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Neonatal infection: antibiotics for prevention and treatment

About

What is covered

This NICE Pathway covers preventing bacterial infection in healthy babies of up to and including 28 days corrected gestational age, treating pregnant women whose unborn baby is at risk of infection, and caring for babies of up to and including 28 days corrected gestational age with a suspected or confirmed bacterial infection. It aims to reduce delays in recognising and treating infection and prevent unnecessary use of antibiotics. The guidance does not cover viral infections.
The guidance uses the terms 'woman' or 'mother' throughout. These should be taken to include people who do not identify as women but are pregnant or have given birth. Similarly, where the term 'parents' is used, this should be taken to include other people who are the baby's primary caregivers and single parents.

Updates

Updates to this NICE Pathway

20 April 2021 Updated and renamed on publication of neonatal infection: antibiotics for prevention and treatment (NICE guideline NG195).
17 December 2014 Neonatal infection (NICE quality standard 75) added.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Short Text

Everything NICE has said on antibiotics for preventing and treating neonatal infection in an interactive flowchart

What is covered

This NICE Pathway covers preventing bacterial infection in healthy babies of up to and including 28 days corrected gestational age, treating pregnant women whose unborn baby is at risk of infection, and caring for babies of up to and including 28 days corrected gestational age with a suspected or confirmed bacterial infection. It aims to reduce delays in recognising and treating infection and prevent unnecessary use of antibiotics. The guidance does not cover viral infections.
The guidance uses the terms 'woman' or 'mother' throughout. These should be taken to include people who do not identify as women but are pregnant or have given birth. Similarly, where the term 'parents' is used, this should be taken to include other people who are the baby's primary caregivers and single parents.

Updates

Updates to this NICE Pathway

20 April 2021 Updated and renamed on publication of neonatal infection: antibiotics for prevention and treatment (NICE guideline NG195).
17 December 2014 Neonatal infection (NICE quality standard 75) added.

Sources

NICE guidance and other sources used to create this interactive flowchart.
Neonatal infection (2014) NICE quality standard 75

Quality standards

Quality statements

Intrapartum antibiotics

This quality statement is taken from the neonatal infection quality standard. The quality standard defines clinical best practice for neonatal infection and should be read in full.

Quality statement

Pregnant women whose babies are at risk of early-onset neonatal infection are offered intrapartum antibiotic prophylaxis and given the first dose as soon as possible.

Rationale

Giving intrapartum antibiotic prophylaxis to women whose babies are at risk of early-onset neonatal infection (for example, from group B streptococcus) can prevent early-onset neonatal infection. The first dose should be given as soon as possible after the onset of labour because intrapartum antibiotic prophylaxis is most effective when the baby has sufficient exposure to the antibiotic.

Quality measures

Structure
Evidence of local arrangements to ensure that pregnant women whose babies are at risk of early onset neonatal infection are offered intrapartum antibiotic prophylaxis and given the first dose as soon as possible.
Data source: Local data collection.
Process
a) Proportion of pregnant women whose babies are at risk of early-onset neonatal infection who receive intrapartum antibiotic prophylaxis.
Numerator – the number in the denominator who receive intrapartum antibiotic prophylaxis.
Denominator – the number of pregnant women whose babies are at risk of early-onset neonatal infection.
Data source: Local data collection.
b) Proportion of pregnant women receiving intrapartum antibiotic prophylaxis who are given it as soon as possible.
Numerator – the number in the denominator whose intrapartum antibiotic prophylaxis is given as soon as possible.
Denominator – the number of pregnant women who receive intrapartum antibiotic prophylaxis.
Data source: Local data collection.
Outcome
Rates of early-onset neonatal infection.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (maternity care services) ensure that systems and protocols are in place to enable intrapartum antibiotic prophylaxis to be offered to pregnant women whose babies are at risk of early-onset neonatal infection and ensure that they are given the first dose as soon as possible.
Healthcare professionals (for example, midwives and doctors) adhere to protocols and offer intrapartum antibiotic prophylaxis to pregnant women whose babies are at risk of early-onset neonatal infection, ensuring that they are given the first dose as soon as possible and record this.
Commissioners (clinical commissioning groups) specify that maternity care providers have systems and protocols in place for healthcare professionals to offer intrapartum antibiotic prophylaxis to pregnant women whose babies are at risk of early-onset neonatal infection and ensure that they are given the first dose as soon as possible.
Pregnant women whose babies are at risk of early-onset neonatal infection are offered antibiotics and given the first dose as soon as possible after their labour has started.

