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

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
acidosis^8,10,,36 and meconium staining.³⁷ The efficacy of intrapartum antibiotics in these
settings has not been quantified.

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

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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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
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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.