LATE ONSET SEPSIS (LOS) ON THE NEONATAL UNIT - … · LATE ONSET SEPSIS (LOS) ON THE NEONATAL UNIT...

Clinical Guideline Template

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LATE ONSET SEPSIS (LOS) ON THE NEONATAL UNIT

- CLINICAL GUIDELINE


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1. Aim/Purpose of this Guideline All clinical staff working in the Division of women, children & sexual health to provide evidence based guidance in the Investigation and Management of Late Onset Sepsis on the Neonatal Unit

2. The Guidance

Investigation and Management of Late Onset Sepsis on the Neonatal Unit Defined as sepsis diagnosed at >72 hours of age. 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,

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


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incidence by 50% in VLBW infants

Chest x-ray If respiratory symptoms are present

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 acyclovir 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

Ongoing management

Repeat CRP 18-24 hours after initial suspected LOS presentation.

Usually continue antibiotics, once started, until 36 hour blood culture result.

If 36 hour blood culture is negative, decision to continue or cease antibiotics is senior-led.

Note : antibiotics do not need to be continued in this situation, even if CRP or neutrophils raised, if an

alternative diagnosis to LOS is strongly suspected.6

If meningitis clinically suspected but CSF microscopy is normal, continue meningitis Treatment until CSF cultures negative. If CSF is culture positive, consider repeat LP after 2 days. 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.

If blood culture is positive : 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


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Inform neonatal research nurse for uploading to Neonin database

If a CoNS (coagulase negative staphylococcus) is grown on blood culture :

Switch to vancomycin and stop gentamicin

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

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

5 days

Sepsis with positive blood cultures in the absence

of meningitis

7 days

Gram positive meningitis - Group B streptococcus Benzylpenicillin 2 weeks & 5 days gentamicin Listeria – 3 weeks amoxicillin & 7 day s gentamicin

excludes Enterococcus

2 – 3 weeks

Gram negative (including E.coli) and Enterococcus

meningitis

3 weeks

Further information on Late Onset Neonatal Sepsis Epidemiology of LOS

A study of RCHT microbiology data of neonatal admissions from July 2014 to June 2015

demonstrated 3.2% of all RCHT neonatal unit admissions suffered LOS.

Independent risk factors for development of LOS


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Low birth weight

Prematurity

Mechanical ventilation

Intravascular catheterisation

Prolonged parenteral nutrition

Hospitalisation

Surgery

Underlying respiratory and cardiovascular disease

Black ethnicity

Rationale for antibiotic choice

Broad-spectrum antibiotics promote colonisation and resistance and increases neonatal mortality.1

Flucloxacillin has been shown to be as effective as vancomycin in initial therapy for late-onset sepsis (hence vancomycin not started empirically).2

Flucloxacillin with gentamicin in combination provides at least 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

Adjunctive therapy

There is currently insufficient evidence to support use of IVIg or G-CSF as adjuvant therapy to antimicrobials in neonatal sepsis.

Prevention of LOS

Regarding intravenous catheters

o Strict aseptic non-touch technique for all invasive procedures o ALL clinical staff on NNU must undertake an annual assessment of their ANTT practice o Fastidious line care and monitoring (documentated on line care sheet) o Avoidance of the femoral route where possible o 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).

Fungal sepsis Risk factors

VLBW or ELBW

Parenteral nutrition

Intravascular catheters

Gut sepsis

Broad spectrum antibiotic use

Evidence of tracheal Candida colonisation 7.


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Prophylaxis

Recommended for infants continuing antibiotics beyond 36-48 hours.

Limited evidence. At present this is not part of routine practice in the UK.

Clinical features

25-50% mortality risk

Features as bacterial sepsis

Consider especially in infants who have not responded to antibiotics

Investigations

As above, also urine culture and microscopy for budding yeast and hyphae, request renal ultrasound

scan, and arrange retinal examination

Treatment

Amphotericin B alone or in combination with 5-fluorocytosine remains the standard of care for

neonatal candidiasis.

Evidence for choice and duration of therapy is limited

Consultant decision in liaison with microbiology

See http://www.doctorfungus.org/mycoses/human/candida/neonatal.htm for an extensive review on investigation and treatment of neonatal candidiasis.

Further updates to this guideline

Any update to this guideline should include: Results of the PREVAIL trial (PREVenting infection using Antimicrobial Impregnated Long lines)

which is due to be completed on 31/08/2017.

Any new data released by NeonIN on demographics of neonatal infections (most recent published data is from 2006-2008).

Any new research on other potential preventative measures such as probiotics, prebiotics, lactoferrin and early enteral trophic feed with breast milk

Any updates on the efficacy of IVIg or G-CSF as adjuvant therapy to antimicrobials.

