Q&As About Implementing the 2010 Guidelines for Neonatal Providers
Algorithm for secondary prevention of early-onset group B streptococcal (GBS) disease among newborns
Q: What does the neonatal algorithm address?
A: The neonatal algorithm provides guidance on which newborns require full diagnostic evaluations, limited diagnostic evaluations, antibiotic therapy, and observation for the purpose of secondary prevention of early-onset GBS disease. For newborns requiring observation, it also includes guidance on when infants can be discharged to be observed at home instead of being observed in the hospital. The recommended management depends on whether the newborn shows signs of neonatal sepsis or was exposed to maternal chorioamnionitis, whether the mother had an indication for GBS intrapartum antibiotic prophylaxis and received adequate GBS intrapartum antibiotic prophylaxis, the duration of the mother’s rupture of membranes, and the newborn’s gestational age.
Q: Where can I find the neonatal algorithm for secondary prevention of early-onset GBS disease?
Q: Which infants does the neonatal algorithm apply to?
A: The algorithm applies to all newborns.
Q: What qualifies as adequate GBS intrapartum antibiotic prophylaxis in a woman who either had a positive GBS screening test or unknown GBS status and gestational age <37 weeks, intrapartum temperature ≥ 100.4°F, or rupture of membranes ≥18 hours?
A: The mother should have received ≥4 hours of intravenous penicillin, ampicillin, or cefazolin prior to delivery. If she received penicillin, she should have initially received 5 million units IV then 2.5-3.0 million units IV every 4 hours until delivery. If she received ampicillin, she should have received 2 grams IV in the initial dose followed by 1 gram IV every 4 hours until delivery (with the exception of women with preterm premature rupture of membranes, who may have received 2 grams IV in the initial dose followed by 1 gram IV every 6 hours) For cefazolin, she should have received a first dose of 2 grams IV followed by 1 gram IV every 8 hours until delivery.
Q: Why does a mother with an indication for intrapartum prophylaxis need to have received antibiotics for at least 4 hours to be considered to have received adequate intrapartum prophylaxis?
A: Beta-lactam antibiotics for GBS prophylaxis administered for at least 4 hours before delivery have been found to be highly effective at preventing neonatal surface colonization with GBS as well as invasive early-onset GBS disease. Shorter durations may have some benefit but have not been established as effective in preventing early-onset GBS disease.
Q: Why are penicillin, ampicillin, and cefazolin considered adequate for GBS intrapartum antibiotic prophylaxis while clindamycin and vancomycin are considered inadequate for GBS intrapartum antibiotic prophylaxis?
A: The efficacy of penicillin and ampicillin as intravenously administered intrapartum agents for the prevention of early-onset neonatal GBS disease has been demonstrated in clinical trials and large observational studies. The efficacy of alternatives to penicillin or ampicillin has not been evaluated. However, cefazolin has similar pharmacokinetics and dynamics to penicillin and ampicillin and achieves high intra-amniotic concentrations. In contrast, data on the ability of clindamycin, erythromycin, and vancomycin to reach bactericidal levels in the fetal circulation and amniotic fluid are very limited.
Q: What qualifies as a limited evaluation?
A: A limited evaluation includes a blood culture (at birth), and a complete blood count (CBC) with differential and platelets. The CBC with differential and platelets can be drawn at birth; however some experts recommend that it be drawn at 6-12 hours of age.
Q: Why do some experts recommend waiting several hours before ordering a complete blood count with differential and platelets in an infant with suspected sepsis?
A: The sensitivity of a complete blood count with differential and platelets is lowest immediately after birth, and its performance as a screen for sepsis can be improved by obtaining the blood specimen between 6 and 12 hours of life.
Q: What qualifies as a full evaluation?
A: A full diagnostic evaluation includes complete blood count with differential and platelets, blood culture, chest radiograph (if respiratory abnormalities are present), and lumbar puncture (if the patient is stable enough to tolerate procedure and sepsis is suspected).
Q: What do I do if an infant born to a mother with a negative GBS screening test looks ill?
A: If signs of sepsis develop in any infant, regardless of their mother’s GBS status, a full diagnostic evaluation should be done and antibiotic therapy initiated.
Q: Is a lumbar puncture mandatory for infants who are symptomatic?
A: Any infant with symptoms of sepsis should receive a lumbar puncture as long as they are stable enough to tolerate the procedure. They should also have a complete blood count with differential and platelets, a blood culture, and a chest radiograph performed as part of a full diagnostic evaluation.
Among infants with signs of early-onset disease, the detection of GBS can be increased by performing culture of both blood and cerebrospinal fluid. Blood cultures can be sterile in as many as 15%-33% of newborns with meningitis, and the clinical management of an infant with abnormal CSF findings differs from that of an infant with normal CSF.
Q: Is there value in measuring acute phase reactants (e.g., C - reactive protein) in infants with suspected sepsis?
A: Measuring acute phase reactants is not considered part of the full diagnostic evaluation of infants with suspected sepsis. The sensitivity and specificity of these tests are too low in infants for them to be consistently useful in decisions to initiate treatment for suspected sepsis. However, some experts have argued that acute phase reactants may be useful in decisions to stop antibiotic treatment for suspected cases of sepsis.