Source guidance

Definitions of terms used in this quality statement

As soon as possible
As soon as possible after labour starts or as soon as infection is suspected in the case of chorioamnionitis. A suggested definition for audit purposes is that the first dose is given within 1 hour of the onset of active labour, or within 1 hour of admission if the woman is already in active labour. [NICE’s guideline on neonatal infection, recommendation 1.2.4 and expert opinion]
Babies who are at risk of early-onset neonatal infection
Babies are at risk of early-onset neonatal infection if the mother:
  • is in preterm labour, or
  • has group B streptococcal colonisation, bacteriuria or infection during the current pregnancy, or
  • has had group B streptococcal colonisation, bacteriuria or infection in a previous pregnancy, and has not had a negative test for group B streptococcus by enrichment culture or PCR on rectovaginal swab samples collected between 35 and 37 weeks’ gestation or 3 to 5 weeks before the anticipated delivery date in the current pregnancy, or
  • has had a previous baby with an invasive group B streptococcal infection, or
  • has a clinical diagnosis of chorioamnionitis.
Intrapartum antibiotic prophylaxis
The following table indicates which antibiotic to use when giving intrapartum antibiotics for neonatal infection.
Intrapartum antibiotics for neonatal infection
Allergies
Women without chorioamnionitis
Women with chorioamnionitis
No penicillin allergy
Use benzylpenicillin.
Use benzylpenicillin plus gentamicin plus metronidazole.
Penicillin allergy that is not severe
Use cephalosporin with activity against group B streptococcus (for example cefotaxime). Use with caution. In April 2021 this was an off-label use of cephalosporins. See NICE’s information on prescribing medicines.
Use cephalosporin with activity against group B streptococcus (for example cefotaxime) plus metronidazole. Use with caution. In April 2021 this was an off-label use of cephalosporins. See NICE’s information on prescribing medicines.
Severe penicillin allergy
Consider vancomycin or an alternative antibiotic that would be expected to be active against group B streptococcus based on either sensitivity testing performed on the woman’s isolate or on local antibiotic susceptibility surveillance data. In April 2021 this was an off-label use of vancomycin. See NICE’s information on prescribing medicines.
Consider vancomycin plus gentamicin plus metronidazole or an alternative antibiotic to vancomycin that would be expected to be active against group B streptococcus based on either sensitivity testing performed on the woman’s isolate or on local antibiotic susceptibility surveillance data plus gentamicin plus metronidazole. In April 2021 this was an off-label use of vancomycin. See NICE’s information on prescribing medicines.

Clinical assessment for early-onset neonatal infection

This quality statement is taken from the neonatal infection quality standard. The quality standard defines clinical best practice for neonatal infection and should be read in full.

Quality statement

Pregnant women and newborn babies receive a comprehensive clinical assessment for the risks or indicators of early-onset neonatal infection.

Rationale

A comprehensive clinical assessment can identify babies who are at increased risk, or showing signs, of possible early-onset neonatal infection and enable healthcare professionals to start antibiotic treatment promptly if needed.

Quality measures

Structure
Evidence of local arrangements and written protocols to ensure that pregnant women and newborn babies receive a comprehensive clinical assessment for the risks or indicators of early-onset neonatal infection.
Data source: Local data collection.
Process
a) Proportion of pregnant women who are assessed for risk factors for early-onset neonatal infection.
Numerator – the number in the denominator who are assessed for risk factors for early-onset neonatal infection.
Denominator – the number of pregnant women.
Data source: Local data collection.
b) Proportion of newborn babies who are assessed for clinical indicators of early-onset neonatal infection.
Numerator – the number in the denominator who are assessed for clinical indicators of early-onset neonatal infection.
Denominator – the number of newborn babies.
Data source: Local data collection.
c) Proportion of newborn babies with risk factors or clinical indicators of early-onset neonatal infection who receive an immediate physical examination including an assessment of the vital signs.
Numerator – the number in the denominator who receive an immediate physical examination including an assessment of the vital signs.
Denominator – the number of newborn babies identified with risk factors or clinical indicators of early-onset neonatal infection.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (maternity care services) develop protocols to ensure that healthcare professionals are trained to identify the risk factors and clinical indicators of early-onset neonatal infection and perform a physical examination of the baby (including an assessment of the vital signs) if any have been identified.
Healthcare professionals (for example, midwives and doctors) monitor for risk factors and clinical indicators of early-onset neonatal infection and perform an immediate physical examination of the baby (including an assessment of the vital signs) if any have been identified.
Commissioners (clinical commissioning groups) specify that maternity care providers develop and adhere to protocols to support the identification of risk factors and clinical indicators of early-onset neonatal infection and perform immediate physical assessments of newborn babies if any have been identified.
Pregnant women and newborn babies have an assessment to check whether the baby is at risk of infection.

