Neonatal sepsis (patient information)
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Neonatal sepsis |
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Neonatal sepsis On the Web |
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Editor-in-Chief: C. Michael Gibson, M.S.,M.D. [1] Phone:617-632-7753; Associate Editor(s)-In-Chief: Lakshmi Gopalakrishnan, M.B.B.S. Jason Le, B.S.[2]
Synonyms and Keywords: Sepsis neonatorum; Neonatal septicemia
Sepsis patient information (Neonatal)
Overview
Neonatal sepsis is a clinical syndrome caused by bacteremia or invasive bacterial infection during the first 90 days of life. It is conventionally divided into early-onset sepsis (EOS), occurring within the first 72 hours of life, and late-onset sepsis (LOS), occurring after 72 hours through 90 days. Definitions of EOS vary among studies and guidelines, with some using the first 7 days of life. EOS is usually associated with vertical transmission around delivery, whereas LOS is more often acquired postnatally or in healthcare settings.[1][2]
Neonatal sepsis can progress rapidly and requires prompt clinical assessment. Management depends on gestational age, clinical appearance, timing of onset, maternal and perinatal risk factors, microbiologic findings, and whether infection was acquired in the community or healthcare setting.
What are the symptoms of Neonatal sepsis?
Signs of neonatal sepsis may be nonspecific and can include:
- Temperature instability
- Breathing difficulty, apnea, grunting, or increased work of breathing
- Reduced sucking or feeding intolerance
- Reduced activity or movement
- Vomiting
- Abdominal distention
- Abnormal heart rate
- Low blood glucose
- Jaundice
- Seizures
- Other signs of clinical deterioration or shock
A newborn with possible sepsis may not have fever. Any infant with concerning clinical deterioration should receive urgent medical evaluation.
What causes Neonatal sepsis?
Neonatal sepsis can be caused by a range of bacterial pathogens. In EOS, group B streptococcus (GBS) and Escherichia coli are important pathogens. The empiric EOS regimen of ampicillin plus gentamicin is designed to cover the principal early-onset pathogens, including GBS, other streptococci, enterococci, and Listeria monocytogenes.[1]
Risk factors
Risk factors vary according to the timing and setting of infection.
- Risk factors for early-onset sepsis include:
- Maternal GBS colonization or infection
- Preterm birth
- Prolonged rupture of membranes
- Intra-amniotic infection or maternal infection around delivery
- Other maternal or intrapartum factors incorporated into validated EOS risk-assessment approaches
- Risk factors for late-onset sepsis include:
- Prematurity and prolonged hospitalization
- Central venous or other indwelling vascular catheters
- Healthcare exposure
- Prior antimicrobial exposure
- Other invasive procedures or devices
When to seek urgent medical care?
Seek immediate medical attention for a newborn or young infant with possible sepsis, particularly with breathing difficulty, apnea, poor feeding, markedly reduced activity, seizures, temperature instability, or other signs of clinical deterioration.
Diagnosis
Diagnosis is based on the clinical presentation together with microbiologic and laboratory evaluation. No single laboratory test reliably establishes or excludes neonatal sepsis.
Early-onset sepsis risk assessment
For infants born at approximately 34 weeks' gestation or later, a validated multivariate tool, the Kaiser Permanente Neonatal Early-Onset Sepsis Risk Calculator, combines gestational age, highest maternal intrapartum temperature, maternal GBS status, duration of rupture of membranes, and intrapartum antibiotic type and timing with serial clinical examination to guide observation, testing, or empiric antibiotic treatment.[1][3][4]
The EOS calculator is intended for risk stratification and should be interpreted together with serial clinical examinations rather than treated as a precise measurement of an individual infant's absolute probability of infection. Implementation studies have shown substantial reductions in blood-culture testing and empiric antibiotic exposure without evidence of increased adverse outcomes.[1][4]
Antibiotic treatment should not be based solely on an isolated laboratory abnormality in an otherwise well-appearing infant.
Laboratory evaluation
- Blood culture is the key microbiologic test for suspected bacterial sepsis.
