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Infection (Systemic Late Onset) on the Neonatal Unit
Clinical Guideline
V2.0
July 2020
Infection (Systemic Late Onset) on the Neonatal Unit Clinical Guideline V2.0 Page 2 of 12
1. Aim/Purpose of this Guideline
1.1. This guideline applies to all staff working in the Women and Children’s Care Group with an aim to provide evidence based guidance in the Investigation and Management of Late Onset Sepsis (LOS) on the Neonatal Unit. This guideline covers the diagnosis and management of systemic (blood stream and/or meningitis) infection in neonates on NNU who have not previously been discharged from hospital.
1.2. This version supersedes any previous versions of this document.
2. The Guidance
Scope: This guideline covers the diagnosis and management of systemic (blood stream and/or meningitis) infection in neonates on NNU who have not previously been discharged from hospital.
2.1. Features that may indicate sepsis
Temperature instability or >37.5oC or 36.5oC Tachypnoea / Apnoeas / Respiratory distress Tachycardia / Bradycardia Neurological features: Lethargy, poor tone, poor feeding, irritability, seizures Other features: Jaundice, hepatomegaly, vomiting, abdominal distension, diarrhoea
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2.2. Initial investigations
Investigation Further information
In all cases :
Blood culture May identify bacteria and fungal infection
Full blood count Looking at neutrophils and platelets
CRP NICE guideline on EOS suggests levels of >10 are abnormal.
Blood gas Acidosis/ lactic acid level
To consider based on clinical context :
Urine culture Aim to perform a urine culture on all babies with sepsis >72h old
Clean catch/ SPA/ catheter sample
Other cultures From any potential foci of infection e.g.
- purulent eye drainage
- pustules
- tracheal aspirate – send on all ventilated babies with LOS
Lumbar puncture Consider in all cases of suspected LOS if no contraindications and if
baby able to tolerate the procedure.
Clinical signs suggesting meningitis can be lacking in neonates.
Giving antibiotics before performing LP underestimates meningitis
2.3. Initial management
Commence empiric antimicrobial therapy. Administer within 60 minutes of decision to treat.
Diagnosis Empiric therapy
Late onset sepsis, meningitis
not immediately suspected
Flucloxacillin + Gentamicin
Always consider risk of HSV and
add aciclovir if appropriate
Suspected neonatal meningitis Amoxicillin + Cefotaxime
Ensure the infant is in an environment allowing close monitoring. Inform a middle grade doctor or consultant.
Have a low threshold for removal of indwelling lines. If lines are left in at this point:
The baby needs daily blood cultures until they are recovered or the line is removed
Consider removing the line if the baby is still unwell 24 hours or
more after initial suspicion of LOS
Infection (Systemic Late Onset) on the Neonatal Unit Clinical Guideline V2.0 Page 4 of 12
2.4. Ongoing management
2.4.1. Repeat CRP 18-24 hours after initial suspected LOS presentation. 2.4.2. Usually continue antibiotics, once started, until 36 hour blood culture
result.
2.4.3. If 36 hour blood culture is negative, decision to continue or cease antibiotics is senior-led.
2.4.4. If meningitis clinically suspected but CSF microscopy is normal, continue meningitis Treatment until CSF cultures negative.
2.4.5. If CSF is culture positive, consider repeat LP after 2 days.
2.4.6. Usually start anti-fungal therapy (oral miconazole and
topical clotrimazole) if antibiotics continue for longer than 36-48 hours. These antifungals should continue for 2 days after the antibiotics stop.
2.4.7. If blood culture is positive :
2.4.7.1. In all cases :
Consider removing an indwelling lines that were not
removed at first suspicion of LOS
Complete a Datix, as all healthcare associated bacteraemias must be Datixed
Inform neonatal research nurse for uploading to Neonin database
2.4.7.2. If a CoNS (coagulase negative staphylococcus) is grown on blood culture : Stop flucloxacillin and gentamicin and start vancomycin
2.4.7.3. If an as yet undetermined Staphylococcus species is grown on blood culture AND the baby has a central/long line AND the baby is not clearly responding to flucloxacillin and gentamicin :
Switch to vancomycin
Consider need for continuing Gram negative cover : remember increased toxicity risk with vancomycin and gentamicin in combination
Discuss with Clinical Microbiology
Infection (Systemic Late Onset) on the Neonatal Unit Clinical Guideline V2.0 Page 5 of 12
2.4.7.4. If Gram-negative organism grown on blood culture, add another antibiotic active against gram-negatives (eg Cefotaxime) and stop benzylpenicillin. Seek microbiological advice based on organism and sensitivities.
