Sepsis - Antibiotics for Early Onset Sepsis in the Newborn

Publication: 07/09/2011  
Last review: 21/02/2017  
Next review: 10/01/2020  
Clinical Guideline
CURRENT 
ID: 2511 
Approved By: Improving Antimicrobial Prescribing Group 
Copyright© Leeds Teaching Hospitals NHS Trust 2017  

 

This Clinical Guideline is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

Sepsis - Antibiotics for Early Onset Sepsis in the Newborn

Summary
Sepsis - Antibiotics for Early Onset Sepsis in the Newborn

Procedure/situation

Prophylaxis recommended?

Evidence level

Prophylaxis aims to prevent

NNT

Antimicrobial dose/route/timing

A. Well term or pre-term infant AND mother given at least 2 doses of GBS prophylactic antibiotics beginning 4 hours or more before delivery (only risk factors are for GBS).

No, but observe

C

-

-

-

B. Well term infant AND mother given any GBS prophylaxis (including a single dose) before delivery (only risk factor is GBS colonisation, in this pregnancy or previous infant with GBS infection)

No antibiotics- 24hrs observations

C

-

-

-

C. Well pre-term infant AND mother given GBS prophylaxis less than 4 hours before delivery (only risk factors are for GBS)

Yes and observe C Early onset GBS sepsis - Benzyl penicillin electronic Medicines Compendium information on Benzyl penicillin 50mg/kg 12-hourly IV for 36 hours - and
Gentamicin iv 5mg/kg 36 hourly if less than 7 days old and 24 hourly if 7 days old or more - until blood culture results available after 36 hours incubation.

D. Well term infant with prolonged (>24 hours) rupture of the membranes (ROM) and no other risk factors

No, but observe C - - -

E. Well pre-term infant with prolonged (>24 hours) ROM

Yes and observe C Early onset GBS sepsis   Benzyl penicillin electronic Medicines Compendium information on Benzyl penicillin 50mg/kg 12-hourly IV for 36 hours - and
Gentamicin iv 5mg/kg 36 hourly less than 7 days old and 24 hourly 7 days old or more - until blood culture results available after 36 hours incubation.

F. Well term or pre-term infant with 2 or more risk factors

Yes and observe C Early onset sepsis (all cause)  

Benzyl penicillin electronic Medicines Compendium information on Benzyl penicillin 50mg/kg 12-hourly IV for 36 hours - and
Gentamicin iv 5mg/kg 36 hourly if less than 7 days old and 24 hourly 7 days old or more - until blood culture results available after 36 hours incubation.

G. Unwell infant

Yes and stabilise C    

Benzyl penicillin electronic Medicines Compendium information on Benzyl penicillin 50mg/kg 12-hourly IV for 36 hours - and
Gentamicin iv 5mg/kg 36 hourly if less than 7 days old and 24 hourly 7 days old or more - until blood culture results available after 36 hours incubation.

Back to top

Background

Neonatal sepsis is a significant cause of morbidity and mortality in the newborn infant. This guideline applies to all newborn infants, unless specifically indicated.

This guideline covers early onset sepsis (EOS) defined as sepsis occurring in the first 72h after birth. A separate guideline is available for late onset sepsis (after 72hours of life).

If sepsis occurs in the first 72 hours after delivery it is due to pathogens acquired from the mother prior to or during birth2. The incidence is about 2/1000 live births. Mortality rates are around 10-15% of infants with EOS3. Length of stay is considerably prolonged compared with their peers.

Predisposing factors (e.g. prolonged rupture of membranes, prematurity) should be sought. The most common pathogens are Group B haemolytic Streptococcus (GBS), E. Coli and Listeria monocytogenes. Other pathogens such as H. Influenzae, gram negative anaerobes, fungi and Chlamydia trachomatis may also be seen.

Guidelines have been published by the National Institute for Clinical Excellence (NICE) that address sepsis in the first 72 hours of life1 and these form the basis of this guideline.

Group B Streptococcus (GBS) Disease

GBS is a common commensal organism present in up to 30% of the genital tract of pregnant women. GBS infection in the newborn has an incidence of 0.5-1/1000 live births with a 10-15% mortality rate. Maternal intrapartum antibiotics have been shown to significantly reduce the incidence of early onset GBS sepsis. It has no effect on late onset GBS sepsis.

Over 90% of GBS sepsis presents within 12 hours of delivery.

Women who had had a previous infant with invasive GBS disease or GBS colonization, bacteruria or urinary infection in the current pregnancy will be offered intrapartum benzylpenicillin as prophylaxis against invasive disease in this baby. Benzylpenicillin prescribed for the mother as prophylaxis will be administered every 4 hours.

