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- W2022677792 abstract "Since 1992, professional societies or public health agencies in the US1Committee on Infectious DiseasesCommittee on Fetus and NewbornGuidelines for prevention of group B streptococcal (GBS) infection by chemoprophylaxis.Pediatrics. 1992; 90: 775-778PubMed Google Scholar, 2Committee on Technical BulletinsGroup B streptococcal infections in pregnancy. ACOG Technical Bulletin Number 170.Int J Gynaecol Obstet. 1993; 42: 55-59Abstract Full Text PDF PubMed Scopus (30) Google Scholar, 3Centers for Disease Control and PreventionPrevention of perinatal group B streptococcal disease: a public health perspective.MMWR Recomm Rep. 1996; 45: 1-24Google Scholar, 4Committee on Obstetric PracticePrevention of early-onset group B streptococcal disease in newborns. ACOG Committee Opinion Number 173.Int J Gynaecol Obstet. 1996; 54: 197-205Abstract Full Text PDF PubMed Scopus (54) Google Scholar, 5Committee on Infectious DiseasesCommittee on Fetus and NewbornRevised guidelines for prevention of early-onset group B streptococcal (GBS) infection.Pediatrics. 1997; 99: 489-496Crossref PubMed Scopus (328) Google Scholar, 6Schrag S. Gorwitz R. Fultz-Butts K. Schuchat A. Prevention of perinatal group B streptococcal disease. Revised guidelines from CDC.MMWR Recomm Rep. 2002; 51: 1-22PubMed Google Scholar, 7Committee on Obstetric PracticePrevention of early-onset group B streptococcal disease in newborns. ACOG Committee Opinion Number 279.Obstet Gynecol. 2002; 100: 1405-1412Crossref PubMed Scopus (141) Google Scholar, 8Verani J.R. McGee L. Schrag S.J. Prevention of Perinatal Group B Streptococcal Disease—Revised Guidelines from CDC, 2010.MMWR Recomm Rep. 2010; 59: 1-36PubMed Google Scholar, 9American Academy of PediatricsStatement of Endorsement—perinatal group B streptococcal disease.Pediatrics. 2010; 127: 396Google Scholar, 10Committee on Obstetric PracticePrevention of early-onset group B streptococcal disease in newborns. ACOG Committee Opinion Number 485.Obstet Gynecol. 2011; 117: 1019-1027Crossref PubMed Scopus (116) Google Scholar, 11Committee on Infectious DiseasesCommittee on Fetus and NewbornRecommendations for the prevention of perinatal group B streptococcal (GBS) disease.Pediatrics. 2011; 128: 611-616Crossref PubMed Scopus (22) Google Scholar, 12Polin R.A. Papile L. Baley J. Benitz W. Carlo W. Cummings J. et al.Management of neonates with suspected or proven early-onset bacterial sepsis.Pediatrics. 2012; 129: 1006-1015Crossref PubMed Scopus (501) Google Scholar and elsewhere13Infectious Diseases and Immunization CommitteeThe prevention of early-onset group B streptococcal infections in the newborn.Can J Infect Dis. 1994; 5: 251-256PubMed Google Scholar, 14Money D. Allen V.M. Society of Obstetricians and Gynaecologists of CanadaThe prevention of early-onset neonatal group B streptococcal disease.J Obstet Gynaecol Can. 2013; 35: 939-951Abstract Full Text Full Text PDF PubMed Scopus (56) Google Scholar, 15Demianczuk N.N. Halperin S.A. McMillan D.D. Prevention of perinatal group B streptococcal infection: management strategies.Can J Infect Dis. 1997; 8: 68-70PubMed Google Scholar, 16National Collaborating Centre for Women’s and Children’s HealthAntibiotics for early-onset neonatal infection: Antibiotics for the prevention and treatment of early-onset neonatal infection (CG149). National Institute for Health and Clinical Excellence, London2012Google Scholar, 17Rodriguez-Granger J. Alvargonzalez J.C. Berardi A. Berner R. Kunze M. Hufnagel M. et al.Prevention of group B streptococcal neonatal disease revisited. The DEVANI European project.Eur J Clin Microbiol Infect Dis. 2012; 31: 2097-2104Crossref PubMed Scopus (58) Google Scholar have issued several generations of recommendations for prevention or management of early-onset neonatal sepsis (EOS). Despite those efforts, recommendations remain inconsistent, clarifications are necessary,18Brady M.T. Polin R.A. Prevention and management of infants with suspected or proven neonatal sepsis.Pediatrics. 