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Kaiser Permanente Prevention and Screening of Neonatal Sepsis
Clinical
Practice Guideline OCTOBER 1999
Prevention and Screening of Neonatal Sepsis
ENDORSED BY: CHIEFS OF NEONATOLOGY PERINATOLOGY PEER GROUP CHIEFS OF PEDIATRICS CHIEFS OF OBSTETRICS/GYNECOLOGY CHIEFS OF INFECTIOUS DISEASE
Applicable Population * Pregnant women where delivery is imminent. * Infants £ 72 hours of age, ³ 2000 grams, and ³35 weeks gestation.
Goals * Increase appropriate intrapartum antibiotic chemoprophylaxis. * Increase focus on the neonatal clinical examination; decrease emphasis on screening tests. * Ensure appropriate duration of neonatal observation for perinatal infection.
RECOMMENDATIONS Intrapartum Therapy 1. Mothers should receive intrapartum therapy if they have any of the following risk factors: * Chorioamnionitis * Prematurity (gestation < 37 weeks) * Antepartum temperature ³ 38"C (100.4º F) * Rupture of membranes (ROM) ³ 18 hours * History of group B streptococcus (GBS) bacteriuria or rectovaginal carriage during current pregnancy * Prior offspring with GBS disease
2. Preprinted orders should be used to facilitate prompt initiation of maternal antibiotic treatment. 3. Suggested intrapartum antibiotics: (Other antibiotic regimens are available, acceptable and effective.) *If chorioammonitis present ® Ampicillin (2 g IV initially then 1 g q4h) and gentamicin (7 mg/kg-dose IV q24h based on predelivery weight minus 10kg)l *If antibiotic treatment given for other risk factors ® Penicillin G (5 mU IV initially then 2.5 mU q4h until delivery). Alternative: Ampicillin (2 g IV initially then I g q4h).If the mother is allergic to penicillin: cefazolin sodium (2 g IV initially then I g q8h until delivery). Alternative: clindamycin (900 mg IV q8h).
Neonatal Management
4. Laboratory evaluation * Asymptomatic infants with maternal risk factors may require laboratory evaluation in addition to observation. ** Intraparturn antibiotics given > 4 hours prior to delivery: observe for 24 hours. ** Intraparturn antibiotics given < 4 hours prior to delivery: make individualized decision. ** No intrapartum antibiotics: consider obtaining complete blood count (CBC) to establish absolute neutrophil count (ANC), and blood culture; observe for 24 hours.
* Symptomatic infants require laboratory workup. ** If critically ill* or moderately ill*, obtain CBC to establish ANC, and blood culture. ** Other evaluations may be useful in selected settings: chest roentgenogram, lumbar puncture, endotracheal tube aspirate culture, urine culture. ** Not recommended: surface cultures, latex agglutination tests.
5. Antibiotic therapy should be initiated in most cases where one or more of the following conditions exist: * Infant critically ill.* *Maternal temperature ³ 38.6ºC (101.5ºF) within 12 hours before delivery. * Infant moderately ill* and clinical signs persist for 4 hours or more. * Infant moderately ill, clinical signs intermittent, and ANC is < 10,000.
6. Suggested neonatal antibiotics: (Other antibiotic regimens are available, acceptable and effective.) *Ampicillin (100 mg/kg-dose IV ql2h) and gentamicin (4 mg/kg-dose IV q24h). * Alternative: Ampicillin (100 mg/kg-dose IV ql2h) and cefotaxime (50 mg/kg-dose IV ql2h). * See Neluborn Clinical Exam Categories, page 2. Recommendations continue, page 2. * See Newborn Clinical Exam Categories, page 2.
Duration of Neonatal Hospital Observation & Antibiotic Treatment
7. Critical observation period is the first 6 hours after birth; observation period for assessing presence of infection in asymptomatic infants is 24 hours.
8. Discontinue antibiotics if signs of disease have resolved by 24 hours of treatment and cultures are negative. Otherwise, make individualized decision. 9. Timing of discharge should be individualized to needs of mother and infant.
