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Incidence | Methodology | Knowledge | Skills | Resources | Management | Summary | Algorithm | References
PRACTICE PARAMETER for IDENTIFICATION and MANAGEMENT
of EARLY NEONATAL SEPSIS.
Alastair A. Hutchison, M.B.Ch.B., F.R.A.C.P.
Practice Parameter: Identification and Management of Early Neonatal Sepsis.
Incidence, Mortality / Morbidity of Early Neonatal Sepsis. | Return to Top
Sepsis in the neonate occurs in 1-4 / 1000 births, the majority being due to infection with group B streptococcus (GBS) [1]. Recent reports have indicated a decrease in mortality from GBS infection but it is still significant, approximately 15% [2]. Preterm neonates whose mothers have preterm premature rupture of the membranes (pPROM) and/or chorioamnionitis are at greatest risk. For survivors, the major long term sequelae are those associated with meningitis which currently occurs in less than 10% of all GBS cases [2].
The management proposed in this practice parameter was based, when possible, upon published data. The studies upon which reliance was placed were 1) randomized controlled clinical trials which provided strong evidence of a therapeutic effect or 2) observational studies performed in multiple centers which provided reasonable evidence of a therapeutic effect. Observational data from one center / author was viewed as weak evidence and identified as such if included in the development of the practice parameter. Where no studies exist to provide guidance to the clinician for therapy, a consensus was developed initially by a group of participants and finally by the larger body of clinicians involved in the process of developing the practice parameter. Published recommendations from national committees (e.g. American Academy of Pediatrics) are cited.
Definition of Early Neonatal Sepsis.
Early neonatal sepsis is that proven by bacterial culture or strongly suspected on the basis of clinical findings and laboratory investigations on days 0-6 after birth.
Goals of identification and management of the neonate at-risk of sepsis.
· To prevent, if possible, early onset infection and /or minimize the effects of bacterial infection for the neonate.
· To reduce the attendant effects of neonatal infection for the family, namely emotional stress and separation from the baby.
· To minimize the medical costs.
Required Knowledge, Skills and Resources.
The health care team caring for newborn babies requires a specific knowledge of the following appropriate to their training:
· the pathophysiology of neonatal sepsis, especially septic shock.
· the signs of neonatal sepsis, including respiratory distress, shock, apnea, seizures, lethargy, temperature abnormalities and feeding intolerance.
· the perinatal risk factors associated with increased risk of neonatal sepsis.
· the interpretation of white cell counts, cerebrospinal fluid data, and culture results.
· the pharmacology and dosages of antibiotic therapy.
· the assessment of adequacy of perfusion.
· the assessment of adequacy of oxygenation.
· Ability to educate the mother / primary caregiver of signs in the baby which require medical attention.
· Ability to assess and monitor the sick neonate, including measurement of blood pressure, temperature, heart rate, respiratory rate and the use of a pulse oximeter.
· Ability to draw venous blood for laboratory investigations.
· Ability to give intravenous fluids and medications.
· Ability to resuscitate the sick neonate.
· Availability of experienced staff to deal with rapid onset of septic shock.
· Availability of experienced staff to provide frequent monitoring of well babies rooming-in with their mothers.
· Availability of a nursing area with appropriate heating and lighting for investigation and treatment of a baby with sepsis or suspected of having sepsis.
· Availability of an identified regional center: 1) for consultation with a specialist in neonatology and / or pediatric infectious disease; 2) for referral.
· Capability to provide antibiotic therapy, oxygen and fluids as required.
· Capability to assess oxygen saturation, and monitor blood pressure, heart rate, respiration and temperature.
This practice parameter addresses those management aspects dealing with identification of the neonate at risk and initial management of the baby with neonatal sepsis, mainly in the normal newborn nursery within the first 72 hours after birth. Neonatal resuscitation, including adequacy of oxygenation and the treatment of volume depletion, are covered in the Neonatal Resuscitation Program (American Academy of Pediatrics / American Heart Association) and are not included. Intensive care of the baby with sepsis, e.g. artificial ventilation, and administration of non-antibiotic therapy for sepsis e.g. intravenous gammaglobulin, are not covered. Perinatal management of syphilis, tuberculosis, gonococcus and chlamydia are not discussed.