2013; 132: 166-168Crossref PubMed Scopus (53) Google Scholar local adaptations are common,19Mukhopadhyay S. Dukhovny D. Mao W. Eichenwald E.C. Puopolo K.M. 2010 perinatal GBS prevention guideline and resource utilization.Pediatrics. 2014; 133: 196-203Crossref PubMed Scopus (46) Google Scholar and compliance rates are low.20Malloy M.H. Chorioamnionitis: epidemiology of newborn management and outcome United States 2008.J Perinatol. 2014; 34: 611-615Crossref PubMed Scopus (41) Google Scholar We postulate that lack of consensus, especially regarding postnatal management of the neonate, is largely a result of 2 sets of factors. First, obstetrical prevention strategies have reduced substantially the incidence of EOS, potentially changing the utility of predictive strategies based on risk factors. Second, recent data better delineate relationships among risk factors, clinical signs, and EOS, suggesting that risk predictors may have different utilities in different groups. The purpose of this commentary is to explore these questions and to suggest new approaches to management of newborns who may be at risk for EOS.The Evolution of Neonatal Sepsis Risk AssessmentAdoption of intrapartum antibiotic prophylaxis for the prevention of early-onset group B streptococcal (GBS) sepsis since 1995 has resulted in an 85% reduction in the rate of culture-proven early-onset GBS sepsis, from approximately 1.8 per 1000 live births in the early 1990s21Schrag S.J. Zywicki S. Farley M.M. Reingold A.L. Harrison L.H. Lefkowitz L.B. et al.Group B streptococcal disease in the era of intrapartum antibiotic prophylaxis.N Engl J Med. 2000; 342: 15-20Crossref PubMed Scopus (828) Google Scholar to fewer than 0.25 per 1000 live births22Centers for Disease Control and PreventionActive Bacterial Core Surveillance (ABCs) Report: Group B streptococcus, 2012. Centers for Disease Control and Prevention, 2013http://www.cdc.gov/abcs/reports-findings/survreports/gbs12.pdfGoogle Scholar since 2010. Comparable data for EOS of all causes also reflect a reduction in attack rate, from 2.0 to 2.5 in the late 1980s and 1990s23Cordero L. Rau R. Taylor D. Ayers L.W. Enteric gram-negative bacilli bloodstream infections: 17 years' experience in a neonatal intensive care unit.Am J Infect Control. 2004; 32: 189-195Abstract Full Text Full Text PDF PubMed Scopus (104) Google Scholar, 24Sanghvi K.P. Tudehope D.I. Neonatal bacterial sepsis in a neonatal intensive care unit: a 5 year analysis.J Paediatr Child Health. 1996; 32: 333-338Crossref PubMed Scopus (66) Google Scholar, 25Isaacs D. Barfield C.P. Grimwood K. McPhee A.J. Minutillo C. Tudehope D.I. et al.Systemic bacterial and fungal infections in infants in Australian neonatal units.Med J Aust. 1995; 162: 198-201PubMed Google Scholar to 0.8 to 1.0 per 1000 live births since 2005.26Stoll B.J. Hansen N.I. Sanchez P.J. Faix R.G. Poindexter B.B. Van Meurs K.P. et al.Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues.Pediatrics. 2011; 127: 817-826Crossref PubMed Scopus (735) Google Scholar, 27Weston E.J. Pondo T. Lewis M.M. Martell-Cleary P. Morin C. Jewell B. et al.The burden of invasive early-onset neonatal sepsis in the United States, 2005-2008.Pediatr Infect Dis J. 2011; 30: 937-941Crossref PubMed Scopus (324) Google Scholar Among infants ≥3428Escobar G.J. Puopolo K.M. Wi S. Turk B.J. Kuzniewicz M.W. Walsh E.M. et al.Stratification of risk of early-onset sepsis in newborns >/= 34 weeks' gestation.Pediatrics. 