Source guidance

Definitions of terms used in this quality statement

Comprehensive clinical assessment
Comprehensive clinical assessment for early-onset neonatal infection is a continuing process that begins before the baby is born and continues until 72 hours after the birth. It includes identifying whether there are any risk factors or clinical indicators for early-onset neonatal infection and performing a physical examination of the baby (including an assessment of the vital signs) without delay if any are identified. Red flag risk factors and clinical indicators (defined below) prompt a high level of concern. [Expert opinion]
Risk factors
Red flag risk factor:
  • Suspected or confirmed infection in another baby in the case of a multiple pregnancy.
Other risk factors:
  • Invasive group B streptococcal infection in a previous baby or maternal group B streptococcal colonisation, bacteriuria or infection in the current pregnancy.
  • Preterm birth following spontaneous labour before 37 weeks' gestation.
  • Confirmed rupture of membranes for more than 18 hours before a preterm birth.
  • Confirmed prelabour rupture of membranes at term for more than 24 hours before the onset of labour.
  • Intrapartum fever higher than 38°C if there is suspected or confirmed bacterial infection.
  • Clinical diagnosis of chorioamnionitis.
Clinical indicators
Red flag clinical indicators:
  • Apnoea (temporary stopping of breathing)
  • Seizures
  • Need for cardiopulmonary resuscitation
  • Need for mechanical ventilation
  • Signs of shock.
Other clinical indicators:
  • Altered behaviour or responsiveness
  • Altered muscle tone (for example, floppiness)
  • Feeding difficulties (for example, feed refusal)
  • Feed intolerance, including vomiting, excessive gastric aspirates and abdominal distension
  • Abnormal heart rate (bradycardia or tachycardia)
  • Signs of respiratory distress (including grunting, recession, tachypnoea)
  • Hypoxia (for example, central cyanosis or reduced oxygen saturation level)
  • Persistent pulmonary hypertension of newborns
  • Jaundice within 24 hours of birth
  • Signs of neonatal encephalopathy
  • Temperature abnormality (lower than 36°C or higher than 38°C) unexplained by environmental factors
  • Unexplained excessive bleeding, thrombocytopenia, or abnormal coagulation
  • Altered glucose homeostasis (hypoglycaemia or hyperglycaemia)
  • Metabolic acidosis (base deficit of 10 mmol/litre or greater).
Newborn babies
Babies under 72 hours old. [Adapted from NICE's guideline on neonatal infection, terms used in this guideline definition of early-onset neonatal infection]

Prompt antibiotic treatment for early-onset neonatal infection

This quality statement is taken from the neonatal infection quality standard. The quality standard defines clinical best practice for neonatal infection and should be read in full.

Quality statement

Newborn babies who need antibiotic treatment receive it within 1 hour of the decision to treat.

Rationale

If the decision to treat is made, antibiotic treatment for early-onset neonatal infection should be started without delay (and without waiting for test results) and always within 1 hour to improve clinical outcomes for the baby.

Quality measures

Structure
Evidence of local arrangements to ensure that newborn babies who need antibiotic treatment receive it within 1 hour of the decision to treat.
Data source: Local data collection.
Process
Proportion of newborn babies who need antibiotic treatment who receive it within 1 hour of the decision to treat.
Numerator – the number in the denominator who receive antibiotics within 1 hour of the decision to treat.
Denominator – the number of newborn babies who need antibiotic treatment.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (maternity care services) develop protocols to ensure that healthcare professionals give antibiotic treatment to newborn babies who need it within 1 hour of the decision to treat.
Healthcare professionals (for example, midwives and doctors) adhere to protocols for antibiotic treatment for newborn babies who need it to be started within 1 hour of the decision to treat and record this.
Commissioners (clinical commissioning groups) specify that maternity care providers give antibiotic treatment to newborn babies who need it within 1 hour of the decision to treat the early-onset neonatal infection.
Newborn babies less than 72 hours old who need antibiotic treatment for an infection receive it within 1 hour.