2.4.7.5. If suspected meningitis based on CSF microscopy, pending culture result, treat with Cefotaxime and Amoxicillin.
2.4.8. Duration of therapy :
If antibiotics are continued, they should be reviewed daily. Below is a guide to duration of therapy by diagnosis:
Details of infection Proposed minimum
duration of therapy
Suspected sepsis despite negative cultures with
rapid clinical recovery following antibiotics
See above for recommended antibiotic choices.
5 days
Sepsis with positive blood cultures in the absence
of meningitis
See above for recommended antibiotic choices.
7 days
Group B streptococcus meningitis Benzylpenicillin at least 2 weeks & gentamicin for at least the first 5 days
2 weeks
Listeria meningitis: Amoxicillin for at least 3 weeks and add Gentamicin for at least the first 7 days
3 weeks
Gram positive meningitis other than GBS or Listeria Continue Cefotaxime and Amoxicillin whilst seeking clinical microbiologist advice on appropriate targeted antibiotic choice.
Seek senior Clinical Microbiologist advice.
Gram negative (including E.coli) meningitis: Stop amoxicillin and give at least 3 weeks Cefotaxime unless directed otherwise by culture sensitivities.
3 weeks
Gram stain and culture negative meningitis: Cefotaxime and amoxicillin for at least 2 weeks. Consider extending duration of treatment if complicated course, and seek advice.
2 weeks
Infection (Systemic Late Onset) on the Neonatal Unit Clinical Guideline V2.0 Page 6 of 12
2.5. Further information on Late Onset Neonatal Sepsis
2.5.1. Independent risk factors for development of LOS
Low birth weight
Prematurity
Mechanical ventilation
Intravascular catheterisation
Prolonged parenteral nutrition
Hospitalisation
Surgery
Underlying respiratory and cardiovascular disease
Black ethnicity
2.5.2. Rationale for antibiotic choice
Extensive use of broad-spectrum antibiotics is associated with increased rates of colonisation and infection with multi-resistant organisms.1
A large Australian prospective longitudinal study of late onset CoNS infections 1991- 2000 found that mortality from CoNS sepsis was no different between units that used vancomycin as first line treatment and those that used ampicillin or flucloxacillin in combination with an aminoglycoside. 2
Flucloxacillin with gentamicin in combination provides as good empirical cover as cefotaxime monotherapy.3
The BNFC recommends either flucloxacillin with gentamicin or cefotaxime with amoxicillin as suitable alternative empirical regimes for LOS.4
Most organisms in LOS are susceptible to gentamicin with flucloxacillin or amoxicillin.5
2.5.3. Adjunctive therapy
Pooled intravenous immunoglobulin is not effective as an adjunct to antibiotic therapy in neonatal infection and should not be used. There is currently insufficient evidence to support use of other adjunctive therapies in neonatal sepsis.
Infection (Systemic Late Onset) on the Neonatal Unit Clinical Guideline V2.0 Page 7 of 12
2.5.4. Prevention of LOS
Regarding intravenous catheters
Strict aseptic non-touch technique for all invasive
procedures ALL clinical staff on NNU must undertake an annual
assessment of their ANTT practice Fastidious line care and monitoring (documented on line
care sheet) Avoidance of the femoral route where possible Prompt removal of unnecessary catheters
Hand hygiene
MRSA screening for all admissions as per policy
Use of enteral nutrition guideline to avoid unnecessary time on TPN
Optimisation of measures to prevent/ minimise need for invasive NNU treatments (eg antenatal steroids, appropriate use of non-invasive resp support).