2014; 133: 30-36Crossref PubMed Scopus (216) Google Scholar or ≥3529Jackson G.L. Rawiki P. Sendelbach D. Manning M.D. Engle W.D. Hospital course and short-term outcomes of term and late preterm neonates following exposure to prolonged rupture of membranes and/or chorioamnionitis.Pediatr Infect Dis J. 2012; 31: 89-90Crossref PubMed Scopus (23) Google Scholar, 30Kiser C. Nawab U. McKenna K. Aghai Z.H. Role of guidelines on length of therapy in chorioamnionitis and neonatal sepsis.Pediatrics. 2014; 133: 992-998Crossref PubMed Scopus (80) Google Scholar weeks' gestation or with birth weights >2500 g,26Stoll B.J. Hansen N.I. Sanchez P.J. Faix R.G. Poindexter B.B. Van Meurs K.P. et al.Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues.Pediatrics. 2011; 127: 817-826Crossref PubMed Scopus (735) Google Scholar recent EOS rates are only 0.5-0.8 per 1000 live births. These much lower attack rates reflect a landscape that is fundamentally different from that extant when consensus guidelines for neonatal sepsis management were being developed 20 years ago. These changes prompt the question of whether predictive tools that had utility in the past might be less valuable now. If so, the development of novel approaches better suited to current circumstances may be necessary.Current guidelines from the Centers for Disease Control and Prevention (CDC) recommend diagnostic evaluation, including blood and cerebrospinal fluid cultures, and treatment with broad-spectrum antibiotics for infants who show clinical signs of sepsis.8Verani J.R. McGee L. Schrag S.J. Prevention of Perinatal Group B Streptococcal Disease—Revised Guidelines from CDC, 2010.MMWR Recomm Rep. 2010; 59: 1-36PubMed Google Scholar Current American Academy of Pediatrics (AAP) guidelines advocate the same approach for critically ill infants but are less prescriptive with respect to infants with relatively mild findings.12Polin R.A. Papile L. Baley J. Benitz W. Carlo W. Cummings J. et al.Management of neonates with suspected or proven early-onset bacterial sepsis.Pediatrics. 2012; 129: 1006-1015Crossref PubMed Scopus (501) Google Scholar The nature and severity of clinical findings that constitute a threshold for treatment remain problematic. Many infants with mild illness become asymptomatic over the first 6 hours and can be observed safely without treatment, unless signs worsen or fail to improve. Although 80%-100% of infants with blood cultures positive for a pathogenic organism exhibit clinical signs consistent with sepsis in the first 48 hours after birth,26Stoll B.J. Hansen N.I. Sanchez P.J. Faix R.G. Poindexter B.B. Van Meurs K.P. et al.Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues.Pediatrics. 2011; 127: 817-826Crossref PubMed Scopus (735) Google Scholar, 31Bromberger P. Lawrence J.M. Braun D. Saunders B. Contreras R. Petitti D.B. The influence of intrapartum antibiotics on the clinical spectrum of early-onset group B streptococcal infection in term infants.Pediatrics. 2000; 106: 244-250Crossref PubMed Scopus (111) Google Scholar, 32Ottolini M.C. Lundgren K. Mirkinson L.J. Cason S. Ottolini M.G. Utility of complete blood count and blood culture screening to diagnose neonatal sepsis in the asymptomatic at risk newborn.Pediatr Infect Dis J. 2003; 22: 430-434PubMed Google Scholar, 33Hashavya S. Benenson S. Ergaz-Shaltiel Z. Bar-Oz B. Averbuch D. Eventov-Friedman S. The use of blood counts and blood cultures to screen neonates born to partially treated group B Streptococcus-carrier mothers for early-onset sepsis: is it justified?.Pediatr Infect Dis J. 2011; 30: 840-843Crossref PubMed Scopus (20) Google Scholar, 34Flidel-Rimon O. Galstyan S. Juster-Reicher A. Rozin I. Shinwell E.S. Limitations of the risk factor based approach in early neonatal sepsis evaluations.Acta Paediatr. 