References 1 Isaacs D, 2000 2 (Karlowicz M, et al, 2000) 3 [NeonIN at ESPID 2016] 4 See https://www.medicinescomplete.com/mc/bnfc/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/PMC4413803/pdf/fetalneonatal-2014-306213.pdf) 6 A 2015 American ‘consensus’ paper stated that ‘isolated abnormal hematological or acute-phase-reactant measurements should not justify continuation of empiric antibiotics for more than 48 hours in well-appearing infants with negative culture results.’ 7. Roen J et al, 1994.

http://www.doctorfungus.org/mycoses/human/candida/neonatal.htm

https://www.medicinescomplete.com/mc/bnfc/current/PHP78491-blood-infections-bacterial.htm?q=sepsis&t=advanced&ss=ts&tot=8&p=2#_hit


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4413803/pdf/fetalneonatal-2014-306213.pdf



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3. Monitoring compliance and effectiveness

Element to be monitored

Ad hoc review of cases

Lead Dr Paul Munyard, Consultant

Tool Ad hoc review of cases

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, Diversity & 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.

http://www.rcht.nhs.uk/GET/d10268876

http://www.rcht.nhs.uk/GET/d10268876

http://www.rcht.nhs.uk/RoyalCornwallHospitalsTrust/OurOrganisation/EqualityAndDiversity/HumanRightsEqualityAndInclusion.aspx


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Appendix 1. Governance Information

Document Title LATE ONSET SEPSIS (LOS) ON THE NEONATAL UNIT - CLINICAL GUIDELINE

Date Issued/Approved: 14/06/2017

Date Valid From: 01/08/2017

Date Valid To: 01/08/2020

Directorate / Department responsible (author/owner):

Paul Munyard Consultant Neonatology

Contact details: 01872 253293

Brief summary of contents

All clinical staff working in the Division of women, children & sexual health to provide evidence based guidance in the Investigation and Management of Late Onset Sepsis on the Neonatal Unit

Suggested Keywords: Sepsis, Late Onset Sepsis, Neonatal, neonatal sepsis, Neonatology

Target Audience RCHT PCH CFT KCCG

Executive Director responsible for Policy:

Medical Director

Date revised: 14/ Jun/2017

This document replaces (exact title of previous version):

LATE ONSET SEPSIS (LOS) ON THE NEONATAL UNIT - CLINICAL GUIDELINE

Approval route (names of committees)/consultation:

Divisional Manager confirming approval processes

Mr David Smith

Name and Post Title of additional signatories

Not Required

Signature of Executive Director giving approval

{Original Copy Signed}

Publication Location (refer to Policy on Policies – Approvals and Ratification):

Internet & Intranet Intranet Only

Document Library Folder/Sub Folder

Links to key external standards See


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https://www.medicinescomplete.com/mc/bnfc/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/PMC4413803/pdf/fetalneonatal-2014-306213.pdf)

Related Documents:

1 Isaacs D, 2000 2 (Karlowicz M, et al, 2000) 3 [NeonIN at ESPID 2016] 4 See https://www.medicinescomplete.com/mc/bnfc/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/PMC4413803/pdf/fetalneonatal-2014-306213.pdf) 6 A 2015 American ‘consensus’ paper stated that ‘isolated abnormal hematological or acute-phase-reactant measurements should not justify continuation of empiric antibiotics for more than 48 hours in well-appearing infants with negative culture results.’ 7. Roen J et al, 1994.

Training Need Identified? No

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
















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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 on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager.


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Appendix 2. Initial Equality Impact Assessment Form

Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Rationale for Assessment / Existing Evidence

Age X

Name of Name of the strategy / policy /proposal / service function to be assessed (hereafter referred to as policy) (Provide brief description): INVESTIGATION AND MANAGEMENT OF LATE ONSET SEPSIS ON THE NEONATAL UNIT

Directorate and service area: Neonatal

Is this a new or existing Policy? New

Name of individual completing assessment: Mr Paul Munyard

Telephone: 01872 253293

1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at?

All clinical staff working in the Division of women, children & sexual health to provide evidence based guidance in the Investigation and Management of Late Onset Sepsis on the 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) Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? b) If yes, have these *groups been consulted? C). Please list any groups who have been consulted about this procedure.

No

7. The Impact Please complete the following table.


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Sex (male, female, trans-

gender / gender reassignment)

X

Race / Ethnic communities /groups

X

Disability - learning disability, physical disability, sensory impairment and mental health problems

X

Religion / other beliefs

X

Marriage and civil partnership

X

Pregnancy and maternity X

Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian

X

You will need to continue to a full Equality Impact Assessment if the following have been highlighted:

You have ticked “Yes” in any column above and

No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or

Major service redesign or development

8. Please indicate if a full equality analysis is recommended. Yes No X

9. If you are not recommending a Full Impact assessment please explain why.

Signature of policy developer / lead manager / director Date of completion and submission

Names and signatures of members carrying out the Screening Assessment

1. Dr Paul Munyard 2.

Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust’s web site. Signed _______________ Date ________________

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