). Se obtuvieron muestras vaginales y rectales que se cultivaron en caldo Todd Hewitt y medio Granada y se calculó la sensibilidad y especificidad de ambos medios de cultivo para la recuperación de SGB. Se hizo seguimiento de las embarazadas hasta el momento del parto para conocer acerca de la aparición de factores de riesgo para el desarrollo de sepsis neonatal, sobre la imposición de profilaxis antibiótica intraparto y si se produjeron casos de sepsis neonatal (tipo y evolución). Resultados: la especificidad lograda con el medio Granada para el aislamiento de SGB fue superior (94,57 %) pero la sensibilidad fue de solo 60,71 %; la combinación de su empleo y el caldo Todd Hewitt permitió la demostración de colonización por SGB en el 27,5 % de las gestantes. Se constató la administración de tratamiento profiláctico a las embarazas colonizadas en las que se presentaron factores de riesgo en el momento del parto y se produjeron solo cuatro casos de sepsis neonatales, lo que realza el valor de esta estrategia en la intercepción de la transmisión vertical.

Introduction: the impact of vaginal or rectal colonization by Streptococcus agalactiae or group B hemolytic streptococcus as risk factor for the development of early neonatal sepsis is still unknown in Cuba. Objective: to determine the prevalence of group B hemolytic streptococcus colonization of the vagina and the rectum among the pregnant women of the Melena del Sur municipality in Mayabeque province, Cuba. Methods: observational and cross-sectional study conducted from February to August 2011, which covered 120 pregnant women (35 to 37 weeks of gestation). Vaginal and rectal samples were taken to be cultured in ToodHewitt broth and grenade medium and the sensitivity and specificity of both culturing media were then calculated for recovery of Group B hemolytic streptococcus. The pregnant women were followed-up up to the delivery time so as to learn about the occurrence of risk factors for developing neonatal sepsis, the application of antibiotic prophylaxis intrapartum and the occurrence of cases of neonatal sepsis (type and progress). Results: the specificity of the grenade medium for Group B streptococcus was higher (94.57 %), but sensitivity was just 60.71 %. The combination of grenade medium plus Todd Hewitt broth allowed showing the Group B hemolytic streptococcus colonization in 27.5 % of pregnant women. It was then confirmed that prophylactic treatment was given to colonized pregnant women who presented with risk factors at the time of delivery and that there were just four neonatal sepsis cases, which stressed the value of this strategy in halting the vertical transmission.

Profilaxis de sepsis neonatal por Streptococcus Agalactiae (grupo B) basada en vacunas: revisión de la literatura / Prophylaxis of early neonatal sepsis Streptococcus Agalactiae (group B) based on vaccines: literature review

El Streptococcus agalactiae o grupo B (SGB), es el principal agente de sepsis neonatal precoz. A pesar de los intentos de prevención de esta infección, aún no se logra la efectividad esperada. Es por esto que se ha intentado desarrollar una vacuna que pueda prevenir la mayoría de las patologías que esta bacteria produce, incluyendo la sepsis neonatal precoz y tardía. De esta manera se evitarían las limitaciones actuales de la profilaxis antibiótica. Los intentos de crear una vacuna han incluido la utilización de polisacáridos del SGB tanto puros como asociados a proteínas como el toxoide tetánico. También, se han usado proteínas específicas de la cápsula que tienen potencial efectividad como factores inmunogénicos. Las vacunas conjugadas son las más estudiadas en la actualidad, habiendo completado estudios clínicos en fase II, tanto en adultos sanos como en embarazadas. Al ser la sepsis neonatal una complicación grave aún no controlada óptimamente, la creación de una vacuna contra este patógeno sería de gran impacto en salud pública. Se presentan los diferentes tipos de vacunas desarrolladas y el estado de avance en el que se encuentran.

Streptococcus agalactiae or group B, is the mayor causing agent of early onset neonatal sepsis. Although mayor prevention strategies have been made, the expected effectiveness hasn't been achieved. That's why efforts have been made to develop a vaccine that can prevent most of the diseases these bacteria can produce, including early and late onset neonatal sepsis. These way, actual antibiotic prophylaxis limitations can be avoided. Attempts include the utilization of Streptococcus group B polysaccharides in their pure state or combined with proteins as tetanic toxoid. Specific capsule proteins have been used also because of their potential effectiveness as inmunogenic factors. Overall vaccines conjugated ones are the most studied, having completed phase II clinical trials in healthy adults and pregnant women. Neonatal sepsis is a severe complication that has not been controlled yet, so the creation of a vaccine against this pathogen would be of great impact in public health. We introduce now the different developed vaccines and their state of progress.