* Moderately ill: Infant who has persistent tachycardia (heart rate > 160); temperature instability; perfusion problems in the delivery room requiring intravenous fluids; poor feeding; neurological signs (including lethargy or apnea); and/or mild respiratory signs (grunting, flaring, retracting; intermittent oxygen saturations < 92% in room air).
*Asymptomatic
Controversy exists over optimal criteria for maternal antibiotic therapy and the management of infants born to high-risk mothers. There is also a significant rate of missed opportunities for antibiotic treatment in high-risk mothers.10-12 One study found that approximately one-third of infants with GBS disease were born to mothers who did not receive antibiotics but who met CDC criteria for antibiotic therapy.l1An appreciable rate of delayed initiation of antibiotics in symptomatic infants also exists. l0 At the same time, a large number of newborns (~14%) undergo an evaluation and/or treatment for infection (rule out sepsis), but never become ill.13 Rule out sepsis is the most common NICU discharge diagnosis and accounts for approximately 25% of all NICU days in Kaiser Permanente Northern California. 10,14,15
Recent studies have clarified some of these issues. Increased risk for infection occurs at lower temperature and shorter length of rupture of membranes (ROM) than the cutoffs selected by the CDC.2,16,17 The role of erythromycin prophylaxis has been questioned.13 The onset of neonatal infection has been shown to occur almost exclusively in the first day of life. 10,11 The complete blood count (CBC) criteria that identify neonates at risk should be based on the absolute neutrophil count (ANC)10,18,,19rather than commonly used norms (e.g. those of Manroe et al., Rodwell et al.).20,21
Based on recent studies, this guideline recommends: * earlier initiation of maternal antibiotics * increased emphasis on neonatal clinical signs * earlier discontinuation of hospital observation
Additionally, recommendations are made concerning the laboratory workup of neonates and choice of antibiotics in mothers.
Scope of Guideline This guideline is intended for the large group of deliveries at gestational age ³ 35 weeks and for infants ³ 2000 grams. Newborns who are more premature or of lower birth weight should be managed in consultation with a neonatologist.
These evidence-based recommendations concern: * identification of mothers who will benefit from intrapartum antibiotics * extent of workup for infection in infants during the first 3 days of life * identification of infants who will benefit from antibiotics * choice of antibiotics * length of expectant antibiotic therapy pending confirmation of infection
This guideline addresses important areas of clinical practice, but is not intended to provide a comprehensive scheme of infection prevention and management. The recommendations are limited to those areas where there is compelling evidence. Clinical situations will occur that require variation from this guideline and individualized decisions for optimal patient care.
Various risk-based protocols have been proposed to reduce the risk of infection while minimizing the effects of antibiotic overuse. Though some protocols include GBS screening, the high carriage rate of GBS (~20%), the logistical limitations of this method, as well as its possible overemphasis on only one bacterial cause of disease, lead to strategies based on risk factors readily determined in the intrapartum period. One or more of these risk factors is present in approximately 25% of deliveries.27
Intrapartum antibiotics are strongly recommended in the following settings: * Chorioamnionitis.2,28 * ROM ³18 hours. The risk for maternal and neonatal infection increases with the duration of ROM.13 The risk increases steeply after 12 hours, and especially after 18 hours.2,16,28 Because implementation of a physician order takes time, consideration of antibiotic therapy should start at 12-16 hours to ensure that antibiotics are given by 18 hours. This strategy minimizes the number of labors progressing to a point where, without antibiotics, the risk for infection is significant.
* Maternal temperature ³ 38ºC (100.4ºF). A two-fold increase in infection risk can be seen even at temperatures as low as 37.5ºC (99.5ºF)16 Maternal temperatures of 38.6ºC (101.5ºF) or above had an attack rate of 6.4%.10
*Prematurity. An infant born at 34-36 weeks has twice the risk of early onset GBS than a term infant. The risk doubles for each two weeks of increasing prematurity.28
*Maternal GBS bacteriuria. This is associated with a high GBS colonization rate, and increases the risk of neonatal GBS infection.2,17,29 The attack rate in infants born without intrapartum antibiotics has been reported as high as 8%.