Source guidance

Definitions of terms used in this quality statement

Newborn babies
Babies under 72 hours old. [Adapted from NICE's guideline on neonatal infection, terms used in this guideline definition of early-onset neonatal infection]
Newborn babies who need antibiotic treatment
Babies with any red flag, or with 2 or more ‘non-red flag’ risk factors or clinical indicators.
Risk factors
Red flag risk factor:
  • Suspected or confirmed infection in another baby in the case of a multiple pregnancy.
Other risk factors:
  • Invasive group B streptococcal infection in a previous baby or maternal group B streptococcal colonisation, bacteriuria or infection in the current pregnancy.
  • Preterm birth following spontaneous labour before 37 weeks' gestation.
  • Confirmed rupture of membranes for more than 18 hours before a preterm birth.
  • Confirmed prelabour rupture of membranes at term for more than 24 hours before the onset of labour.
  • Intrapartum fever higher than 38°C if there is suspected or confirmed bacterial infection.
  • Clinical diagnosis of chorioamnionitis.
Clinical indicators
Red flag clinical indicators:
  • Apnoea (temporary stopping of breathing)
  • Seizures
  • Need for cardiopulmonary resuscitation
  • Need for mechanical ventilation
  • Signs of shock.
Other clinical indicators:
  • Altered behaviour or responsiveness
  • Altered muscle tone (for example, floppiness)
  • Feeding difficulties (for example, feed refusal)
  • Feed intolerance, including vomiting, excessive gastric aspirates and abdominal distension
  • Abnormal heart rate (bradycardia or tachycardia)
  • Signs of respiratory distress (including grunting, recession, tachypnoea)
  • Hypoxia (for example, central cyanosis or reduced oxygen saturation level)
  • Persistent pulmonary hypertension of newborns
  • Jaundice within 24 hours of birth
  • Signs of neonatal encephalopathy
  • Temperature abnormality (lower than 36°C or higher than 38°C) unexplained by environmental factors
  • Unexplained excessive bleeding, thrombocytopenia, or abnormal coagulation
  • Altered glucose homeostasis (hypoglycaemia or hyperglycaemia)
  • Metabolic acidosis (base deficit of 10 mmol/litre or greater).

Reassessing antibiotic treatment for early-onset neonatal infection

This quality statement is taken from the neonatal infection quality standard. The quality standard defines clinical best practice for neonatal infection and should be read in full.

Quality statement

Newborn babies who start antibiotic treatment for possible early-onset neonatal infection have their need for it reassessed at 36 hours.

Rationale

Newborn babies should have their antibiotic treatment reassessed 36 hours after starting treatment to ensure that they are not receiving antibiotics unnecessarily. Reassessment (including consideration of any blood test results) is needed so that antibiotic treatment can be stopped if there are clinical indications that a baby does not have an infection. This will help to improve safety by reducing the likelihood of local antimicrobial resistance as well as improve the experience of the postnatal period for these babies and their parents or carers.

Quality measures

Structure
Evidence of local arrangements to ensure that newborn babies who start antibiotic treatment for possible early-onset neonatal infection have their need for it reassessed at 36 hours.
Data source: Local data collection.
Process
Proportion of newborn babies who start antibiotic treatment for possible early-onset neonatal infection who have their need for it reassessed at 36 hours.
Numerator – the number in the denominator who have their need for antibiotic treatment reassessed at 36 hours.
Denominator – the number of newborn babies who start antibiotic treatment for possible early-onset neonatal infection.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (maternity care services) have protocols in place to ensure that healthcare professionals reassess antibiotic treatment at 36 hours and have systems in place for blood culture results to be returned within 36 hours.
Healthcare professionals (for example, midwives and doctors) adhere to protocols and reassess the need for antibiotic treatment at 36 hours to enable antibiotic treatment to be stopped if there are clinical indications that a baby does not have an infection.
Commissioners (clinical commissioning groups) specify that maternity care providers reassess the need for antibiotic treatment at 36 hours and include consideration of blood culture results.
Newborn babies being given antibiotic treatment for an infection have their treatment checked at 36 hours to see whether they need to continue it.

Source guidance

Definitions of terms used in this quality statement

Newborn babies
Babies under 72 hours old. [Adapted from NICE's guideline on neonatal infection, terms used in this guideline definition of early-onset neonatal infection]
Reassessment of the need for antibiotic treatment
Includes blood culture, C-reactive protein level, clinical condition and the strength of the initial clinical suspicion of infection. Antibiotic treatment may be stopped if blood culture is negative, initial suspicion of infection was not strong, the baby has no clinical indicators of infection and C-reactive protein levels are reassuring. [NICE's guideline on neonatal infection, recommendation 1.6.3]
Hospitals should consider establishing systems to provide blood culture results 36 hours after starting antibiotic treatment to facilitate the timely discontinuation of treatment. [NICE's guideline on neonatal infection, recommendation 1.6.4]

Information and support for identification of neonatal infection

This quality statement is taken from the neonatal infection quality standard. The quality standard defines clinical best practice for neonatal infection and should be read in full.