Factores de riesgo asociados a sepsis neonatal / Risk factors associated to neonatal sepsis

Objetivos: identificar los factores de riesgo y el grado de asociación de los mismos con la sepsis neonatal precoz y tardía. Métodos: se realizó un estudio analítico observacional de casos y controles en el Servicio de Neonatología del Hospital de la Mujer, La Paz Bolivia, de 322 recién nacidos (historias clínicas), 108 casos y 214 controles. Resultados: se analizaron 322 historias clínicas y los factores que tuvieron significancia como riesgo para sepsis neonatal precoz fueron: edad gestacional pretérmino (OR 5.47, IC 95% 2.14-14.83), el bajo peso al nacer (OR 3.09, IC 95% 1.55-6.16), la ruptura prematura de membranas (OR 3.87, IC 95% 2.06-7.32), la infección de vías urinarias (OR 3.21, IC 95% 1.49-6.89) y la corioamnionitis (OR 4.69, IC 95% 1.0521.63). La hipertensión arterial (OR 114.44, IC 95% 37.90-366), la utilización de vía central (OR 5.41, IC 95% 2.57-11.4) y ventilación mecánica (OR 3.26, IC 95% 1.6-6.66) como procedimientos invasivos fueron factores de riesgo significantes para sepsis neo natal tardía. Los factores de riesgo para el fallecimiento de los niños fueron: ser recién nacido pretermino (OR 3.3, IC 95% 1.6-6.87), tener bajo peso al nacer (OR 13.07, IC 95% 6.84-25.13), que la madre haya presentado infección de vías urinarias (OR 2.08, IC 95% 1.03-4.15) y la utilización de vía central (OR 8.46, IC 95% 4.43-16.26) y ventilación mecánica (OR 17.94 IC 95% 9.17-35.45) en los neonatos. Conclusiones: los hallazgos del presente estudio demuestran que la sepsis es una causa de mortalidad neonatal y que la presencia de esta patología ya sea de tipo precoz o tardía, esta determinada por varios factores, los cuales, al estar presentes en la madre o el niño se convierten en factores de riesgo que puedes ser tratados o prevenidos una vez que son diagnosticados.

Objectives: Identifying risk factors and to what degree are these associated to early and delayed neo natal sepsis. Method: An analytical study was carried out observing cases and their follow-up at the Neonatology Department of the Women's Hospital in La Paz, Bolivia. The study included 322 newborn clinical histories, 108 cases and 214 follow-ups. Results: 322 clinical histories were revised. Risk factors that were significant for neo natal sepsis, either early of delayed were: premature birth (OR 5.47, IC 95% 2.14-14.83), low birth weight (OR 3.09, IC 95% 1.55-6.16), premature membrane rupture (OR3.87, IC 95% 2.06-7.32), urinary tract infection (OR 3.21, IC 95% 1.49-6.89) and "chorioarnnionitis" (OR 4.69, IC 95% 1.05,-21.63). Significant risk factors for delayed neonatal sepsis were invasive procedures such as high blood pressure (OR 114.44, IC 95% 37.90-366), use of main pathway (OR 5.41, IC 95% 2.57-11.4) and mechanical ventilation (OR 3.26, IC 95% 1.6-6.66). Risk factors for newborn deaths were: premature births, (OR 3.3, IC 95% 1.6-6.87), low birth weight (OR 13.07, IC 95% 6.84-25.13), urinary tract infection in the mother (OR 2.08, IC 95% 1.03-4.15) use of main pathway (OR 8.46, IC 95% 4.43-16.26) and mechanical ventilation (OR 17.94, IC 95% 9.17-35.45) Conclusions: findings in this study show that sepsis causes neonatal death be it early or delayed and that it is caused by several factors which may originate either in the mother or the baby which turn into risk factors that may be treated or prevented once they are diagnosed.