*Maternal GBS rectal or vaginal carriage. In the absence of other intrapartum risk factors, the risk of neonatal sepsis is low (~ 0.08%); the risk is ten-fold higher in the presence of fever, prematurity, or PROM.30 Since this guideline recommends chemoprophylaxis in all patients with intrapartum risk factors, rectovaginal screening for the remaining low-risk group is not routinely recommended. However, if a patient is known to be a GBS carrier, the risk of neonatal GBS sepsis could be reduced further by chemoprophylaxis. Parenthetically, a case has even been made for universal intrapartum antibiotic chemoprophylaxis.31
*Prior sibling with GBS. Though not well-quantified, the risk appears to be elevated.31,32
Neonatal sepsis may also be more frequent in certain other settings including: spontaneous ROM (before labor in premature infants) 34,35 multiple gestation (though this has been challenged) 2,6 gestational diabetes,10 fetal asphyxia or acidosis8,10,,36 and meconium staining.37 The efficacy of intrapartum antibiotics in these settings has not been quantified.
Suggested Intrapartum Antibiotics Antibiotic Advantages Disadvantages Ampicillin Part of optimum for treatment of true chorioamnionitis. Antibiotic resistance may be developing, especially in E. coli. Penicillin Optimum for prophylaxis. Not indicated for treatment of chorioamnionitis. Clindamycin Useful where penicillin allergy is present. Clinical efficacy not available from published studies. 5% of GBS isolates resistant. Cefazolin Useful where penicillin allergy is present Clinical efficacy not available from published studies. Gentamicin In conjunction with ampicillin, very broad spectrum attained. Nephrotoxicity and ototoxicity: levels may be required. The optimal timing of antibiotics before delivery has not been determined,2,3 but is likely to be more than 2-4 hours before delivery.38 Pharmacokinetic data concerning amniotic fluid levels support the dosing recommendations listed earlier.39-45 Erythromycin has been excluded as a recommended intrapartum antibiotic because of unclear efficacy in this setting. 3 NEONATAL MANAGEMENT Neonatal management affects the outcome of infected infants. It is critical to identify infected newborns quickly due to the rapid onset of infection. Most patients are symptomatic by 6 hours, over 90% by 12 hours, and > 95% by 24 hours8,11 The challenge confronting perinatal caregivers is identifying high-risk infants from among the large majority of infants who are well from birth or who have brief, self-limited findings in the delivery room.Initiation of Antibiotics Two groups of newborns are at extreme risk for infection (50-100 times the population rate). * Those who are critically ill (see page 2) almost always require presumptive antibiotics. 10,46 * Those whose mothers had intrapartumfever ³ 38.6'C (101.5ºF) also appear to have a markedly elevated risk in some studies. 10 Since this latter group represents only ~1.5% of total deliveries, presumptive antibiotic therapy may also be prudent.
The risk of infection is less clear in infants with moderate signs of illness (pallor, grunting, flaring, retractions, lethargy, desaturation, persistent tachycardia) that persist beyond the first minutes after birth. 10,46 The exact timing of laboratory workup and antibiotics should be individualized, based on the number and severity of risk factors and clinical findings.
These infants should have a CBC and blood culture obtained. Antibiotic therapy should be initiated if persistent clinical signs last for more than 4 hours or clinical signs appear intermittently and the ANC is < 10,000. Having a low ANC (< 10,000 at 4 hours of age) is not an absolute indication for antibiotic treatment. However, clinicians must note that the risk of sepsis in infants with low ANCs is 2-3 times as high as that of newborns with normal or high ANCs. 10
In general, asymptomatic infants whose mothers received intrapartum antibiotic therapy 4 hours prior to delivery do not require antibiotic therapy since their risk of infection is less than 1% (with the exception of those whose mothers had high fever). 10
Asymptomatic infants whose mothers had intrapartum risk factors but did not receive intrapartum antibiotic therapy present a special case. Although the risk for infection in these infants is low (< %), it is still as much as 5-10 times higher than the population rate.10 For this reason they should have serial examinations to identify early signs of infection and facilitate early treatment. A CBC for determination of ANC and blood culture may be considered. There may be a place for presumptive antibiotic therapy in selected asymptomatic infants. 13,30
No changes are recommended in the length of antibiotic therapy in those cases where infants have positive cultures (7-21 days depending on type and severity of infection). The length of antibiotic therapy for infants with negative cultures but who have persistent illness, should be determined on an individualized basis.