2012; 101: e540-e544Crossref PubMed Scopus (27) Google Scholar those signs are nonspecific.Rates of EOS among newborn infants with such clinical signs are low, ranging from 2.7% to 5.6%,32Ottolini M.C. Lundgren K. Mirkinson L.J. Cason S. Ottolini M.G. Utility of complete blood count and blood culture screening to diagnose neonatal sepsis in the asymptomatic at risk newborn.Pediatr Infect Dis J. 2003; 22: 430-434PubMed Google Scholar, 34Flidel-Rimon O. Galstyan S. Juster-Reicher A. Rozin I. Shinwell E.S. Limitations of the risk factor based approach in early neonatal sepsis evaluations.Acta Paediatr. 2012; 101: e540-e544Crossref PubMed Scopus (27) Google Scholar, 35Cantoni L. Ronfani L. Da Riol R. Demarini S. Perinatal Study Group of the Region Friuli-Venezia GiuliaPhysical examination instead of laboratory tests for most infants born to mothers colonized with group B Streptococcus: support for the Centers for Disease Control and Prevention’s 2010 recommendations.J Pediatr. 2013; 163: 568-573Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar corresponding to numbers needed to treat (NNTs) to potentially benefit the one child with bacterial infection between 18 and 38. Thus, clinical signs of illness are reliable but inefficient for the identification of infants with EOS. Reduction of unnecessary treatment in this subpopulation will require development of a rapid, sensitive diagnostic test (likely based on early components of the innate immune response) with a strong negative predictive value for EOS. Until such a test is available, infants with significant clinical signs of possible EOS should continue to have diagnostic cultures and should be treated with antibiotics. Currently available laboratory tests (such as blood cell counts, C-reactive protein, and procalcitonin levels) are not sufficiently sensitive or specific to justify their use to decide whether to initiate or withhold empiric treatment of infants with clinical signs of illness. The use of these laboratory tests should be limited to reliance on the utility of serial normal results for identification of infants without sepsis36Benitz W.E. Han M.Y. Madan A. Ramachandra P. Serial serum C-reactive protein levels in the diagnosis of neonatal infection.Pediatrics. 1998; 102: E41Crossref PubMed Scopus (322) Google Scholar, 37Mikhael M. Brown L.S. Rosenfeld C.R. Serial neutrophil values facilitate predicting the absence of neonatal early-onset sepsis.J Pediatr. 2014; 164: 522-528Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar, 38Murphy K. Weiner J. Use of leukocyte counts in evaluation of early-onset neonatal sepsis.Pediatr Infect Dis J. 2012; 31: 16-19Crossref PubMed Scopus (53) Google Scholar, 39Pourcyrous M. Bada H.S. Korones S.B. Baselski V. Wong S.P. Significance of serial C-reactive protein responses in neonatal infection and other disorders.Pediatrics. 1993; 92: 431-435PubMed Google Scholar to support early discontinuation of empiric treatment.Maternal chorioamnionitis is the second risk criterion in both the CDC8Verani J.R. McGee L. Schrag S.J. Prevention of Perinatal Group B Streptococcal Disease—Revised Guidelines from CDC, 2010.MMWR Recomm Rep. 2010; 59: 1-36PubMed Google Scholar and AAP12Polin R.A. Papile L. Baley J. Benitz W. Carlo W. Cummings J. et al.Management of neonates with suspected or proven early-onset bacterial sepsis.Pediatrics. 2012; 129: 1006-1015Crossref PubMed Scopus (501) Google Scholar guidelines. Both recommend treatment with broad-spectrum antibiotics when this diagnosis is made and acknowledge challenges in the use of this obstetrical diagnosis to guide neonatal therapy. Early studies that linked EOS to chorioamnionitis used strict diagnostic criteria, requiring 1 or 2 clinical findings in addition to maternal fever.40Gibbs R.S. Castillo M.S. Rodgers P.J. Management of acute chorioamnionitis.Am J Obstet Gynecol. 