Importance of Early Identification of Neonate At-Risk of Sepsis.
The early identification of the baby at risk and consideration for therapy are important in: 1) preventing or reducing the illness; 2) minimizing separation of baby and family and reducing the family stresses of having a severely sick neonate and 3) reducing the medical and thus societal costs for the intensive care these babies require. The importance of early identification cannot be over stressed as the onset of the clinical problem is frequently sudden and its progression to septic shock devastatingly rapid. However, the initial signs of sepsis can be both subtle, and thus not-recognized, or non-specific, and thus not given adequate weight. These are key issues given the low incidence of neonatal sepsis and the fact that "well" babies room-in with their mothers.
Management Strategies.
The current management strategies are as follows:
1. identification and antibiotic treatment of the mother whose baby has an increased risk of neonatal sepsis - intrapartum antibiotic chemoprophylaxis or therapy for known infection(s);
2. identification of well neonates without signs of sepsis who were born to mothers with risk factors and who are thus at increased risk of sepsis;
3. identification of the neonate with signs of sepsis who requires immediate investigation, careful observation and specific antibacterial therapy.
1. Maternal Antibiotic Treatment for Risk Factors Identified Prior to Birth.
The 1992 American Academy of Pediatrics (AAP) recommendations for GBS chemoprophylaxis [3] are based on: 1) the risk of neonatal bacterial infection as determined by the presence or absence of prenatal risk factors for in utero and natal exposure to GBS [4-6]; 2) the efficacy of selective intrapartum treatment of the mother colonized with GBS in reducing neonatal GBS infection [1].
The incidence of neonatal infection in term babies of GBS carrier (GBS +) mothers without other risk factors is approximately 1/250 - 1/1000 with a mortality of ~3% [7,8]. By contrast in the extremely low birthweight baby (501-1000g) the incidence is ~1/40 with a mortality of 90% % [7]. The incidences and mortalities for the birthweight groups 1001-2000g and 2001-2500g are ~1/125 and 27% and ~1/250 and 33% respectively % [7]. The incidence following prolonged rupture of the membranes (PROM) varies with duration affecting <1/500 live births if the PROM is <18 hours and ~1/100 if the PROM is >48 hours [5-7,9]. This risk of sepsis for the neonate of the GBS+ mother increases markedly if several prenatal risk factors co-exist [5,6]. It is especially marked if the baby is preterm and pPROM and/or chorioamnionitis are present when the risk of neonatal infection rises to ~1/10 and in some series ~1/5 live births [5,8,10]. The presence of one or more of these risk factors accounts for 74% of all cases and 94% of the mortality [7].
The majority of cases (84%) present in the first 24 hours after birth [7]. Penicillin administration to normal neonates in the delivery room decreases the rates of GBS infection in some nurseries [11]. However, it is not effective in low birthweight infants born with bacteremia [11]. A prenatal strategy is the key to minimizing neonatal sepsis and its associated mortality and morbidity. Randomized controlled trials of selective administration of intrapartum antibiotic therapy for mothers prenatally colonized with GBS showed that this therapy is effective in reducing colonization with GBS and GBS bacteremia but not completely eliminating early onset GBS infection [8,11-15]. It should be noted that in one of these trials [8] neonates whose mothers were given intrapartum antibiotics also received antibiotics postnatally until blood cultures were reported negative. While bactericidal antibiotic levels are present in the fetus within one hour of maternal antibiotic administration [16], the concentration of antibiotic in the amniotic fluid continues to rise for 3 hours [15]. Thus a duration of antibiotic therapy of ³ 4 hours is deemed effective in reducing neonatal exposure to GBS [3]. Intrapartum antibiotic therapy is given if genital GBS is identified following screening at 35-37 weeks, a strategy which will identify ~90% of mothers who will be GBS+ at delivery [17]. Alternatively, it is given based on the presence of risk factors, a strategy which is designed to detect and treat ~70% of mothers who are GBS+ at delivery [17].