Commonly used criteria, such as those recommended by Manroe et al. and Rodwell et al., misclassify many infants and lead to both over- and under-estimation of the risk for infection. 18 Use of the ratio of immature to total neutrophil (I:T ratio) is not recommended, as this test is statistically unreliable, has poor inter-rater agreement, and has low sensitivity.18,19
Urine bacterial antigens and surface cultures should not be used, as their performance is poor. 52,53 C-reactive protein has not yet been validated for use in identifying babies for whom antibiotics should be started, though research is ongoing in this area. 54 Because of the low rate of meningitis many authors do not recommend routine lumbar puncture in the absence of a positive blood culture or localizing findings. 55-58 The low rate of urinary tract infection leads most authors to recommend against routine urine culture.59,60 Endotracheal tube aspirate cultures taken at the time of initial intubation may be useful in the diagnosis of neonatal pneumonia.61
†Federal and state law require health maintenance organizations and insurance companies who provide maternity coverage to provide for a minimum of 48 hours of inpatient care following a normal vaginal delivery and not less than 96 hours following a delivery by cesarean section. A shorter length of stay is allowable if the decision is made by the treating physician in consultation with the mother, and if the plan or insurance carrier provides a post discharge follow-up visit for the mother and newborn within 48 hours of the discharge. (References: Newborns' and Mothers' Health Protection Act, 1996; Maternity Hospital Stay Act, 1997)CALCULATION OF ABSOLULTE NEUTROPHIL COUNT (ANC) Example
WBC =White blood cell count (per mm3 WBC = 10,000
Neutrophil line =Sum of % of segmented neutrophils, Seg = 40% bands, and metamyelocytes Bands =10%
ANC =WBC x Neutrophil line x .0 ANC = 10,000 x (40+ 10) x..01=5.000
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Yancey MK, Duff P, Kubilis P, et al. Risk factors for neonatal sepsis. Obstet Gynecol 1996 Feb;87 (2): 188-94. Wood EG, Dillon HCJr. A prospective study of group B streptococcal bacteriuria in pregnancy. Am] Obstet Gynecol 1981 Jul l;l40(5):515-20. Benitz WE, GouIdJB, Druzin ML. Preventing early-onset group B streptococcal sepsis: strategy development using decision analysis. Pediatrics 1999Jun;103(6):e76. Available at http://u)u)iu .pediatrics, org/cgi/confenf/full/ 103/6/e76 Rouse DJ, Goldenberg RL, Cliver SP, et al. Strategies for the prevention of early-onset neonatal group B streptococcal sepsis: a decision analysis. Obstet Gynecol 1994 Apr;83(4):483-94. Carstensen H, Christensen KK, Grennert L, et al. Early-onset neonatal group B streptococcal septicaemia in siblings.j Infect 1988 Nov;17(3):201-4. Faxelius G, Bremme K, Kvist-Christensen K, et al. Neonatal septicemia due to group B streptococci-perinatal risk factors and outcome of subsequent pregnancies. J PerinatMed 1988;l6(5-6):423-30. Newton ER, Clark M. Group B streptococcus and preterm rupture of membranes. Obstet Gynecol 1988 Feb;71 (2): 198-202. Morales WL Angel JL, O'Brien WF, et al. Use of ampicillin and corticosteroids in premature rupture of membranes: a randomized study. Obstet Gynecol 1989 May;73(5 Pt l):721-6. Montgomery DM, Stedman CM, Robichaux AG 3d, et al. Cord blood gis patterns identifying newborns at increased risk of group B streptococcal sepsis. Obstet Gynecol 1991 Nov;78(5Ptl):774-7. Spaans WA, Knox AJ, Koya HB, et al. Risk factors for neonatal infection. AustN ZJ Obstet Gynaecol 1990 Nov;30(4):327-30. de Cueto M, Sanchez MJ, Sampedro A, et al. Timing of intrapartum ampicillin and prevention of vertical transmission of group B streptococcus. Obstet Gynecol 1998 Jan;91(l):112-4. MacAulay MA, Charles D. Placental