1980; 136: 709-713Abstract Full Text PDF PubMed Scopus (181) Google Scholar It has proven difficult to incorporate strict criteria into routine clinical practice, and the diagnosis now often is based on observation of maternal fever alone.20Malloy M.H. Chorioamnionitis: epidemiology of newborn management and outcome United States 2008.J Perinatol. 2014; 34: 611-615Crossref PubMed Scopus (41) Google Scholar Lack of precision in diagnosing chorioamnionitis seriously compromises its reliability as a predictive measure.The recommendation to treat infants exposed to chorioamnionitis was largely based on the belief that chorioamnionitis was a factor in nearly 90% of the instances in which intrapartum antibiotics had failed to prevent EOS.41Benitz W.E. Gould J.B. Druzin M.L. Risk factors for early-onset group B streptococcal sepsis: estimation of odds ratios by critical literature review.Pediatrics. 1999; 103: e77Crossref PubMed Scopus (212) Google Scholar More recent data suggest that fewer instances of “failed” intrapartum prophylaxis are associated with chorioamnionitis (<50%42Velaphi S. Siegel J.D. Wendel Jr., G.D. Cushion N. Eid W.M. Sanchez P.J. Early-onset group B streptococcal infection after a combined maternal and neonatal group B streptococcal chemoprophylaxis strategy.Pediatrics. 2003; 111: 541-547Crossref PubMed Scopus (54) Google Scholar). Only one study published before the year 2000 provided data for calculation of an overall (all birth weights) OR for EOS associated with chorioamnionitis (aOR 4.4, 95% CI 1.2-16.1).43Yancey M.K. Duff P. Kubilis P. Clark P. Frentzen B.H. Risk factors for neonatal sepsis.Obstet Gynecol. 1996; 87: 188-194Crossref PubMed Scopus (106) Google Scholar More recent reports indicate that the risk of EOS in infants born to women with chorioamnionitis is strongly dependent on gestational age. In 3 reports including 1892 infants born at ≥35 weeks' gestation to mothers with clinical chorioamnionitis, the rates of EOS (positive blood culture at ≤72 hours of age) were only 0.47%,44Jackson G.L. Engle W.D. Sendelbach D.M. Vedro D.A. Josey S. Vinson J. et al.Are complete blood cell counts useful in the evaluation of asymptomatic neonates exposed to suspected chorioamnionitis?.Pediatrics. 2004; 113: 1173-1180Crossref PubMed Scopus (49) Google Scholar 1.24%,29Jackson G.L. Rawiki P. Sendelbach D. Manning M.D. Engle W.D. Hospital course and short-term outcomes of term and late preterm neonates following exposure to prolonged rupture of membranes and/or chorioamnionitis.Pediatr Infect Dis J. 2012; 31: 89-90Crossref PubMed Scopus (23) Google Scholar and 0.72%30Kiser C. Nawab U. McKenna K. Aghai Z.H. Role of guidelines on length of therapy in chorioamnionitis and neonatal sepsis.Pediatrics. 2014; 133: 992-998Crossref PubMed Scopus (80) Google Scholar (NNT to prevent one infection 80-210). In contrast, 4.8%-16.9%45Soraisham A.S. Singhal N. McMillan D.D. Sauve R.S. Lee S.K. Canadian Neonatal N. A multicenter study on the clinical outcome of chorioamnionitis in preterm infants.Am J Obstet Gynecol. 2009; 200: 372.e1-372.e6Abstract Full Text Full Text PDF Scopus (160) Google Scholar, 46Pappas A. Kendrick D.E. Shankaran S. Stoll B.J. Bell E.F. Laptook A.R. et al.Chorioamnionitis and early childhood outcomes among extremely low-gestational-age neonates.JAMA Pediatr. 2014; 168: 137-147Crossref PubMed Scopus (147) Google Scholar, 47Gagliardi L. Rusconi F. Bellu R. Zanini R. Italian Neonatal NetworkAssociation of maternal hypertension and chorioamnionitis with preterm outcomes.Pediatrics. 