Quality statement

Parents or carers of newborn babies in whom early-onset neonatal infection has been a concern are given verbal and written information about neonatal infection before discharge.

Rationale

Prompt identification of neonatal infection is essential to ensure that babies receive appropriate treatment as soon as possible to prevent complications and achieve the best clinical outcomes. Advising parents or carers about what to look for and when to contact a healthcare professional will help them recognise signs of infection promptly and avoid unnecessary delay in treatment of the baby.

Quality measures

Structure
Evidence of local arrangements and protocols to ensure that parents or carers of newborn babies in whom early-onset neonatal infection has been a concern are given verbal and written information about neonatal infection before discharge.
Data source: Local data collection.
Process
Proportion of parents or carers of newborn babies in whom early-onset neonatal infection has been a concern who are given verbal and written information about neonatal infection before discharge.
Numerator – the number in the denominator whose parents or carers receive verbal and written information about neonatal infection before discharge.
Denominator – the number of newborn babies in whom early-onset neonatal infection has been a concern.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (secondary care services) ensure that verbal and written information about neonatal infection (including what to look for and who to contact if they are concerned) is available before discharge for parents or carers of newborn babies in whom there have been concerns about early-onset neonatal infection.
Healthcare professionals (for example, midwives and doctors) discuss neonatal infection with parents or carers of newborn babies in whom there have been concerns about early-onset neonatal infection, and give them written information before discharge, including what to look for and who to contact if they are concerned.
Commissioners (clinical commissioning groups) specify that services have protocols in place to ensure that verbal and written information about neonatal infection is available for parents or carers of newborn babies in whom there have been concerns about early-onset neonatal infection. They also ensure that there is access to relevant healthcare professionals for parents or carers who are concerned about neonatal infection.
Parents or carers of newborn babies who may be at risk of developing an infection have a healthcare professional discuss this with them and give them written information about infection in newborn babies before they leave hospital. The information should include how to check whether the baby might have an infection and who to contact if they are concerned.

Source guidance

Definitions of terms used in this quality statement

Babies in whom early-onset neonatal infection is a concern
Babies with any of the risk factors or clinical indicators below, either before birth or during the first 72 hours after birth. Red flag risk factors and clinical indicators prompt a high level of concern.
Risk factors
Red flag risk factor:
  • Suspected or confirmed infection in another baby in the case of a multiple pregnancy.
Other risk factors:
  • Invasive group B streptococcal infection in a previous baby or maternal group B streptococcal colonisation, bacteriuria or infection in the current pregnancy.
  • Preterm birth following spontaneous labour before 37 weeks' gestation.
  • Confirmed rupture of membranes for more than 18 hours before a preterm birth.
  • Confirmed prelabour rupture of membranes at term for more than 24 hours before the onset of labour.
  • Intrapartum fever higher than 38°C if there is suspected or confirmed bacterial infection.
  • Clinical diagnosis of chorioamnionitis.
Clinical indicators
Red flag clinical indicators:
  • Apnoea (temporary stopping of breathing)
  • Seizures
  • Need for cardiopulmonary resuscitation
  • Need for mechanical ventilation
  • Signs of shock.
Other clinical indicators:
  • Altered behaviour or responsiveness
  • Altered muscle tone (for example, floppiness)
  • Feeding difficulties (for example, feed refusal)
  • Feed intolerance, including vomiting, excessive gastric aspirates and abdominal distension
  • Abnormal heart rate (bradycardia or tachycardia)
  • Signs of respiratory distress (including grunting, recession, tachypnoea)
  • Hypoxia (for example, central cyanosis or reduced oxygen saturation level)
  • Persistent pulmonary hypertension of newborns
  • Jaundice within 24 hours of birth
  • Signs of neonatal encephalopathy
  • Temperature abnormality (lower than 36°C or higher than 38°C) unexplained by environmental factors
  • Unexplained excessive bleeding, thrombocytopenia, or abnormal coagulation
  • Altered glucose homeostasis (hypoglycaemia or hyperglycaemia)
  • Metabolic acidosis (base deficit of 10 mmol/litre or greater).
[Adapted from NICE's guideline on neonatal infection, recommendations 1.1.2, 1.1.5, 1.3.3 and 1.3.4]
Discharge
When a baby is discharged from the hospital or midwifery led unit or in the immediate postnatal period if the baby is born at home. [NICE's guideline on neonatal infection, recommendation 1.1.5].
Information about neonatal infection
Verbal and written information for parents and carers that they should seek urgent medical help (for example, from NHS 111, their GP or an accident and emergency department) if they are concerned that the baby:
  • is showing abnormal behaviour (for example, inconsolable crying or listlessness) or
  • is unusually floppy or
  • has an abnormal temperature unexplained by environmental factors (lower than 36°C or higher than 38°C) or
  • has abnormal breathing (rapid breathing, difficulty in breathing or grunting) or
  • has a change in skin colour (for example where the baby becomes very pale, blue/grey or dark yellow) or
  • has developed new difficulties with feeding.

