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BACKGROUND: The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, evidence that its use improves clinical outcomes is lacking. METHODS: In this randomized, phase 3 trial conducted at 70 sites in 17 countries, we assigned extremely preterm infants (gestational age, <28 weeks), within 6 hours after birth, to receive treatment guided by cerebral oximetry monitoring for the first 72 hours after birth or to receive usual care. The primary outcome was a composite of death or severe brain injury on cerebral ultrasonography at 36 weeks' postmenstrual age. Serious adverse events that were assessed were death, severe brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and late-onset sepsis. RESULTS: A total of 1601 infants underwent randomization and 1579 (98.6%) were evaluated for the primary outcome. At 36 weeks' postmenstrual age, death or severe brain injury had occurred in 272 of 772 infants (35.2%) in the cerebral oximetry group, as compared with 274 of 807 infants (34.0%) in the usual-care group (relative risk with cerebral oximetry, 1.03; 95% confidence interval, 0.90 to 1.18; P = 0.64). The incidence of serious adverse events did not differ between the two groups. CONCLUSIONS: In extremely preterm infants, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury at 36 weeks' postmenstrual age than usual care. (Funded by the Elsass Foundation and others; SafeBoosC-III ClinicalTrials.gov number, NCT03770741.).
Assuntos
Lactente Extremamente Prematuro , Doenças do Prematuro , Oximetria , Humanos , Lactente , Recém-Nascido , Lesões Encefálicas/diagnóstico por imagem , Lesões Encefálicas/etiologia , Displasia Broncopulmonar/etiologia , Circulação Cerebrovascular , Doenças do Prematuro/diagnóstico , Doenças do Prematuro/mortalidade , Doenças do Prematuro/terapia , Oximetria/métodos , Cérebro , Ultrassonografia , Retinopatia da Prematuridade/etiologia , Enterocolite Necrosante/etiologia , Sepse Neonatal/etiologiaRESUMO
OBJECTIVE: This study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO2). DESIGN: Multicentre randomised cross-over study. SETTING: Five neonatal intensive care units experienced with automated control of FiO2 and the fabian ventilator. PATIENTS: 39 infants: median gestational age of 27 weeks (IQR: 26-30), postnatal age 7 days (IQR: 2-17), weight 1120 g (IQR: 915-1588), FiO2 0.32 (IQR: 0.22-0.43) receiving both non-invasive (27) and invasive (12) respiratory support. INTERVENTION: Randomised sequential 24-hour periods of automated and manual FiO2 control. MAIN OUTCOME MEASURES: Proportion (%) of time in normoxaemia (90%-95% with FiO2>0.21 and 90%-100% when FiO2=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (<80%) and severe hyperoxaemia (>98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2 extremes. RESULTS: During automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p<0.001) with less time above and below (<90% (9%±8% vs 12%±11%, p<0.001) and >95% with FiO2>0.21 (16%±19% vs 35%±24%) p<0.001). They spent less time in severe hyperoxaemia (1% (0%-3.5%) vs 5% (1%-10%), p<0.001) but exposure to severe hypoxaemia was low in both arms and not different. The differences in prolonged episodes of SpO2 were consistent with the times at extremes. CONCLUSIONS: This study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO2 in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.
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Estudos Cross-Over , Unidades de Terapia Intensiva Neonatal , Saturação de Oxigênio , Humanos , Recém-Nascido , Feminino , Masculino , Hipóxia , Hiperóxia/prevenção & controle , Oxigênio/sangue , Oxigênio/administração & dosagem , Oximetria/métodos , Oxigenoterapia/métodos , Oxigenoterapia/efeitos adversos , Oxigenoterapia/instrumentação , Respiração Artificial/efeitos adversos , Recém-Nascido PrematuroRESUMO
UNLABELLED: Pregnancy promotes ureaplasma vaginal colonization. This creates the possibility of vertical transmission of these organisms to the child. These microorganisms can cause complications during pregnancy and poor condition of newborn. OBJECTIVES: Objectives of this study were to analyze the vertical transmission of different species of ureaplasmas in term newborns without respiratory distress. MATERIALS AND METHODS: The study included 50 mothers and 50 of their newborn children. Swabs were obtained from swabs of the cervix in women and tracheal aspirates from neonates. The presence of ureaplasmas was confirmed by culture and PCR. Ureaplasmas species identification was performed using PCR. RESULTS: infection of ureaplasmas was found in 21 women (42%). Predominant species was U. parvum, which was found in 18 women. In 3 patients only the presence of U. urealyticum was confirmed. Ureaplasma infection in mother and her newborn baby was confirmed in 8 (17.4%) mother-child pairs, including 6 of these cases showing the presence of U. parvum and 2 U. urealyticum. The incidence of vertical transmission of ureaplasma infection was assessed at 33% for U. parvum and 67% for U. urealyticum, and the total for both species at 38%. It should be noted that in the group of 18 women infected with U.parvum, in 12 cases there was no transmission of infection to the child. However in 3 women infected with U. urealyticum 2 cases of transmission from mother to child were observed (67%). Although the group infected with U. urealyticum accounted for only 3 women, our preliminary observations may suggest that this species is probably more likely to be transferred from mother to child. CONCLUSIONS: Infection with U. urealyticum may be more frequently transferred from the genital tract of mother to child.
