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NICE clinical guideline: antibiotics for the prevention and treatment of early-onset neonatal infection
  1. Emma Caffrey Osvald1,
  2. Philippa Prentice2
  1. 1Neonatal Unit, Birmingham Women's Hospital, Birminghamm, UK
  2. 2Department of Paediatrics, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK
  1. Correspondence to Dr Emma Caffrey Osvald, Neonatal Unit, Birmingham Women's Hospital, Mindelsohn Way, Birmingham B15 2TG, UK; ecosvald{at}

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Information about current guideline

Early-onset neonatal infection, defined as infection within 72 h of birth, is a significant cause of mortality and morbidity,1 where Group B streptococcus (GBS) is most frequently responsible.1 ,2 The National Institute for Health and Clinical Excellence (NICE) guideline: ‘Antibiotics for early-onset neonatal infection: antibiotics for the prevention and treatment of early-onset neonatal infection’1 was published in August 2012. It aims to help identify those neonates at risk of infection, to promote prompt treatment for neonates with suspected infection and to minimise antibiotic exposure to those babies who do not have early-onset neonatal infection. The guideline was developed by the National Collaborating Centre for Women's and Children's Health.

Previous guideline

There are no previous detailed national guidelines on the management of early-onset neonatal sepsis. The Royal College of Obstetricians and Gynaecologists published a guideline in 2003 (updated 2012) focusing on prevention of GBS, which included some aspects of the management of early-onset neonatal sepsis.2

Box 2


Link to NICE guideline and full guideline

English link to public information on antibiotics for early-onset neonatal infection

Antibiotics for early-onset neonatal infection podcast with Dr Mark Turner

Key issues the guideline recommends

For mothers

  • Offering intrapartum antibiotics to any woman who has had a previous baby with invasive GBS infection or who has GBS colonisation, bacteriuria or infection during the pregnancy.

  • Considering intrapartum antibiotics for any term pregnancy with rupture of membranes lasting more than 18 h or in preterm pregnancy with prelabour rupture of membranes.

For recognising the septic neonate

  • Identifying risk factors for early sepsis and assessing for clinical indicators suggestive of a septic baby. Those strongly suggestive of sepsis are defined ‘red flags’ (box 1).

  • Identifying clinical indicators and risk factors classified as ‘non-red flag’. These include: maternal GBS colonisation, bacteriuria or infection in the current pregnancy, prelabour rupture of membranes, as well as feed intolerance, jaundice in the baby within 24 h of birth and signs of respiratory distress.

    Box 1

    Red flags

    • Parenteral antibiotics given to the mother for confirmed or suspected invasive bacterial infection

    • Suspected or confirmed infection in another baby where there is a multiple pregnancy

    • Respiratory distress starting more than 4 h after birth

    • Seizures

    • Need for mechanical ventilation in a term baby

    • Signs of shock.

For management of suspected neonatal sepsis

  • Commencing antibiotic treatment in the neonate if one ‘red flag’ or more than one ‘non-red flag’ risk factor or clinical indicator is present.

  • Taking blood cultures and C-reactive protein (CRP) before starting antibiotics (see table 1).

  • Doing a lumbar puncture (LP) if there is strong suspicion of sepsis or clinical signs of meningitis.

  • Using benzylpenicillin and gentamicin as first-line antibiotics.

  • Being mindful that different antibiotic regimes are recommended for specific infections, for example in meningitis or umbilical infection. Adhere to your local guidelines and refer to relevant NICE guidelines.

  • Rechecking CRP after 18–24 h after commencing antibiotics.

  • Consider stopping antibiotics after 36 h if the blood culture is negative, CRP remains low and the neonate is clinically stable.

  • Treating for a minimum 7-day course of intravenous antibiotics is suggested where there is a strong suspicion of sepsis or a positive blood culture. However, this may vary depending on the pathogen and the clinical status of the baby. When in doubt adhere to local policy and microbiology advice.

Table 1

Initial investigations for suspected sepsis

Underlying evidence base/methodology

This, like all NICE recommendations, is based on systematic reviews of research evidence. Where no substantive clinical research evidence was found the recommendation is based on other evidence-based guidelines or the collective experience of the Guideline Development Group (see box 2).

What do I need to know

What should I stop doing?

  • Routinely taking urine microscopy, culture and sensitivites (MC&S) or skin swab MC&S as part of initial investigations.

  • Routinely commencing antibiotics in well babies with only one ‘non-red flag’ clinical indicator or risk factor.

What should I start doing for all neonates?

  • Give antibiotics within 1 h of deciding to treat.

  • Prescribe benzylpenicillin at dosage of 25 mg/kg twice daily and increase to three times daily if clinically concerned.

  • Prescribe gentamicin at a starting dosage of 5 mg/kg 36 hourly.

  • Consider LP in a baby with a CRP ≥10 mg/L.

  • Send swabs that detect chlamydia and gonococcus if purulent conjunctivitis is present.

What can I continue to do as before?

  • Allow parents and carers to make informed decisions about their children's care.

  • Consider monitoring baby's vital signs and clinical condition for at least 12 h if only one risk factor or one clinical indicator for sepsis is present.

  • Achieve trough gentamicin concentration of <2 mg/L.

What should I do differently?

  • Consider stopping antibiotics at 36 h if blood cultures are negative, the baby is clinically well, the suspicion of infection was low and the CRP trend is reassuring.

  • Consider completing the course of intravenous antibiotics in non-hospital setting for babies who are well.

Unresolved controversies

The clinical and cost effectiveness of maternal antenatal GBS screening and subsequent treatment in labour of those identified as GBS positive is unclear. It is also unknown whether there is benefit in treating all women in preterm labour with prophylactic antibiotics, including those with intact membranes. More information is needed to distil which specific risk factors, symptoms and signs are most indicative of early-onset neonatal sepsis. Additionally more evidence is needed to provide us with a cost-effective laboratory investigation to exclude early-onset sepsis. Finally, the duration of the antibiotic course also often remains unclear.

Clinical bottom line

This NICE guideline provides evidence-based best practice advice for management of early-onset neonatal infection which can be serious and fatal.

  • Consider whether intrapartum antibiotics are indicated and should be offered to the labouring woman.

  • Antibiotics are recommended in the neonate if one red flag risk factor or clinical indicator is present.

  • Commence intravenous antibiotics within 1 h of deciding to treat.

  • Choose benzylpenicillin and gentamicin as first-line antibiotics.

  • Minimise antibiotic exposure to the neonate by stopping antibiotics at 36 h if blood cultures are negative, CRP and clinical suspicion of sepsis remains low.

  • Keep families informed and to allow them to be part of the decisions made about their child.


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  • Contributors This article was written by ECO with input from PP.

  • Competing interests None.

  • Provenance and peer review Commissioned; externally peer reviewed.

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