Adequate intrapartum prophylaxis is when a baby is born 4 hours or more after the mother received her first dose of benzylpencillin. This may mean the mother has received only one dose of antibiotics.

Inadequate intrapartum prophylaxis is when the baby is born before the mother has received antibiotics less than 4 hours before delivery. This means the infant will need further treatment (see below).

If the mother is receiving clindamycin in place of benzylpenicillin (due to allergy) then adequate cover is gained when the clindamycin is administered to the mother more than 4 hours before delivery.

Information & Support

If there are clinical concerns regarding sepsis during pregnancy or the postnatal period the parents and carers should be informed. Explain

  • The reason for concern
  • The management options
  • Where clinically appropriate give the parents time to consider information and answer any questions

If antibiotic treatment is considered, discuss

  • Rationale for treatment
  • Risks and benefits
  • Observations and investigations required
  • Treatment regime
  • Impact on where mother and baby will be cared for.

Ensure parents understand the impact on their role in the baby’s care, the baby’s feeding options and ensure that written information (see appendix) is provided.
If there have been concerns regarding EOS before discharge parent should be advised to seek medical advice if the baby is

  • Showing abnormal behaviour (inconsolable crying, listlessness)
  • Unusually floppy
  • Feeding difficulties
  • Abnormal temperature unexplained by environmental factors
  • Has rapid breathing or
  • Has a change in skin colour

Upon discharge the baby’s carer’s and GP should have information if the baby is considered at risk of infection. Ensure a clear discharge plan is in place.
If the baby has had GBS advise the mother

  • There will be an increased risk of EOS in the next pregnancy
  • She should inform her maternity care team that the previous baby had invasive GBS
  • Antibiotics in labour would be recommended

Inform the GP in writing of the same.

Back to top

Clinical Diagnosis

Babies may be at risk of early onset sepsis or actually be unwell. The tables below indicate the risk factors and the clinical signs and symptoms (clinical indicators) that suggest a baby is at risk or may be septic.

The red flags are risk factors or clinical indicators that should prompt a high level of concern and are an indication for antibiotics on their own.

Risk Factors for EOS

Red flag

Invasive GBS infection in a previous baby

 

Maternal GBS colonization, bacteruria or infection in the current pregnancy

 

Prelabour rupture of membranes

 

Preterm birth following spontaneous labour

 

Suspected or confirmed prelabour rupture of membranes (more than 18 hours) in a preterm birth

 

Maternal intrapartum fever of greater than 38°C

 

Suspected or confirmed chorioamnionitis

 

Parenteral antibiotic treatment given to mother at any time during labour or the 24 hours before or after it. (not including intrapartum prophylaxis)

Suspected or confirmed sepsis in the sibling of a multiple pregnancy


Clinical Indicator

Red flag

Altered behaviour or responsiveness

 

Feed intolerance (vomiting, excessive gastric aspirate, abdominal distension)

 

Abnormal heart rate (tachy or bradycardia)

 

Respiratory distress

 

Respiratory distress starting more than 4 hours after birth

Increased oxygen requirement

 

Increased respiratory support

 

Need for ventilation in a term infant

Early onset jaundice (within first 24 hours)

 

Apnoea

 

Temperature instability

 

Poor peripheral perfusion, cool extremities, prolonged capillary refill time

Hypo or hyperglycaemia

 

Metabolic acidosis

 

Signs of local infection

 

Encephalopathy

 

Seizures

Persistent pulmonary hypertension

 

Need for cardio-pulmonary resuscitation

 

Coagulopathy or thrombocytopenia

 

Oliguria persisting beyond 24 hours of life

 

After delivery

  • When it has been decided to treat the baby with antibiotics they should be administered within 1 hour of that decision
  • If there are any risk factors or clinical indicators for sepsis assess the baby clinically, including history, examination and measurement of vital signs.
  • If the baby has ANY red flags, or 2 or more risk factors or clinical indicators then perform investigations and initiate antibiotic treatment.
  • If a baby only has one risk factor/clinical indicator and NO red flags using clinical judgement decide
    • Is it safe to withhold antibiotics?
    • Should the baby have regular observations (see below)?

Babies that do not require antibiotics but should have regular observations are

  • Well term babies (≥37 weeks) with ruptured membranes >24hours
  • Well infants with maternal GBS and adequate maternal intrapartum prophylaxis (at least 4 hours of antimicrobial cover)
  • Observations should include monitoring of the vital signs and clinical con³dition. This should be documented on the specific chart (see appendix) at 0,1 and 2 hours then 2 hourly until 12 hours of age.
  • If clinical concerns arise request medical review to consider investigation and treatment
  • If there are no clinical concerns during this time the baby may be discharged with advice, information and reassurance to the carers.