Intrapartum antibiotic therapy (GBS Intrapartum Antimicrobial Prophylaxis [IAP]) is recommended for the following risk factors:
1. GBS + or with GBS bacteriuria this pregnancy
2. Sib with GBS in previous pregnancy (4)
3 Premature rupture (i.e. before onset of labor) of the membranes at < 37 weeks.
4. Preterm labor (< 37 completed weeks).
5. Pyrexia during labor. (³ 38oC)
6. Rupture of the membranes > 18 hours at any gestation, assess likely duration of labor at 12 hours so that IAP can be initiated if rupture expected to extend >18 hours.
When risk factors are present but genital and urinary cultures for GBS are negative, the use of IAP will be based on the physician’s experience and discussion with the mother and father. It should also be noted that even if maternal therapy is deemed adequate (>4 hours) infection can occur [3]. This is especially true if maternal chorioamnionitis and/or pPROM are present [10,18,19]. Maternal therapy for chorioamnionitis differs from GBS chemoprophylaxis given intrapartum in that different antibiotics are given to the mother both intrapartum and for a minimum of another 48 hours. Some neonates at-risk of sepsis are identified not by factors noted prior to birth but by the development of a fever in the mother postpartum.
In focusing upon the commonest cause of neonatal sepsis, GBS infection, it is very important that other pathogens causing neonatal sepsis not be forgotten. (Note: this parameter does not present the management of neonates born to mothers with known treated or untreated syphilis, gonococcus, tuberculosis or chlamydia.)
2. Management of the Well Neonate who is At-Risk of Sepsis.
The situation can arise where prenatal risk factors for neonatal bacterial infection exist but the mother does not receive chemoprophylaxis (e.g. rapid preterm delivery). Thus, the following management situations are described to reflect what can occur in practice. The approach to the evaluation and treatment of the well neonate who is at-risk of bacterial infection is based on the magnitude of the risk to the baby [6]. There are no controlled trials to provide guidelines for the management of the "well" neonate at risk of sepsis.
2.A. Sibs of Babies with GBS infection.
Evaluation and initiation of treatment of the "well" twin / same pregnancy sib of an index case with neonatal GBS infection is advised [4]. Some physicians may elect to observe such well babies if initial laboratory evaluations are normal.
The well newborn baby whose sib had GBS sepsis in a previous pregnancy should be evaluated clinically. If maternal intrapartum chemoprophylaxis was not given or inadequate (< 4 hours prior to delivery), a CBC + diff. should be performed. If abnormal the baby should be evaluated further (2.B.2.1.) and treated. Despite a normal CBC + diff., some physicians may elect to give postnatal antibiotic therapy until they are satisfied that no infection exists. If maternal IAP was adequate, the baby is term and there was no evidence of maternal chorioamnionitis, then the baby can be observed (see 2.B.1.).
2.B. Well Neonates with Risk Factors for Sepsis.
In the case of possible GBS exposure, the AAP Committee on Infectious Diseases recommendation focuses upon the gestational age and the presence or absence of clinical signs as guides for consideration for therapy [4]. Thus, in addition to a history of a sib with GBS sepsis (2.A.), the management of the well neonate at risk for any sepsis is based upon the gestational age at birth and the presence / absence of prenatal risk factors. For this practice parameter the following will be considered as neonatal risk factors for any bacterial infection.
· Mother GBS carrier (GBS +), with or without multiple births.
· Preterm birth < 37 weeks
· Rupture of membranes (ROM) at < 37 weeks without labor
· ROM ³ 18 hours (assess at 12 hours if delivery is not anticipated until > 18 hours.)
· Chorioamnionitis, which is diagnosed by the following:
1) Fever in labor ³ 38°C not clearly attributable to an extrauterine cause; uterine tenderness; fetid or cloudy amniotic fluid; maternal (> 100/min) or fetal tachycardia (> 160/min).
2) Laboratory evidence of an infection of the chorion / amnion: positive gram stain, leukocyte esterase dipstick, low amniotic fluid glucose (< 15mg%) or positive culture.
2.B.1. Well Baby < 37 weeks.