2014; 134: e154-e161Crossref PubMed Scopus (44) Google Scholar, 48Garcia-Munoz Rodrigo F. Galan Henriquez G. Figueras Aloy J. Garcia-Alix Perez A. Outcomes of very-low-birth-weight infants exposed to maternal clinical chorioamnionitis: a multicentre study.Neonatology. 2014; 106: 229-234Crossref PubMed Scopus (11) Google Scholar, 49Garcia-Munoz Rodrigo F. Galan Henriquez G.M. Ospina C.G. Morbidity and mortality among very-low-birth-weight infants born to mothers with clinical chorioamnionitis.Pediatr Neonatol. 2014; 55: 381-386Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar of preterm infants exposed to chorioamnionitis develop EOS (NNT 6-21). None of these studies stratified risk according to presence or absence of clinical signs of illness, so the proportion of affected infants who would have been treated on that basis cannot be estimated. Among preterm infants, that proportion is likely to have been substantial, so the utility of chorioamnionitis as a screening tool in that population is uncertain. Nonetheless, treatment for chorioamnionitis-exposed preterm infants, based on the high attack rates and low NNT in that group, remains justified.Among asymptomatic late-preterm and term infants with risk factors as defined by the CDC8Verani J.R. McGee L. Schrag S.J. Prevention of Perinatal Group B Streptococcal Disease—Revised Guidelines from CDC, 2010.MMWR Recomm Rep. 2010; 59: 1-36PubMed Google Scholar (including but not limited to clinical chorioamnionitis), the risk of EOS is extremely low. Hashavya et al33Hashavya S. Benenson S. Ergaz-Shaltiel Z. Bar-Oz B. Averbuch D. Eventov-Friedman S. The use of blood counts and blood cultures to screen neonates born to partially treated group B Streptococcus-carrier mothers for early-onset sepsis: is it justified?.Pediatr Infect Dis J. 2011; 30: 840-843Crossref PubMed Scopus (20) Google Scholar found no cases of early-onset GBS sepsis among 1413 clinically well infants. Flidel-Rimon et al34Flidel-Rimon O. Galstyan S. Juster-Reicher A. Rozin I. Shinwell E.S. Limitations of the risk factor based approach in early neonatal sepsis evaluations.Acta Paediatr. 2012; 101: e540-e544Crossref PubMed Scopus (27) Google Scholar reported a single instance of a positive blood culture (in a preterm infant) among 1662 at-risk infants. Ottolini et al32Ottolini M.C. Lundgren K. Mirkinson L.J. Cason S. Ottolini M.G. Utility of complete blood count and blood culture screening to diagnose neonatal sepsis in the asymptomatic at risk newborn.Pediatr Infect Dis J. 2003; 22: 430-434PubMed Google Scholar and Buckler et al50Buckler B. Bell J. Sams R. Cagle W. Bell S.A. Allen C. et al.Unnecessary workup of asymptomatic neonates in the era of group B streptococcus prophylaxis.Infect Dis Obstet Gynecol. 2010; 2010: 1-3Crossref Scopus (23) Google Scholar reported no EOS cases among 1665 and 242 at-risk infants ≥35 weeks' or >37 weeks' gestation, respectively. Predictive utility is not enhanced by use of the more objective diagnosis of histopathologic chorioamnionitis (HCA). Cuna et al51Cuna A. Hakima L. Tseng Y.A. Fornier B. Islam S. Quintos-Alagheband M.L. et al.Clinical dilemma of positive histologic chorioamnionitis in term newborn.Front Pediatr. 