If maternal colonization with GBS is identified after birth but within the first 72 hours of life ask the main carer or health professional if there are any concerns with the baby’s condition, identify any other risk factors and look for clinical indicators of infection. Use this assessment to decide on clinical management.

Back to top

Investigation

If a baby has risk factors or clinical indicators for EOS perform the following investigations before starting antibiotics:

  • Blood culture
  • Full blood count (FBC) & C reactive protein (CRP)
  • Lumbar puncture should be considered if there is a high index of suspicion for sepsis, signs of meningitis or a raised CRP.
    Do not delay starting antibiotics to perform an LP. Perform it as soon as possible after the antibiotics
  • Chest x-ray if respiratory signs

Other investigations are not routinely required for EOS (e.g. urine, skin swabs)
In babies with signs of conjunctivitis - see guideline
In babies with signs of umbilical infection (purulent discharge, erythema, swelling etc) perform investigation as above with additional swabs of discharge/skin.
The CRP should be repeated after 18-24 hours.

Back to top

Treatment
Non-Antimicrobial Treatment

If a baby is unwell then ensure stabilization/resuscitation is initiated promptly.
Ensure the baby is cared for in the ward that can best accommodate his/her needs.
Observations should be carried out as below:

Scenario

Observations

Maternal GBS with adequate intrapartum prophylaxis so baby not requiring antibiotics

OR

Prolonged rupture membranes ( >24hours) in a well term infant so baby not requiring antibiotics

Observations at 1 & 2 hours of age and then 2 hourly until 12 hours old.
If no clinical concerns at this time baby may be discharged home.

Maternal GBS with inadequate intrapartum prophylaxis

OR

2 or more risk factors or clinical indicators for EOS

Observations at 1 & 2 hours of age and then 2 hourly until 12 hours old. Then 4 hourly until antibiotics are stopped.

Back to top

Empirical Antimicrobial Treatment
Babies receiving first antibiotics (within 72 hours of birth)

Benzyl penicillin electronic Medicines Compendium information on Benzyl penicillin iv 50mg/kg every 12 hours and
Gentamicin iv 5mg/kg 36 hourly if less than 7 days old and 24 hourly 7 days old or more - until blood culture results available after 36 hours incubation.

All antibiotics are given intravenously for the duration of the course.

Back to top

Directed Antimicrobial Treatment (when microbiology results are known)

Blood culture results should be reviewed at 36 hours of incubation.
If

  • the blood culture is negative
  • initial suspicion of sepsis was not strong
  • baby’s clinical condition is good
  • CRP is reassuring

Then antibiotics may be stopped.
If antibiotics are to continue any culture growth should be discussed with microbiology and the consultant neonatologist.

Back to top

Duration of Treatment
Consider inserting a peripheral long line if duration of treatment more than 5 days

Infection

Duration of antibiotics

GBS septicaemia

7 days
Gentamicin should be stopped after discussion with microbiologist

GBS meningitis

14 days
Gentamicin should be stopped after 48 hours

E. Coli septicaemia

7 days

E. Coli meningitis

21 days

Any other organisms should be discussed with microbiology

Back to top

Switch to oral agent(s)
No oral antibiotics in this age group

Back to top

Provenance

Record: 2511
Objective:

Aims

  • To improve the diagnosis and management of infection within the first 72 hours after birth

Objectives

  • To provide evidence-based recommendations for appropriate diagnosis and investigation of early onset neonatal sepsis
  • To provide evidence-based recommendations for appropriate non-antimicrobial management of onset neonatal sepsis
  • To provide evidence-based recommendations for appropriate empirical and directed antimicrobial therapy of onset neonatal sepsis
  • To recommend appropriate dose, route of administration and duration of antimicrobial agents.
Clinical condition:

Early onset sepsis in the newborn

Target patient group: Babies in the first 72 hours of life
Target professional group(s): Secondary Care Doctors
Secondary Care Nurses
Pharmacists
Adapted from:

Evidence base

References

  1. National Institute for Health and Care Excellence (2012) Antibiotics for Early Onset Neonatal Infection CG149. London: National Institute for Health and Care Excellence.
  2. BNFc December 2015 update. Accessed via www.medicinescomplete.com

Evidence levels:
A. Meta-analyses, randomised controlled trials/systematic reviews of RCTs
B. Robust experimental or observational studies
C. Expert consensus.
D. Leeds consensus. (where no national guidance exists or there is wide disagreement with a level C recommendation or where national guidance documents contradict each other)

Approved By

Improving Antimicrobial Prescribing Group

Document history

LHP version 1.0

Related information

Not supplied

Equity and Diversity

The Leeds Teaching Hospitals NHS Trust is committed to ensuring that the way that we provide services and the way we recruit and treat staff reflects individual needs, promotes equality and does not discriminate unfairly against any particular individual or group.