transfer of cephalothin.dm/ Obstet Gynecol 1968 Apr; 100(7) :940-6. Maberry MC, Trimmer KJ, Bawdon RE, et al. Antibiotic concentration in maternal blood, cord blood and placental tissue in women with chorioamnionitis. Gynecol Obstet Invest 1992;33(3):185-6. Matsuda S, Fujita M, MatsumotoJ, et al. Placental transfer and clinical evaluation of antibiotics. In: Current Chemotherapy. Proceedings of the 10th International Congress of Chemotherapy, September 1977. Washington DC: American Society of Microbiology, 1978. Bloom SL, Cox SM, Bawdon RE, et al. Ampicillin for neonatal group B streptococcal prophylaxis: how rapidly can bactericidal concentrations be achieved? AmJ Obstet Gynecol 1996 0ct;175(4 Pt l):974-6. Hirsch HA, Dreher E, Perrochet A, et al. Transfer of ampicillin to the fetus and amniotic fluid during continuous infusion (steady state) and by repeated single intravenous injections to the mother. Infection 1974;2(4):207-12. Bray RE, Boe RW, Johnson WL. Transfer of ampicillin into fetus and amniotic fluid from maternal plasma in late pregnancy. Am] Obstet Gynecol 1966 Dee l;96(7):938-42. Amstey MS, Gibbs RS. Is penicillin G a better choice than ampicillin for prophylaxis of neonatal group B streptococcal infections? Obstet Gynecol 1994 Dec;84(6): 1058-9. Spector SA, Ticknor W, Grossman M. Study of the usefulness of clinical and hematologic findings in the diagnosis of neonatal bacterial infections. Clm Pediatr (Phila) 1981 Jun;20(6):385-92. Hayani KC, Hatzopoulos FK, Frank AL, et al. Pharmacokinetics of once-daily dosing of gentamicin in neonates./ Pediatr ggii Jul;131(l Pt l):76-80. Skopnik H, Wallraf R, Nies B, et al. Pharmacokinetics and antibacterial activity of daily gentamicin. Arch Dis Child 1992 Jan;67(ISpecNo):57-6l. Thureen PJ,. Reiter PD, Gresores A, et al. Once- versus twice-daily gentamicin dosing in neonates >/=34 weeks' gestation: cost- effectiveness analyses. Pediatrics 1999 Mar;103(3):594-8. Lundergan FS, Kirn EH, Cohen RS. Once-daily gentamicin dosing in newborn infants. Pediatric~1999Jun;103(6):1228-34. OrtezJH, Vannier AM, Wong VK, et al. Time to positivity of blood culture bact/alert blood system in neonates. General meeting, American Society of Microbiology. May 1998. [abstract/poster]
Sanchez PJ, SiegelJD, Cushion NB, et al. Significance of a positive urine group B streptococcal latex agglutination test in neonates.JPediatr 1990Apr;ll6(4):601-6. Ascher DP, Wilson S, MendiolaJ, et al. Group B streptococcal latex agglutination testing in neonates.JPediatr 1991 Sep;119(3):458-6l. Benitz WE, Han MY, Madan A, et al. Serial serum C-reactive protein levels in the diagnosis of neonatal infection. Pediatrics 1998 0ct;102(4):e4l. Available athttp://u)ww. pediatrics, org/cgi/confent/full/l 02/4/e41 Wiswell TE, Baumgart S, Cannon CM, et al. No lumbar puncture in the evaluation for early neonatal sepsis: will meningitis be missed? Pediatrics 1995 Jun;95 (6) :803-6. MacMahon P.Jewes L, de LouvoisJ. Routine lumbar punctures in the newborn-are they justified? EurJPediatr 1990Aug;l49(ll): 797-9. SchwersenskiJ, Mcintyre L, Bauer CR. Lumbar puncture frequency and cerebrospinal fluid analysis in the neonate. ArnJDis Child 1991 Jan;l45(l):54-8. Johnson CE, WhitwellJK, Pethe K, et al. Term newborns who are at risk for sepsis: are lumbar punctures necessary? Pediatrics 1997 Apr;99 4):e10. Available athttp://u)u)u). pediatrics, org/cgi/contenf/full/99/4/el 0 Visser VE, Hall RT. Urine culture in the evaluation of suspected neonatal sepsis. JPediatrl979Apr;94(4):63-8. DiGeronimo RJ. Lack of efficacy of the urine culture as part of the initial workup of suspected neonatal sepsis. Pediatr Infect DisJ 1992 Sep;ll(9):764-6. Sherman MP, Chance KH, Goetzman BW. Gram's stains of tracheal secretions predict neonatal bacteremia. m JDi Child 1984 Sep; 138(9) :848-50.