- Additional laboratory studies may include a complete blood count, glucose, blood gas, and inflammatory markers when clinically indicated. Complete blood count and C-reactive protein do not perform well as standalone tests for predicting early-onset infection, particularly in well-appearing low-risk infants, and abnormal results alone should not be used to justify prolonged antibiotic treatment.[5]
- When EOS is confirmed by a positive blood culture, a lumbar puncture should be performed if not already done, provided the infant is clinically stable enough for the procedure, because bacteremia and meningitis may not always occur together.[1]
- Urine testing is particularly relevant in older infants with community-acquired late-onset infection.
- Additional testing or imaging should be directed by the clinical presentation and suspected site of infection.
For well-appearing febrile infants 8 to 60 days old, the AAP febrile-infant guideline provides age-specific evaluation and management pathways and should be used rather than extrapolating neonatal EOS algorithms to this population.[6]
Treatment options
Suspected neonatal sepsis generally requires prompt hospital-based assessment and, when indicated, empiric antimicrobial therapy before the causative organism is known.
Empiric antimicrobial therapy
For early-onset sepsis, ampicillin plus gentamicin is the first-choice empiric regimen. This combination covers GBS, other streptococci, enterococci, and Listeria monocytogenes; most ampicillin-resistant E. coli isolates remain susceptible to gentamicin. Routine broader-spectrum therapy is not warranted and may be harmful; broader coverage should be reserved for critically ill infants or those at highest risk of resistant Gram-negative infection and guided by local resistance patterns.[1]
For late-onset sepsis in hospitalized infants (particularly preterm infants with central venous catheters), empiric therapy typically combines an antistaphylococcal agent, such as flucloxacillin, with an aminoglycoside; vancomycin is substituted when methicillin-resistant or coagulase-negative staphylococci are important concerns, and the empiric choice should include an agent to which GBS remains susceptible. Empiric selection should reflect local epidemiology, healthcare exposure, indwelling devices, prior antimicrobial exposure, and resistance patterns.[2]
For previously healthy infants presenting from the community with late-onset infection, recommended empiric therapy differs: ampicillin plus ceftazidime for infants 8 to 28 days of age and ceftriaxone for infants 29 to 90 days of age, with vancomycin added when there is meningitis or critical illness.[5]
Ceftriaxone is contraindicated in neonates (≤28 days of age): it can displace bilirubin from albumin, posing a risk of bilirubin encephalopathy (particularly in premature or hyperbilirubinemic infants), and may form fatal precipitates with calcium-containing intravenous solutions. This is the basis for using ampicillin plus ceftazidime, rather than ceftriaxone, in infants 8 to 28 days of age; cefotaxime is an alternative where ceftriaxone is otherwise indicated but cannot be used.[7][8]
Exact neonatal doses and dosing intervals vary with gestational age, postnatal age, weight, renal function, and local protocol and should follow current neonatal antimicrobial references and institutional guidance.
When a blood culture confirms EOS, a lumbar puncture should be performed if not already done. When initial blood cultures remain sterile at 36 to 48 hours of incubation, empiric antibiotics should generally be discontinued unless there is evidence of site-specific infection. Continuing empiric therapy in response to laboratory abnormalities alone is rarely justified, particularly in well-appearing infants.[1][9]
Antibiotics should be narrowed or discontinued when the clinical and microbiologic evaluation no longer supports bacterial infection, when appropriate.
When group B streptococcus is identified, penicillin G is the preferred definitive agent (ampicillin acceptable). Typical treatment duration is 10 days for bacteremia without a focus and 14 days for uncomplicated meningitis, with longer courses for complicated, osteoarticular, or ventricular infection.[5]
Prevention
Prevention of neonatal sepsis includes prevention and treatment of maternal infection, appropriate GBS screening and intrapartum prophylaxis, and infection-prevention practices during delivery and neonatal care.