Equality and diversity considerations

Information about neonatal infection should be accessible to parents or carers with additional needs such as physical, sensory or learning disabilities, and to parents or carers who do not speak or read English. Parents or carers of babies in whom early-onset neonatal infection has been a concern in any setting should have access to an interpreter or advocate if needed.

Antibiotic treatment for late-onset neonatal infection: placeholder statement

This quality statement is taken from the neonatal infection quality standard. The quality standard defines clinical best practice for neonatal infection and should be read in full.

What is a placeholder statement?

A placeholder statement is an area of care that was prioritised by the quality standards advisory committee but for which no source guidance was available. A placeholder statement indicated the need for evidence-based guidance to be developed in this area.

Rationale

Late-onset neonatal infection (infection arising more than 72 hours after birth) has a higher incidence than early-onset neonatal infection (infection arising within 72 hours of birth) and the spectrum of causative microorganisms is broader than in early-onset infection. A quality statement on the appropriate use of antibiotics in late-onset neonatal bacterial infection could help to improve clinical outcomes for babies and reduce the likelihood of antimicrobial resistance in babies and neonatal units.
The updated NICE guideline on neonatal infection now includes recommendations on antibiotics for late-onset neonatal infection and duration of antibiotic treatment for late-onset neonatal infection. This placeholder statement will be updated when this quality standard is next reviewed.

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Information for the public

NICE has written information for the public on each of the following topics.

Pathway information

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Supporting information

Intrapartum antibiotics for neonatal infection

Allergies
Women without chorioamnionitis
Women with chorioamnionitis
No penicillin allergy
Use benzylpenicillin.
Use benzylpenicillin plus gentamicin plus metronidazole.
Penicillin allergy that is not severe
Use cephalosporin with activity against group B streptococcus (for example cefotaxime).
Use with caution.
In April 2021 this was an off-label use of cephalosporins. See prescribing medicines at NICE website.
Use cephalosporin with activity against group B streptococcus (for example cefotaxime) plus metronidazole.
Use with caution.
In April 2021 this was an off-label use of cephalosporins. See prescribing medicines at NICE website
Consider:
Vancomycin or
An alternative antibiotic that would be expected to be active against group B streptococcus based on either sensitivity testing performed on the woman's isolate or on local antibiotic susceptibility surveillance data.
In April 2021 this was an off-label use of vancomycin. See prescribing medicines at NICE website.
Consider:
Vancomycin plus gentamicin plus metronidazole or
An alternative antibiotic to vancomycin that would be expected to be active against group B streptococcus based on either sensitivity testing performed on the woman's isolate or on local antibiotic susceptibility surveillance data plus gentamicin plus metronidazole.
In April 2021 this was an off-label use of vancomycin. See prescribing medicines at NICE website.

Risk factors for early-onset neonatal infection, including 'red flags'

Red flag risk factor:
  • Suspected or confirmed infection in another baby in the case of a multiple pregnancy.
Other risk factors:
  • Invasive group B streptococcal infection in a previous baby or maternal group B streptococcal colonisation, bacteriuria or infection in the current pregnancy.
  • Pre-term birth following spontaneous labour before 37 weeks' gestation.
  • Confirmed rupture of membranes for more than 18 hours before a pre-term birth.
  • Confirmed prelabour rupture of membranes at term for more than 24 hours before the onset of labour.
  • Intrapartum fever higher than 38°C if there is suspected or confirmed bacterial infection.
  • Clinical diagnosis of chorioamnionitis.

Clinical indicators of possible early-onset neonatal infection (observations and events in the baby), including 'red flags'

Red flag clinical indicators:
  • Apnoea (temporary stopping of breathing)
  • Seizures
  • Need for cardiopulmonary resuscitation
  • Need for mechanical ventilation
  • Signs of shock
Other clinical indicators:
  • Altered behaviour or responsiveness
  • Altered muscle tone (for example, floppiness)
  • Feeding difficulties (for example, feed refusal)
  • Feed intolerance, including vomiting, excessive gastric aspirates and abdominal distension
  • Abnormal heart rate (bradycardia or tachycardia)
  • Signs of respiratory distress (including grunting, recession, tachypnoea)
  • Hypoxia (for example, central cyanosis or reduced oxygen saturation level)
  • Persistent pulmonary hypertension of newborns
  • Jaundice within 24 hours of birth
  • Signs of neonatal encephalopathy
  • Temperature abnormality (lower than 36°C or higher than 38°C) unexplained by environmental factors
  • Unexplained excessive bleeding, thrombocytopenia, or abnormal coagulation
  • Altered glucose homeostasis (hypoglycaemia or hyperglycaemia)
  • Metabolic acidosis (base deficit of 10 mmol/litre or greater)