Mortality from early-onset GBS sepsis is increased in preterm as compared to term neonates [3], especially in the presence of pPROM and/or chorioamnionitis [5,8,10]. The AAP Committee [3] recommendation of November 1992 is that the preterm baby with a gestational age of < 34 weeks at risk for GBS infection be considered a candidate for empirical antibiotic therapy regardless of maternal antibiotic treatment.
Well babies ³ 34 weeks but < 37 weeks, delivered after preterm labor, should be considered for evaluation for sepsis regardless of IAP administration. The physician should consider performing a CBC and diff., especially in the more preterm neonate (£ 35 weeks). The performance of a CBC and diff. is recommended in any neonate with multiple maternal risk factors, especially pPROM and/or chorioamnionitis. There are no well defined guidelines for the management of the baby if the CBC and diff. results are normal and the baby is well (no signs). Thus, the physician may choose to observe the patient if he/she is confident that close observation and early identification of any signs can be ensured. The decision to manage the neonate by careful observation is based upon:
1) the acceptance of the risk of sepsis and confidence in employing the observational strategy - this may involve discussion with the baby’s primary caregiver(s).
2) the availability in terms of number of nurses, in-house nurse practitioners and physicians relative to the work load - factors determining response time.
3) the experience of the staff to provide careful and frequent observation of the neonate who can change from being a "well" neonate to one with septic shock in the space of a few hours - staff in hospitals which have small or low-risk delivery services may not see a case of neonatal sepsis for years.
Close observation should occur for a minimum of 48 hours and include recording of 4 hourly vital signs including blood pressure. This may be appropriate for the well baby at 36 weeks whose mother’s only risk factor is being GBS+. The CBC and diff. can be repeated after a 6-12 hour period. It is advised that the well baby remains mainly in the transitional nursery for a 24 hour period before being transferred to the mother’s room.
Especially if pPROM and/or chorioamnionitis are present in the 34-35 week neonate, the physician may choose an alternative strategy and perform investigations and treat until he/she is satisfied that no infection exists. It should be noted that, in the one randomized controlled trial which showed a decrease in clinically apparent and proven GBS infection, antibiotic therapy was continued in the neonate until the blood and surface cultures were negative. Furthermore, even with adequate IAP, there remains a risk of sepsis (~3%) in the presence of pPROM and/or chorioamnionitis [10,18,19]. However, especially in term in neonates whose mothers received IAP, it may not be justified on a cost-benefit basis to perform ~ 100 tests to detect ~3 abnormalities [18,20,21]. The physician will have to use clinical judgment for each case and consider the circumstances in which he/she practices prior to choosing an observation (expectant) or empirical treatment approach. If the CBC + diff. results are abnormal, further investigation should be performed as in 2.B.2.1., and therapy commenced.
In the well preterm baby < 37 weeks delivered by cesarean section for maternal reasons (i.e. without: 1. preterm labor; 2. premature rupture of the membranes without labor and 3. any other risk factors for sepsis), the physician may elect only to observe the patient or perform laboratory evaluation followed by either observation or therapy. The caveats for employing the observational approach are cited above. Close observation should occur for a minimum of 48 hours and include recording of 4 hourly vital signs including blood pressure. When the baby is ready for discharge, it should be ensured that 1) specific family counseling has been given, 2) a discussion of how they would access emergency care has occurred and 3) the family has the telephone number of their physician / the nursery and can contact medical care.
2.B.2. Well Baby ³ 37 weeks.
There is no strong evidence to provide guidelines for optimal management for these patients. Recommendations are empirical based upon consensus expert opinions, based initially on the nature of the maternal intrapartum antibiotic therapy:
2.B.2.1. No IAP or inadequate IAP therapy (< 4 hours prior to delivery).
For this group of well babies, it is recommended that the physician perform laboratory evaluations and employ selective treatment. This management approach recognizes concerns about the rapidity with which sepsis can develop and the subtlety of early signs which may go undetected leading to the presentation of a baby in shock. The aim of the laboratory evaluation is to decrease the risk without increasing the use of antibiotic therapy. It involves following the white cell count to detect any abnormality in the first 24 hours. One or two white cell counts are obtained at 6-12 hours after birth and perhaps at 6-12 hours thereafter. Delaying the initial CBC and diff. in the well term baby will likely minimize the number of results with mild elevations of the immature to total neutrophil ratio and optimize the detection of abnormalities [22,23].