2.5.5. Fungal sepsis
Risk factors
VLBW or ELBW
Parenteral nutrition
Intravascular catheters
Gut sepsis
Broad spectrum antibiotic use
Evidence of tracheal Candida colonisation 7.
2.6. Prophylaxis
Recommended for infants continuing antibiotics beyond 36-48 hours.
* Limited evidence. At present this is not part of routine practice in the UK.
2.7. Clinical features
25-50% mortality risk
Features as bacterial sepsis
Consider especially in infants who have not responded to antibiotics
Infection (Systemic Late Onset) on the Neonatal Unit Clinical Guideline V2.0 Page 8 of 12
2.8. Investigations
As above, also urine culture and microscopy for budding yeast and
hyphae, request renal ultrasound scan, and arrange retinal examination
2.9. Treatment
Amphotericin B remains the standard of care for neonatal candidiasis.
Consider adding Flucytosine if CNS infection with Candida species.
Evidence for choice and duration of therapy is limited
Consultant decision in liaison with microbiology
See https://drfungus.org/knowledge-base/neonatal-candidiasis/ for an extensive review of epidemiology, risk factors, microbiology and treatment of neonatal candidiasis.
3. Monitoring compliance and effectiveness
Element to be monitored
Antibiotic choice and course length
Lead Audit and guidelines lead
Tool Ad hoc review of cases on a WORD or Excel template
Frequency annual
Reporting arrangements
Neonatal Guidelines Meeting
Acting on recommendations and Lead(s)
Neonatal Business Meeting
Change in practice and lessons to be shared
Required changes to practice will be identified and actioned within 3 months. A lead member of the team will be identified to take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders
4. Equality and Diversity
4.1. This document complies with the Royal Cornwall Hospitals NHS Trust
service Equality and Diversity statement which can be found in the 'Equality, Inclusion & Human Rights Policy' or the Equality and Diversity website.
4.2. Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2.
Infection (Systemic Late Onset) on the Neonatal Unit Clinical Guideline V2.0 Page 9 of 12
Appendix 1. Governance Information
Document Title Infection (Systemic Late Onset) on the Neonatal Unit Clinical Guideline V2.0
This document replaces (exact title of previous version):
Late Onset Sepsis (Los) on the Neonatal Unit Clinical Guideline V1.0
Date Issued/Approved: June 2020
Date Valid From: July 2020
Date Valid To: July 2023
Directorate / Department responsible (author/owner):
Dr Andrew Collinson, Consultant in Neonatology and Paediatrics
Contact details: 01872 262667
Brief summary of contents Guidance for diagnosis and management of late onset infection in neonates on neonatal unit.
Suggested Keywords: Sepsis, Late Onset Sepsis, Neonatal, neonatal sepsis, Neonatology
Target Audience RCHT CFT KCCG
Executive Director responsible for Policy:
Medical Director
Approval route for consultation and ratification:
Neonatal Guidelines Group
General Manager confirming approval processes
Mary Baulch
Name of Governance Lead confirming approval by specialty and care group management meetings
Caroline Amukusana
Links to key external standards
https://www.medicinescomplete.com/mc/bnf c/current/PHP78491-blood-infections- bacterial.htm?q=sepsis&t=advanced&ss=ts& tot=8&p=2#_hit 5Dong et al, Archives Fetal Neonatal 2015: 100:F257-F263 (open access, see https://www.ncbi.nlm.nih.gov/pmc/articles/P MC4413803/pdf/fetalneonatal-2014- 306213.pdf)
Related Documents:
1 Isaacs D, Arch Dis Child Fetal Neonatal Ed 2006;91:F72–F74
2 D Isaacs Arch Dis Child Fetal Neonatal Ed 2003;88:F89–F93 and Karlowicz M, et al, Pediatrics 2000; 106:1387-1390
3 Muller-Pebody et al 2011 Jan;96(1):F4-8
4 See
Infection (Systemic Late Onset) on the Neonatal Unit Clinical Guideline V2.0 Page 10 of 12
https://www.medicinescomplete.com/mc/bnf c/current/PHP78491-blood-infections- bacterial.htm?q=sepsis&t=advanced&ss=ts &tot=8&p=2#_hit 5 Dong et al, Archives Fetal Neonatal 2015: 100:F257-F263 (open access, see https://www.ncbi.nlm.nih.gov/pmc/articles/P MC4413803/pdf/fetalneonatal-2014- 306213.pdf) 6 Roen J et al, 1994.