Clinical indicators of possible late-onset neonatal infection (observations and events in the baby)

Category
Indicators
Behaviour
Parent or care-giver concern for change in behaviour
Appears ill to a healthcare professional
Does not wake, or if roused does not stay awake
Weak high-pitched or continuous cry
Respiratory
Raised respiratory rate: 60 breaths per minute or more
Grunting
Apnoea
Oxygen saturation of less than 90% in air or increased oxygen requirement over baseline
Circulation and hydration
Persistent tachycardia:160 beats per minute or more
Persistent bradycardia: heart rate less than 100 beats per minute
Skin
Mottled or ashen appearance
Cyanosis of skin, lips or tongue
Non-blanching rash of skin
Other
Temperature 38°C or more unexplained by environmental factors
Temperature less than 36°C unexplained by environmental factors
Alterations in feeding pattern
Abdominal distension
Seizures
Bulging fontanelle
If giving antibiotics because of clinical concerns about possible early-onset neonatal infection or late-onset neonatal infection, discuss with parents and carers:
  • the reason for the treatment
  • the risks and benefits in relation to their baby's circumstances
  • the observations and investigations that might be needed to guide treatment (for example, to help decide when to stop treatment)
  • the preferred antibiotic regimen (including how it will be delivered) and likely duration of treatment
  • the impact, if any, on where the woman or her baby will be cared for.

During treatment

Reassure parents and carers that they will be able to continue caring for and holding their baby according to their wishes, unless the baby is too ill to allow this. If the severity of the baby's illness means they need to change the way they care for the baby, discuss this with them.

During and/or after treatment

Offer parents and carers contact details of organisations that provide parent support, befriending, counselling, information and advocacy.
If a baby has been treated for suspected or confirmed neonatal infection:
  • advise the parents and carers about potential long-term effects of the baby's illness and likely patterns of recovery, and reassure them if no problems are anticipated
  • take account of parents' and carers' concerns when providing information and planning follow-up.
When a baby who has had a group B streptococcal infection is discharged from hospital:
  • advise the woman that if she becomes pregnant again:
    • that her new baby will be at increased risk of early-onset group B streptococcal infection
    • she should inform her maternity care team that she has had a previous baby with a group B streptococcal infection
    • her maternity care team will offer her antibiotics in labour
  • inform the woman's GP in writing that there is a risk of:
    • group B streptococcal infection recurrence in the baby and
    • group B streptococcal infection in babies in future pregnancies.
Before any baby is transferred home from the hospital or midwifery-led unit (or in the immediate postnatal period in the case of babies born at home), advise parents and carers to seek urgent medical help (for example, from NHS 111, their GP, or an accident and emergency department) if they are concerned that their baby:
  • is showing abnormal behaviour (for example, inconsolable crying or listlessness), or
  • is unusually floppy or
  • has an abnormal temperature unexplained by environmental factors (lower than 36°C or higher than 38°C) or
  • has abnormal breathing (rapid breathing, difficulty in breathing or grunting) or
  • has a change in skin colour (for example where the baby becomes very pale, blue/grey or dark yellow), or
  • has developed new difficulties with feeding.
Give the advice both in person, and as written information and advice for them to take away.
When there has been a clinical concern about neonatal infection in a baby, make a post-discharge management plan, taking into account factors such as:
  • the level of the initial clinical concern
  • the presence of risk factors
  • parents' and carers' concerns.
Do not routinely give antibiotic treatment to babies without risk factors for infection or clinical indicators or laboratory evidence of possible infection.

Unknown causative pathogen

If a baby is in a neonatal unit and meningitis is suspected but the causative pathogen is unknown (for example, because the cerebrospinal fluid Gram stain is uninformative), treat with intravenous amoxicillin and cefotaxime.

Gram-negative infection

If a baby is in a neonatal unit and meningitis is shown (by either cerebrospinal fluid Gram stain or culture) to be caused by Gram-negative infection, stop amoxicillin and treat with cefotaxime alone.