2014; 2: 1-5Crossref Scopus (20) Google Scholar observed no cases of clinical or culture-proven sepsis among 284 newborn infants who had HCA but neither risk factors for nor clinical signs of infection. Among infants admitted to the neonatal intensive care unit because of risk factors or clinical signs, there was no difference in the prevalence of EOS between those with (1 of 105) or without HCA (2 of 283). The authors concluded that histopathologic examination of the placenta adds little to conventional testing in guiding decisions about discontinuation of treatment. These data make it apparent that it is time to abandon the policy of treating well-appearing infants ≥34 weeks' gestation because of chorioamnionitis alone.Investigators in Boston and Northern California have taken the lead in implementing a change in practice. Recognizing the potential inconsistency in making the diagnosis of chorioamnionitis, they have chosen to rely upon maternal fever alone as a surrogate for the risk associated with chorioamnionitis.19Mukhopadhyay S. Dukhovny D. Mao W. Eichenwald E.C. Puopolo K.M. 2010 perinatal GBS prevention guideline and resource utilization.Pediatrics. 2014; 133: 196-203Crossref PubMed Scopus (46) Google Scholar Using data from more than 600 000 infants ≥34 weeks' gestation at birth, they developed a model for EOS risk prediction based on maternal factors (gestational age, GBS colonization, duration of ruptured membranes, greatest intrapartum temperature, and nature and duration of intrapartum antibiotics),52Puopolo K.M. Draper D. Wi S. Newman T.B. Zupancic J. Lieberman E. et al.Estimating the probability of neonatal early-onset infection on the basis of maternal risk factors.Pediatrics. 2011; 128: e1155-e1163Crossref PubMed Scopus (222) Google Scholar and then combined that model with findings from examination of the infants28Escobar G.J. Puopolo K.M. Wi S. Turk B.J. Kuzniewicz M.W. Walsh E.M. et al.Stratification of risk of early-onset sepsis in newborns >/= 34 weeks' gestation.Pediatrics. 2014; 133: 30-36Crossref PubMed Scopus (216) Google Scholar to stratify subgroups according to EOS attack rates (Table I).53Escobar G.J. Puopolo K.M. Wi S. Turk B.J. Kuzniewicz M.W. Walsh E.M. et al.Erratum to: Stratification of risk of early-onset sepsis in newborns >/= 34 weeks' gestation.Pediatrics. 2014; 134: 193Google Scholar Sequential selection of subgroups for empiric treatment, in order of increasing NNT (Table II), demonstrates a trade-off between the proportion of cases included in the treatment group and the overall NNT, implying that the practitioner must either treat a very large proportion of the population (large NNT) or fail to achieve early treatment of a large fraction of the cases (high false-negative rate). In the latter case, close clinical monitoring will be necessary to identify untreated infants who develop clinical signs of sepsis. The observation that even such optimal utilization of information about maternal risk factors fails to yield an efficient and highly effective ascertainment strategy28Escobar G.J. Puopolo K.M. Wi S. Turk B.J. Kuzniewicz M.W. Walsh E.M. et al.Stratification of risk of early-onset sepsis in newborns >/= 34 weeks' gestation.Pediatrics. 2014; 133: 30-36Crossref PubMed Scopus (216) Google Scholar should prompt consideration of alternative approaches.Table IRisk stratification based on maternal risk factors and newborn examination28Escobar G.J. Puopolo K.M. Wi S. Turk B.J. Kuzniewicz M.W. Walsh E.M. et al.Stratification of risk of early-onset sepsis in newborns >/= 34 weeks' gestation.Pediatrics. 2014; 133: 30-36Crossref PubMed Scopus (216) Google ScholarSepsis risk at birth (cases per 1000 births)∗Data for infants with previous probabilities of 0.65-1.54 or ≥1.54 are pooled for those with equivocal findings or clinical illness, due to small sample sizes in the corresponding cells. Values calculated from data of Escobar et al28 in Supplemental Figure 8 and published erratum.53All<0.650.65-1.54≥1.54Proportion of cases, % Well-appearing15.68.87.732.0 Equivocal findings14.410.925.3 Clinical illness24.518.242.7 Total54.545.5100.0Proportion of cohort, % Well-appearing84.74.70.790.1 Equivocal findings6.40.67.0 Clinical illness2.60.42.9 Total93.76.3100.0Attack rates (per 1000 births) Well-appearing0.111.086.740.21 