Training Need Identified? No
Publication Location (refer to Policy on Policies – Approvals and Ratification):
Internet & Intranet Intranet Only
Document Library Folder/Sub Folder
Clinical / Neonatal
Version Control Table
Date Version
No Summary of Changes
Changes Made by (Name and Job
Title)
14 Jun 17 V1.0
Paul Munyard Neonatal Consultant
June 2020 V2.0
Title amended. Scope section added for clarity. Details of antibiotic choices and duration expanded and edited to ensure consistent with NICE guidance. Evidence sources and references checked and updated. Removal of the section on further updates.
Andrew Collinson
All or part of this document can be released under the Freedom of Information
Act 2000
This document is to be retained for 10 years from the date of expiry.
This document is only valid on the day of printing
Controlled Document
This document has been created following the Royal Cornwall Hospitals NHS Trust
Policy for the Development and Management of Knowledge, Procedural and Web
Documents (The Policy on Policies). It should not be altered in any way without the
express permission of the author or their Line Manager.
Infection (Systemic Late Onset) on the Neonatal Unit Clinical Guideline V2.0 Page 11 of 12
Appendix 2. Equality Impact Assessment
Section 1: Equality Impact Assessment Form
Name of the strategy / policy /proposal / service function to be assessed Infection (Systemic Late Onset) on the Neonatal Unit Clinical Guideline V2.0
Directorate and service area: Neonatal
Is this a new or existing Policy? Existing
Name of individual/group completing EIA Neonatal guidelines group
Contact details: 01872 252667
1. Policy Aim Who is the strategy / policy / proposal / service function aimed at?
To provide guidance for diagnosis and management of late onset infection in neonates on neonatal unit.
2. Policy Objectives As above
3. Policy Intended Outcomes
As above
4. How will you measure the outcome?
See section 3
5. Who is intended to benefit from the policy?
All Neonatal patients
6a). Who did you consult with?
b). Please list any groups who have been consulted about this procedure.
Workforce Patients Local groups
External organisations
Other
x
Please record specific names of groups:
Neonatal Guidelines Group
c). What was the outcome of the consultation?
Document approved
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7. The Impact Please complete the following table. If you are unsure/don’t know if there is a negative impact you need to repeat the consultation step. Are there concerns that the policy could have a positive/negative impact on:
Protected Characteristic
Yes No Unsure Rationale for Assessment / Existing Evidence
Age X
Sex (male, female non-binary, asexual etc.)
X
Gender reassignment X
Race/ethnic communities /groups X
Any information provided should be in an accessible format for the parent/carer’s needs – i.e. available in different languages if required/access to an interpreter if required
Disability (learning disability, physical disability, sensory impairment, mental health problems and some long term health conditions)
X
Those parent/carers with any identified additional needs will be referred for additional support as appropriate - i.e to the Liaison team or for specialised equipment. Written information will be provided in a format to meet the family’s needs e.g. easy read, audio etc
Religion/ other beliefs X
All staff should be aware of any beliefs that may impact on the decision to treat
Marriage and civil partnership X
Pregnancy and maternity X
Sexual orientation (bisexual, gay,
heterosexual, lesbian) X
If all characteristics are ticked ‘no’, and this is not a major working or service change, you can end the assessment here as long as you have a robust rationale in place.
I am confident that section 2 of this EIA does not need completing as there are no highlighted risks of negative impact occurring because of this policy.
Name of person confirming result of initial impact assessment:
Neonatal guidelines group
If you have ticked ‘yes’ to any characteristic above OR this is a major working or service change, you will need to complete section 2 of the EIA form available here: Section 2. Full Equality Analysis For guidance please refer to the Equality Impact Assessments Policy (available from the document library) or contact the Human Rights, Equality and Inclusion Lead [email protected]