In the absence of any laboratory test abnormality in the well at-risk baby, close observation should occur for a minimum of 48 hours and include recording of 4 hourly vital signs including blood pressure. The same caveats discussed above regarding the observational approach (see 2.B.1.) apply to this group of babies. The physician may decide to treat the well baby with a history of untreated maternal chorioamnionitis, despite a normal CBC and diff. When the baby is ready for discharge, it should be ensured that 1) specific family counseling has been given, 2) a discussion of how the family would access emergency care has occurred and 3) the family has the telephone number of their physician for follow-up / the nursery and can contact medical care.
The presence of a white cell count abnormality, especially neutropenia or an increased immature to total neutrophil count above established normal neonatal values [24-27], prompts the drawing of cultures. Although physicians may chose to perform a lumbar puncture, it is viewed as reasonable not to perform a lumbar puncture unless the baby develops signs of sepsis and is stable enough at that time to have a lumbar puncture performed. A chest X-ray is performed if there are signs of respiratory distress. The baby receives antibiotics until clinical and laboratory data satisfy the clinician that infection is absent.
2.B.2.2. Adequate IAP therapy (³ 4 hours prior to delivery).
The maternal amniotic fluid antibiotic concentrations in such patients indicate that the antibiotic has reached the fetus in substantial amounts but a caveat is that ³ 4 hours of therapy may be still be inadequate to prevent neonatal sepsis if a heavy bacterial growth exists [3].
2.B.2.2.1. Adequate IAP therapy (³ 4 hours) AND Maternal Chorioamnionitis.
Well babies born to mothers with chorioamnionitis have a greater risk for neonatal sepsis [5]. Thus, it is recommended that laboratory evaluation (CBC + Diff.) be performed if there are any findings resulting in a diagnosis of maternal chorioamnionitis (e.g. the maternal temperature intrapartum was ³ 38oC) regardless of the adequacy of maternal IAP. In addition, if the mother of a well newborn becomes febrile postpartum and is considered to have a uterine infection with or without adequate IAP, the clinician should consider performing a CBC and diff..
Should a laboratory abnormality be detected, the management of the neonate is as described in 2.B.2.1.. In the absence of any laboratory abnormality, consideration for discharge should not occur until after a minimum of 48 hours of close observation and family instruction is complete - see 2.B.2.1. and 2.B.2.2.2. below. In considering the risk of sepsis for the neonate and the nature of the available facilities and staffing, the physician may decide to perform further laboratory investigations and treat the baby empirically until he/she is satisfied that no infection exists.
2.B.2.2.2. Adequate IAP therapy (³
4 hours) AND No Maternal Chorioamnionitis.
OR GBS Unknown with No Risk Factors.
Close clinical observation is recommended in these well babies as in 2.B.1. Clinicians may decide to perform laboratory evaluations and employ selective treatment on the basis of concerns about employing an observational approach in their particular circumstances or on the basis of increased risk due to prolonged rupture of the membranes alone. If risk factors are present prior to delivery, discharge should be not considered until a minimum of 48 hours of clinical observation which includes recording of 4 hourly vital signs including blood pressure. If no risk factors are present but the GBS status is unknown, then discharge may be considered after a minimum of 24 hours of close observation. When the baby is ready for discharge, it should be ensured that 1) specific family counseling has been given, 2) a discussion of how the family would access emergency care has occurred and 3) the family has the telephone number of their physician for follow-up / the nursery and can contact medical care.
2.C. Conclusions for the Management of the "Well" Neonate at Risk of Sepsis.
· The mother who has had a previous baby with GBS sepsis should receive adequate intrapartum chemoprophylaxis. If such mothers are untreated or inadequately treated (intrapartum antibiotics < 4 hours prior to delivery), then the well newborn should be evaluated until the physician is satisfied that no infection exists.
The well twin (or other sib from multiple pregnancy) of an index case with GBS infection should be considered for empirical therapy.