Equivocal findings1.3111.072.11 Clinical illness5.5727.108.43 Total0.344.180.58NNT Well-appearing93709231484845 Equivocal findings76390474 Clinical illness18037119 Total29612391722∗ Data for infants with previous probabilities of 0.65-1.54 or ≥1.54 are pooled for those with equivocal findings or clinical illness, due to small sample sizes in the corresponding cells. Values calculated from data of Escobar et al28Escobar G.J. Puopolo K.M. Wi S. Turk B.J. Kuzniewicz M.W. Walsh E.M. et al.Stratification of risk of early-onset sepsis in newborns >/= 34 weeks' gestation.Pediatrics. 2014; 133: 30-36Crossref PubMed Scopus (216) Google Scholar in Supplemental Figure 8 and published erratum.53Escobar G.J. Puopolo K.M. Wi S. Turk B.J. Kuzniewicz M.W. Walsh E.M. et al.Erratum to: Stratification of risk of early-onset sepsis in newborns >/= 34 weeks' gestation.Pediatrics. 2014; 134: 193Google Scholar Open table in a new tab Table IICase capture and NNT for sequential inclusion of groups based on risk stratification model28Escobar G.J. Puopolo K.M. Wi S. Turk B.J. Kuzniewicz M.W. Walsh E.M. et al.Stratification of risk of early-onset sepsis in newborns >/= 34 weeks' gestation.Pediatrics. 2014; 133: 30-36Crossref PubMed Scopus (216) Google ScholarGroup (exam findings and prior probability)Cumulative % of casesCumulative % of populationCumulative NNTIll ≥0.65180.437+ Equivocal ≥0.65291.057+ Well ≥1.54371.676+ Ill <0.65614.2117+ Equivocal <0.657610.6241+ Well 0.65-1.548415.3312+ Well <0.65100100.01722 Open table in a new tab Reports of reliance on serial examination rather than risk factors or screening laboratory tests are emerging from the US,32Ottolini M.C. Lundgren K. Mirkinson L.J. Cason S. Ottolini M.G. Utility of complete blood count and blood culture screening to diagnose neonatal sepsis in the asymptomatic at risk newborn.Pediatr Infect Dis J. 2003; 22: 430-434PubMed Google Scholar Israel,33Hashavya S. Benenson S. Ergaz-Shaltiel Z. Bar-Oz B. Averbuch D. Eventov-Friedman S. The use of blood counts and blood cultures to screen neonates born to partially treated group B Streptococcus-carrier mothers for early-onset sepsis: is it justified?.Pediatr Infect Dis J. 2011; 30: 840-843Crossref PubMed Scopus (20) Google Scholar, 34Flidel-Rimon O. Galstyan S. Juster-Reicher A. Rozin I. Shinwell E.S. Limitations of the risk factor based approach in early neonatal sepsis evaluations.Acta Paediatr. 2012; 101: e540-e544Crossref PubMed Scopus (27) Google Scholar and Italy35Cantoni L. Ronfani L. Da Riol R. Demarini S. Perinatal Study Group of the Region Friuli-Venezia GiuliaPhysical examination instead of laboratory tests for most infants born to mothers colonized with group B Streptococcus: support for the Centers for Disease Control and Prevention’s 2010 recommendations.J Pediatr. 2013; 163: 568-573Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar, 54Berardi A. Fornaciari S. Rossi C. Patianna V. Bacchi Reggiani M.L. Ferrari F. et al.Safety of physical examination alone for managing well-appearing neonates >/=35 weeks' gestation at risk for early-onset sepsis.J Matern Fetal Neonatal Med. 2014; (In press)Google Scholar (Table III), showing that: (1) the risk of EOS is very small in well-appearing, late-preterm and term infants (the sole asymptomatic infant with sepsis in these reports was a preterm infant exposed to chorioamnionitis34Flidel-Rimon O. Galstyan S. Juster-Reiche" @default.
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- W2022677792 date "2015-04-01" @default.
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- W2022677792 title "Reappraisal of Guidelines for Management of Neonates with Suspected Early-Onset Sepsis" @default.
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