ACKNOWLEDGMENTS The Neonatal Sepsis Guideline was developed by the following Kaiser Permanente clinicians and staff in Northern California, Southern California and Hawaii. Clinical Leaders James Kantor, MD; Pediatrics, San Francisco David Braun, MD; Pediatrics/NICU, Woodland Hills Work Group Jocelyn Alcantara, MD; Pediatrics, Hayward Chynna Bantug, MD; Pediatrics, Santa Teresa Gardner Bernis, MD; Pediatrics, Honolulu Randy Bergen, MD; Pediatrics, Walnut Creek Gabriel Escobar, MD; Division of Research, Oakland Michael Jennis, MD; Pediatrics, Oakland/Alta Bates Stephen McMurtry, MD; Pediatrics, Vallejo Scott Puza, MD; Ob/Gyn, Walnut Crcek Christine Retta, RNC, MSN, NNP; Nursing Administration, Walnut Creek Carlene Wong, MD; Pediatrics, Santa Clara Advisory Group Hector Anguiano, MD; Ob/Gyn, Baldwin Park Patricia Bromberger, MD; Special Care Nursery, Zion/SanDiego Maria Gardner; Division of Research, Oakland Jean Lawrence, ScD, MPH, MSSA; Research & Evaluation, Los Robles Joseph Ouzounian, MD; Perinatology, Baldwin Park Brian Saunders, MD; Pediatrics, Zion/SanDiego Jerry Yu, MD; Ob/Gyn, Fontana Project Management Philip Bellman, MPH; Department of Quality & Utilization Mary Davis; Department of Quality & Utilization Editing ~ Graphic Design Linda Bine, TPMG Communications GailHolan, Curvey Graphic Design
CONTACT INFORMATION Kaiser Permanente Northern California TPMG Department of Quality and Utilization 1800 Harrison Street, 4th Floor, Oakland, CA 94612 510-987-2950 or tie-line 8-427-2950 To obtain more information about KPNC Clinical Practice Guidelines, printed copies, or permission to reproduce any portion, please contact the TPMG Dept. of Quality & Utilization, or send an e-mail message to clinicaLguidelmes@kp.org KPNC Clinical Practice Guidelines can be viewed on-line on the Kaiser Permanente Northern California intranetwebsite at http://clinical-library.ca.kp.ogg This website is accessible only from the Kaiser Permanente computer network.
CME Credit. Continuing Education Credit for physicians and nurses is available for review of this guideline. The CME Pro-Test and Post-Test is available on-line at http://clinical-library.ca.kp.org or by calling 510-987-2950 or tie-line 8-427-2950.
Disclaimer. The Permanente Medical Group (TPMG) Clinical Practice Guidelines have been developed to assist chnicians by providing an analytical framework for the evaluation and treatment of selected common problems encountered in patients. These guidelines are not intended to establish a protocol for all patients with a particular condition. While the guidelines provide one approach to evaluating a problem, clinical conditions may vary significantly from individual to individual. Therefore, the clinician must exercise independent judgment and make decisions based upon the situation presented.While great care has been taken to assure the accuracy of the information presented, the reader is advised that TPMG cannot be responsible for continued currency of the information, for any errors or omissions in this guideline, or for any consequences arising from its use.
© Copyright 1999 The Permanente Medical Group, Inc.
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