· Well preterm babies (< 37 weeks), independent of maternal intrapartum antibiotic treatment prior to birth, should be considered for evaluation with laboratory test(s) and treated if indicated. Some authorities view the < 34 week preterm baby at especial risk and would consider empirical therapy. For those with a maternal history of pPROM and/or chorioamnionitis, the physician has to use clinical judgment in selecting an observational/selective therapy approach or one consisting of laboratory investigations and empirical therapy. In the well preterm baby delivered by cesarean section for maternal reasons (i.e. without: 1) preterm labor; 2) premature rupture of the membranes without labor and 3) any other risk factors for sepsis), the physician may elect only to observe the baby closely (vital signs 4 hourly including BP) for a minimum of 48 hours or perform laboratory evaluation followed by ³ 48 hours of close observation or start therapy.
· In well babies ³ 37 weeks, laboratory evaluation and selective treatment is recommended when maternal IAP was inadequate or was adequate but maternal chorioamnionitis was diagnosed (e.g. by the presence of an intrapartum temperature ³ 38oC). Laboratory evaluation and selective treatment should also be considered when maternal uterine infection occurs postpartum. Close postnatal observation should be employed for a minimum of 48 hours. In the presence of chorioamnionitis, especially if IAP was inadequate, the physician may elect to perform laboratory investigations and treat the baby until he/she is satisfied that no infection exists.
· For the well baby ³ 37 weeks, close postnatal observation alone for a minimum of 48 hours is recommended if risk factor(s) were present but the maternal IAP was adequate and maternal chorioamnionitis was not diagnosed. The physician may elect on the basis of a single known risk factor to employ the laboratory evaluation and selective therapy approach. If no risk factors are present but the GBS status is unknown, then discharge may be considered after a minimum of 24 hours of close postnatal observation.
· When the baby is ready for discharge, it should be ensured that 1) specific family counseling has been given, 2) a discussion of how they would access emergency care has occurred and 3) the family has the telephone number of their physician for follow-up / the nursery and can contact medical care.
· Assuming that observation alone and selective laboratory evaluation identify and minimize the effects of sepsis equally, family psychological considerations will not differ.
· The monetary cost difference will be that of laboratory evaluation(s), if both approaches avoid the large costs which accompany intensive care and any subsequent morbidity due to sepsis.
· Multicenter controlled trials or analyses of large multicenter observational databases are needed to determine the optimal management of the baby at risk of neonatal sepsis.
3. The Neonate with Signs of Sepsis.
Approximately 20% of babies who develop perinatally acquired neonatal sepsis are not identified by risk factors before birth and do not always present at birth with signs. These "well" babies can have passed transition and be rooming-in with their mothers without receiving the benefits of increased maternal counseling and nursing observation afforded the "at-risk" well baby. Thus, prior to discharge medical staff need to monitor the health of all babies and alert the family to the potential signs of sepsis, such as hypothermia, hyperthermia, respiratory distress, lethargy, poor perfusion and poor feeding.
Any baby presenting with signs compatible with sepsis should be evaluated clinically. The differential diagnosis for such signs is extensive including transient tachypnea of the newborn, a disseminated viral infection, e.g. herpes simplex virus (HSV) infection, or rarely an inborn error of metabolism. Thus, laboratory studies, including a white cell count and differential, and radiographic studies are performed according to the clinician’s judgment. If possible a blood culture and a lumbar puncture, if the baby is sufficiently stable, are performed prior to commencing antibiotic therapy for sepsis. The baby is then given intravenous antibiotic therapy and fluids (nothing by mouth). He/she should be carefully observed, especially for shock, apnea, an abnormal oxygen saturation and seizures. The antibiotic therapy should be continued until sepsis can be ruled out. Some physicians would consider concurrent acyclovir therapy until HSV infection is ruled out. Transfer to a neonatal intensive care unit may be required.
A white cell count and differential can be normal early in the course of a baby with sepsis and should not be used to decide upon therapy in a baby with signs which the physician interprets as those of sepsis [23,28,29]. On the other hand, serial negative white cell count results can be very useful [6]. By contrast the onset of or a worsening of neutropenia or thrombocytopenia in the face of therapy may indicate the presence of a bacteria or virus not sensitive to the current antibiotic therapy.