Q: How soon can antibiotics be discontinued after birth if an infant with suspected sepsis becomes asymptomatic and the mother received intrapartum antibiotics which might limit the accuracy of a blood culture?
A: Clinicians should follow the usual standard of care in making decisions on length of treatment of infants with suspected sepsis. CDC has no recommendations on the length of treatment of infants with suspected sepsis.
Q: Which antibiotics should be used to treat an infant with suspected sepsis whose mother was GBS-negative? What if the mother was GBS-positive or has unknown GBS status?
A: Regardless of the mother’s GBS status, antibiotic therapy for any infant with signs of sepsis should include ampicillin for GBS, antibiotics that cover Escherichiacoli, and antibiotics that take into account local resistance patterns.
Q: Do well-appearing infants whose mother had suspected chorioamnionitis need antibiotics and a limited evaluation?
A: All well-appearing infants whose mothers had suspected chorioamnionitis (regardless of the mother's GBS status) should undergo a limited diagnostic evaluation with blood culture (at birth), and a complete blood count with differential and platelets and receive antibiotics pending culture results and. Consultation with obstetric providers to assess whether chorioamnionitis was suspected is important in determining neonatal management.
Q: How long do I need to observe a full term well-appearing infant whose mother had an indication for GBS intrapartum antibiotic prophylaxis and received adequate intrapartum antibiotic prophylaxis?
A: The infant should be observed for ≥ 48 hours. If ≥37 weeks’ gestation, observation may occur at home after 24 hours if other discharge criteria have been met, access to medical care is readily available, and a person who is able to comply fully with instructions for home observation will be present. If any of these conditions is not met, the infant should be observed in the hospital for at least 48 hours and until discharge criteria are achieved. If signs of sepsis develop, a full diagnostic evaluation should be done and antibiotic therapy initiated.
Q: If a full term infant appears well but his or her mother had an indication for GBS intrapartum antibiotic prophylaxis and did not receive adequate intrapartum antibiotic prophylaxis, what is the recommended management?
A: The recommended management depends on whether the mother had prolonged rupture of membranes. If the duration of membrane rupture before delivery was ≥18 hours, then the infant should undergo a limited evaluation (including blood culture and CBC with differential and platelet count). If the infant is well-appearing, full-term (≥37 weeks), and the duration of membrane rupture before delivery was <18 hours before delivery, then the infant should be observed for at least 48 hours in the hospital. If signs of sepsis develop, a full diagnostic evaluation should be done and antibiotic therapy initiated.
Q: If a mother had an indication for GBS intrapartum antibiotic prophylaxis, received adequate intrapartum antibiotic prophylaxis, and gave birth to a preterm (<37 weeks' gestation), well-appearing infant, how long does the infant need to be observed in the hospital?
A: At least 48 hours in the hospital for the purpose of secondary prevention of early-onset GBS disease. If signs of sepsis develop, a full diagnostic evaluation should be done and antibiotic therapy initiated. You may choose to keep the infant in the hospital longer for other reasons.
Q: What is the recommended management for a well-appearing infant whose mother had an indication for GBS intrapartum antibiotic prophylaxis and did not receive adequate intrapartum antibiotic prophylaxis?
A: The recommended management would depend on the gestational age and duration of membrane rupture. If the infant is <37 weeks gestational age or the duration of membrane rupture was >18 hours, the infant should undergo a limited evaluation (including blood culture and CBC with differential and platelet count). If the infant is ≥37 weeks and the membranes were ruptured for <18 hours, then the recommended management is observation for >48 hours. In either case, if signs of sepsis develop, a full diagnostic evaluation should be done and antibiotic therapy initiated.
Q: Are efforts to prevent early onset GBS disease leading to increased E.coli sepsis among newborns?
A: Decreases in the incidence of early-onset GBS sepsis have not been accompanied by increases in incidence of early-onset sepsis caused by other pathogens. Most studies, including population-based multicenter studies, have found stable or decreasing rates of non-GBS early-onset sepsis during a period of increasing use of intrapartum antibiotic prophylaxis for GBS. Increases in invasive E. coli infections have been reported among preterm and low-birth-weight or very low-birth-weight infants, but the trends have not been consistent over time or across studies. For example, a multicenter study of sepsis in preterm infants that reported an increase in E. coli incidence during 1991-1993 and 1998-2000 found stable rates of E. coli sepsis during 2002-2003.
Q: Is the decreased rate of early-onset GBS disease since the early 1990s representative of a true decline in the neonatal GBS disease burden, or does it just reflect a decreased yield of blood cultures in the setting of intrapartum antibiotics?
A: Nationally representative hospital discharge diagnostic code data demonstrated a steady decrease in clinical sepsis rates during 1990-2002, with a marked decline in clinical sepsis among term infants following the issuance of the 1996 GBS prevention guidelines; these data suggest that the observed decline in early-onset GBS disease is a result of prevented cases of illness and not simply of sterilization of neonatal blood cultures as a result of exposure to maternal antibiotics.
Q: Has use of intrapartum antibiotic prophylaxis changed the clinical picture of early-onset GBS disease?
A: Several studies conducted since 1996 have found no significant difference in the clinical presentation of early-onset GBS disease between infants exposed to intrapartum antibiotics and those not exposed. Approximately 90% of cases of early-onset GBS disease continue to manifest within the first 24 hours of life.
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