Universal antenatal GBS screening by vaginal-rectal culture is recommended at 36 0/7 to 37 6/7 weeks' gestation, with intrapartum antibiotic prophylaxis given to colonized pregnant persons and to others meeting established risk criteria.[5][10]
Penicillin G is the preferred GBS intrapartum prophylactic agent and ampicillin is an acceptable alternative. For penicillin allergy, cefazolin is used for low-risk allergy; clindamycin is used for high-risk allergy only when the GBS isolate is documented to be susceptible; and vancomycin is used for high-risk allergy when clindamycin cannot be used because of resistance or unknown susceptibility.[10][11]
For the purpose of newborn risk assessment, adequate intrapartum prophylaxis is defined as at least one dose of penicillin G, ampicillin, or cefazolin administered 4 or more hours before delivery; clindamycin and vancomycin are not counted as adequate intrapartum prophylaxis for this purpose. The Neonatal Early-Onset Sepsis Risk Calculator uses a 2-hour threshold for GBS-specific antibiotics.[10]
Antenatal penicillin allergy testing is encouraged when appropriate because many reported penicillin allergies are not true IgE-mediated hypersensitivity. Confirming beta-lactam tolerance can allow use of preferred beta-lactam prophylaxis. Clindamycin and vancomycin are less effective than beta-lactam agents at preventing early-onset GBS disease.[11]
When vancomycin is required for GBS intrapartum prophylaxis, the validated weight-based regimen is 20 mg/kg intravenously every 8 hours, with a maximum of 2 g per dose.[11]
Clean delivery practices, appropriate hand hygiene, careful management of vascular catheters and other invasive devices, and prompt recognition and treatment of maternal and neonatal infection are important components of prevention.
What to expect (Outlook/Prognosis)?
Outcome depends on the infant's gestational and postnatal age, severity and site of infection, causative organism, and speed of recognition and treatment. Prompt appropriate treatment improves the likelihood of recovery. Severe neonatal sepsis can result in neurologic injury, other organ dysfunction, or death.
Possible complications
Potential complications include:
- Meningitis
- Neurologic injury
- Organ dysfunction
- Shock
- Death
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 Puopolo KM, Benitz WE, Zaoutis TE, COMMITTEE ON FETUS AND NEWBORN, COMMITTEE ON INFECTIOUS DISEASES (2018). "Management of Neonates Born at ≥35 0/7 Weeks' Gestation With Suspected or Proven Early-Onset Bacterial Sepsis". Pediatrics. 142 (6): e20182894. doi:10.1542/peds.2018-2894.
- ↑ 2.0 2.1 Strunk T, Molloy EJ, Mishra A, Bhutta ZA (2024). "Neonatal Bacterial Sepsis". Lancet. 404 (10449): 277–293. doi:10.1016/S0140-6736(24)00495-1.
- ↑ Espinosa K, Brown SR (2021). "Neonatal Early-Onset Sepsis Calculator". American Family Physician. 104 (6): 636–637.
- ↑ 4.0 4.1 Benitz WE, Achten NB (2021). "Technical Assessment of the Neonatal Early-Onset Sepsis Risk Calculator". The Lancet Infectious Diseases. 21 (5): e134–e140. doi:10.1016/S1473-3099(20)30490-4.
- ↑ 5.0 5.1 5.2 5.3 Invalid
<ref>tag; no text was provided for refs namedAAPGBS2019 - ↑ Pantell RH, Roberts KB, Adams WG; et al. (2021). "Evaluation and Management of Well-Appearing Febrile Infants 8 to 60 Days Old". Pediatrics. 148 (2): e2021052228. doi:10.1542/peds.2021-052228.
- ↑ US Food and Drug Administration. "Ceftriaxone for injection, USP — Prescribing Information (Contraindications: Neonates)". DailyMed, US National Library of Medicine.
- ↑ Workowski KA, Bachmann LH, Chan PA; et al. (2021). "Sexually Transmitted Infections Treatment Guidelines, 2021". MMWR Recommendations and Reports. 70 (4): 1–187. doi:10.15585/mmwr.rr7004a1.
- ↑ Puopolo KM, Benitz WE, Zaoutis TE, COMMITTEE ON FETUS AND NEWBORN, COMMITTEE ON INFECTIOUS DISEASES (2018). "Management of Neonates Born at ≤34 6/7 Weeks' Gestation With Suspected or Proven Early-Onset Bacterial Sepsis". Pediatrics. 142 (6): e20182896. doi:10.1542/peds.2018-2896.
- ↑ 10.0 10.1 10.2 Committee on Infectious Diseases, American Academy of Pediatrics (2024). "Group B Streptococcal Infections". Red Book: 2024-2027 Report of the Committee on Infectious Diseases. American Academy of Pediatrics.
- ↑ 11.0 11.1 11.2 Committee on Obstetric Practice (2020). "Prevention of Group B Streptococcal Early-Onset Disease in Newborns: ACOG Committee Opinion, Number 797". Obstetrics and Gynecology. 135 (2): e51–e72. doi:10.1097/AOG.0000000000003668.