Isolation and Prevention of Nosocomial Spread.
The routine enforcement of universal precautions is recommended. Handwashing is mandatory for the care of all neonates and gloves should be worn when there is the risk of or actual handling of any body fluid from a neonate suspected of or with a proven infection. No special precautions are recommended except during a nursery outbreak of GBS disease [4]. In that event, cohorting of ill and colonized neonates and the use of gown and gloves are recommended.
Antibiotic Therapy for Neonates aged 0-6 postnatal days and its Duration.
In term neonates, the initial therapy is ampicillin (100mg/kg/day intravenously, in two divided doses) plus an aminoglycoside (gentamicin, 5 mg/kg/day intravenously, in two divided doses. For proven or suspected meningitis, the dose of ampicillin is increased (200mg/kg/day in three divided doses) [4]. Penicillin G can be used for Group B Streptococcal infection (100,000IU/kg/day as bd doses or with meningitis 250,000 to 400,000 U/kg/day in three divided doses). Dosages are adjusted for preterm babies. Instead of gentamicin, an appropriate third generation cephalosporin can be selected. The antibiotic therapy is adjusted according to the sensitivity of the organism and individualized according to pharmacokinetic needs.
The duration of antibiotic therapy will depend upon the clinical course and the results of the cultures. The following presume that the patient with signs recovers clinically during the course of the therapy. Re-evaluation of therapy is required if signs of sepsis are ongoing. If meningitis is present, antibiotic therapy will be given for ³ 14 days. Longer treatment is advised with osteomyelitis [4]. When infection is diagnosed clinically and this is confirmed by blood culture, then a full course of therapy (10-14 days) is given. If the baby presents with signs diagnosed as infection but the 48-72 hour culture results do not indicate the presence of infection, then some physicians will stop therapy and observe while others will decide to prolong therapy until they are satisfied that no infection exists. In addition, in a baby with signs of infection but negative cultures at 3 days, further evaluation should be considered when the newborn's urine latex particle agglutination test for GBS is positive or if white cell count abnormalities are marked or persistent [19, 25-27]. The interpretation of a negative blood culture result in a baby whose mother has received antibiotics prior to birth is problematic. Delaying the blood culture 6-12 hours in the well baby will reduce the likelihood of a false negative culture result as ampicillin given to the mother attains peak concentration in fetal serum at one hour and remains therapeutic for up to 4 hours [16]. In the baby who never develops signs of sepsis or who has mild signs which disappear within 24 hours, consensus opinion recommends that antibiotic therapy be stopped when the culture(s) are reported as negative at 48-72 hours [19,30,31]. Shorter periods of therapy (24-48 hours) have been used when penicillin was administered postnatally to decrease the incidence of GBS disease in at-risk neonates.
3. Conclusions for the Management of the Neonate with Signs of Sepsis.
· Any neonate judged clinically to have signs of sepsis should receive a full laboratory evaluation and be treated appropriately as above. Discharge criteria are as cited in 2.C..
This practice parameter for early neonatal sepsis presents an approach to early-onset neonatal sepsis (excluding specific perinatal infections) based on the general approach below.
Emphasis is placed upon the clinical evaluation of the neonate taking into consideration the clinical examination, the clinical history of risk factors for the neonate, maternal intrapartum antimicrobial prophylaxis (IAP) and then the result(s) of any laboratory or radiographic evaluation(s) that is / are performed. Early discharge (>24 hours < 48 hours) is excluded for neonates at-risk of sepsis and when discharge is considered full preparation of the family should be ensured.
The following algorithm should be used in conjunction with the text. It presents one approach to the evaluation and initial management of the neonate with signs compatible with sepsis or at-risk of sepsis. Note that the cornerstone is the clinical history and examination of the neonate. While laboratory test(s) can assist clinical evaluation, the determinant of the course of management is clinical judgment.
EVALUATION of NEONATE with SIGNS of SEPSIS or AT-RISK of SEPSIS.
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