Gram-positive infection

If a baby is in a neonatal unit and meningitis is shown (by cerebrospinal fluid Gram stain) to be caused by a Gram-positive bacterium:
  • continue treatment with intravenous amoxicillin and cefotaxime while waiting for the cerebrospinal fluid culture result and
  • seek expert microbiological advice.
If the cerebrospinal fluid culture identifies a Gram-positive bacterium other than group B streptococcus or listeria, seek expert microbiological advice on management.

Group B streptococcus

If the cerebrospinal fluid culture is positive for group B streptococcus, consider changing the antibiotic treatment to:
  • benzylpenicillin 50 mg/kg every 12 hours, normally for at least 14 days and
  • gentamicin, with:
    • a starting dosage of 5 mg/kg every 36 hours
    • subsequent doses and intervals adjusted if necessary based on clinical judgement and blood gentamicin concentrations
    • treatment lasting for 5 days.
When prescribing gentamicin, be aware that:
  • the summary of product characteristics recommends a dosage of 4 to 7 mg/kg/day administered in a single dose
  • the evidence reviewed for the guidance supports a starting dosage of 5 mg/kg every 36 hours administered in a single dose.
In 2021, a dosage of 5 mg/kg every 36 hours is an off-label use of gentamicin. See prescribing medicines at NICE website.
If a second dose of gentamicin is given, this should usually be 36 hours after the first dose. Use a shorter interval if clinical judgement suggests this is needed, for example if:
  • the baby appears very ill
  • the blood culture shows a Gram-negative infection.
Take account of blood gentamicin concentrations when deciding on subsequent gentamicin dosing regimen (see therapeutic drug monitoring for gentamicin in antibiotic choice).

Listeria

If the blood culture or cerebrospinal fluid culture is positive for listeria, consider stopping cefotaxime and treating with amoxicillin and gentamicin.

Discharge after antibiotic treatment for meningitis

After antibiotic treatment, consider prompt discharge of the baby from hospital, with support for the parents and carers and a point of contact for advice.
If giving a second dose of gentamicin, measure the trough blood gentamicin concentration immediately before giving the second dose. Take the trough concentrations into account before giving the third dose of gentamicin.
Repeat the measurement of trough concentrations immediately before every subsequent third dose of gentamicin, or more frequently if necessary (for example, if there has been concern about previous trough concentrations or renal function).
Hospital services should make blood gentamicin concentrations available to healthcare professionals in time to inform the next dosage decision.
Adjust the gentamicin dose interval, aiming to achieve trough concentrations of less than 2 mg/litre. If the course of gentamicin lasts for more than 3 doses, aim for a trough concentration of less than 1 mg/litre.
Do not withhold a dose of gentamicin because of delays in getting a trough concentration measurement, unless there is evidence of impaired renal function (for example, an elevated serum urea or creatinine concentration, or anuria).
Consider measuring peak blood gentamicin concentrations in selected babies, such as in those with:
  • oedema
  • macrosomia (birthweight more than 4.5 kg)
  • an unsatisfactory response to treatment
  • proven Gram-negative infection.
When measuring peak blood gentamicin concentrations, take the measurement 1 hour after starting gentamicin.
If a baby has a Gram-negative or staphylococcal infection, consider increasing the dose of gentamicin if the peak concentration is less than 8 mg/litre.
Using clinical judgement, consider completing a course of intravenous antibiotics outside of hospital (for example, at home or through visits to a midwifery-led unit) in babies who are well and for whom there are no ongoing concerns if there is adequate local support.
When deciding on the appropriate care setting for a baby, take into account the baby's clinical needs and the competencies needed to ensure safe and effective care (for example, the insertion and care of intravenous cannulas).

Glossary

(neonatal infection less than 72 hours after birth)
(neonatal infection 72 hours or more after birth)
(the level of gentamicin in the baby's bloodstream shortly after administration: the blood sample is usually taken about 1 hour after giving the drug; high peak concentrations of gentamicin are necessary to kill bacteria)
(a history of allergy to penicillin with effects that are clearly likely to be allergic in nature such as anaphylaxis, respiratory distress, angioedema or urticaria)
(a process of measuring the concentration of a drug in the bloodstream, to avoid excessive levels that might be associated with adverse effects or to ensure adequate levels for therapeutic effect)
(a process of measuring the concentration of a drug in the bloodstream, to avoid excessive levels that might be associated with adverse effects or to ensure adequate levels for therapeutic effect)
(the level of gentamicin in the baby's bloodstream shortly before a further dose is given; high trough gentamicin concentrations may be associated with an increased risk of adverse effects)

Paths in this pathway

Pathway created: August 2012 Last updated: April 2021

© NICE 2021. All rights reserved. Subject to Notice of rights.

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