Assuntos
Transmissão Vertical de Doenças Infecciosas , Complicações Infecciosas na Gravidez/diagnóstico , Complicações Infecciosas na Gravidez/microbiologia , Infecções por Ureaplasma/diagnóstico , Infecções por Ureaplasma/transmissão , Ureaplasma urealyticum/isolamento & purificação , Adulto , Asfixia Neonatal/microbiologia , Contagem de Colônia Microbiana , Feminino , Humanos , Recém-Nascido , Polônia , Reação em Cadeia da Polimerase , Gravidez , Reto/microbiologia , Fatores de Risco , Sensibilidade e Especificidade , Infecções por Ureaplasma/microbiologia , Vagina/microbiologia , Adulto JovemRESUMO
BACKGROUND: There are only a few reports in the literature about translocation of coagulase-negative staphylococci (CoNS) as a primary cause of sepsis in neonates, although CoNS are among a short list of "translocating" bacteria when present in abundance. METHODS: 468 blood samples, 119 stool samples, and 8 catheter tips, from 311 neonates, were tested for presence of microorganisms. CoNS strains isolated from the blood and stool or from blood and catheter tip of the same newborn at approximately the same time were paired and typed with PFGE (Pulse-Field Gel Electrophoresis) method. The strains were then tested for the presence of adherence genes and biofilm formation. RESULTS: The strains with identical PFGE profiles in comparison to those with non-identical profiles differed in terms of the pattern of the virulence genes and showed a lack of the genes related to adherence, but more often presence of IS256, which is related to virulence. They also were phenotypically unable to adhere to intestinal Caco2 cells. CONCLUSIONS: A considerable proportion of CoNS strains isolated from bloodstream of VLBW/LWB neonates was identical to the strains isolated from faeces of the same neonates at the same time. These observations may offer indirect evidence indicating that at least some CoNS can translocate from the gastrointestinal tract of the premature neonates into the bloodstream and thus cause generalized infection.
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AIM: Probiotic bacteria administered directly after birth to preterm neonates may improve gastrointestinal function and may reduce the incidence of late-onset sepsis, which is a frequent complication in this group. PURPOSE: The main objective of this study was to evaluate whether a new probiotic bacterial mixture of Lactobacillus rhamnosus KL53A and Bifidobacterium breve PB04 given to preterm, low-birth-weight neonates would influence composition of their gut microbiota and sepsis rates. PATIENTS AND METHODS: This study was a multicenter, randomized, double-blind, placebo-controlled trial conducted in clinical centers of neonatal care in Poland. A probiotic or placebo preparation was given twice daily to 181 preterm low-birth-weight neonates who were eligible for enteral feeding between July 2012 and July 2013. The probiotic was given to 90 neonates, while placebo was given to 91 neonates. The gut microbiota was monitored by microbiological analysis of stool samples. Sepsis episodes were detected on the basis of clinical and laboratory findings and confirmed by blood cultures. RESULTS: Tested probiotic administration resulted in continuous increase of the Lactobacillus and Bifidobacterium counts in the gut microbiota. The applied tested strains successfully colonized the neonates gut since they were present in over 90% of stool samples, which was confirmed by molecular analysis. Regardless of the study group (probiotic or placebo), B. breve colonization correlated with lower staphylococcal sepsis incidence, which was irrespective of whether probiotics were given. No sepsis case caused by strains included in study probiotic was recorded. CONCLUSION: Appropriately selected and characterized probiotic bacteria may be safely given to preterm neonates to normalize their distorted gut microbiota and may contribute to lower staphylococcal sepsis rates.
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UNLABELLED: The aim of this study was the analysis of the clinical state of newborns infected with various species of ureaplasma. METHODS: 50 prematurely born patients with respiratory disturbances and confirmed presence of ureaplasma in the respiratory tract were analyzed. Endotracheal aspirates were collected for examination. Presence of ureaplasma was confirmed by culture and a commercial test (Biomerieux), the ureaplasma species were identified using PCR. RESULTS: In 40 examined newborns Ureaplasma parvum (U.p.) was found, in 10 Ureaplasma urealyticum (U.u.). Newborns infected with U.u. were subject to more frequent and longer therapeutic procedures supporting respiration (respirator, nCPAP), needed more frequent surfactant and antibiotic administration. In the mentioned group the mortality rate was 33%, while in newborns infected with U.p. it was 15%. CONCLUSIONS: Initial results suggest worse clinical status and higher mortality of prematurely born infected with Ureaplasma urealyticum.