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Antibiotics for early-onset neonatal infection HAI

About

What is covered

This pathway covers antibiotics for the prevention and treatment of early-onset neonatal infection.
Early-onset neonatal bacterial infection (infection with onset within 72 hours of birth) is a significant cause of mortality and morbidity in newborn babies. Parent organisations and the scientific literature report that there can be unnecessary delays in recognising and treating sick babies. In addition, concern about the possibility of early-onset neonatal infection is common. This concern is an important influence on the care given to pregnant women and newborn babies. There is wide variation in how risk of infection is managed in healthy babies. The approach taken by the NHS needs to:
  • prioritise the treatment of sick babies
  • minimise the impact of management pathways on healthy women and babies
  • use antibiotics wisely to avoid the development of resistance to antibiotics.
These drivers have not always been addressed consistently in the NHS, and the antibiotics for early-onset neonatal infection guideline was commissioned to ensure they would be addressed in future.
Five key principles underpin the recommendations in this guideline.
  • Unless it is dangerous, families should be offered choice. The guideline includes recommendations to support families in making choices through provision of information and, where appropriate, reassurance.
  • Intrapartum antibiotic prophylaxis should be administered in a timely manner to all eligible women who choose it.
  • Babies with suspected early-onset neonatal infection should be treated as quickly as possible.
  • Antibiotic exposure should be minimised in babies who do not have an early-onset neonatal infection.
  • An integrated system of clinical care is needed to allow full implementation of the guideline recommendations.

Updates

Updates to this pathway

17 December 2014 Antibiotics for neonatal infection (NICE quality standard 75) added to this pathway.
2 December 2014 Minor maintenance updates.
29 August 2014 Minor maintenance updates.
24 June 2014 Minor maintenance updates.
6 November 2013 Minor maintenance updates.
26 February 2013 Minor maintenance updates.
4 January 2013 Minor maintenance updates.
5 September 2012 Minor maintenance updates.
24 August 2012 Podcast added.

Patient-centred care

Patients and healthcare professionals have rights and responsibilities as set out in the NHS Constitution for England – all NICE guidance is written to reflect these. Treatment and care should take into account individual needs and preferences. People should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. If the person is under 16, their family or carers should also be given information and support to help the child or young person to make decisions about their treatment. Healthcare professionals should follow the Department of Health's advice on consent. If someone does not have capacity to make decisions, healthcare professionals should follow the code of practice that accompanies the Mental Capacity Act and the supplementary code of practice on deprivation of liberty safeguards.
For young people moving between paediatric and adult services, care should be planned and managed according to the best practice guidance described in the Department of Health’s Transition: getting it right for young people.
Adult and paediatric healthcare teams should work jointly to provide assessment and services to young people. Diagnosis and management should be reviewed throughout the transition process, and there should be clarity about who is the lead clinician to ensure continuity of care.

Short Text

Antibiotics for the prevention and treatment of early-onset neonatal infection

What is covered

This pathway covers antibiotics for the prevention and treatment of early-onset neonatal infection.
Early-onset neonatal bacterial infection (infection with onset within 72 hours of birth) is a significant cause of mortality and morbidity in newborn babies. Parent organisations and the scientific literature report that there can be unnecessary delays in recognising and treating sick babies. In addition, concern about the possibility of early-onset neonatal infection is common. This concern is an important influence on the care given to pregnant women and newborn babies. There is wide variation in how risk of infection is managed in healthy babies. The approach taken by the NHS needs to:
  • prioritise the treatment of sick babies
  • minimise the impact of management pathways on healthy women and babies
  • use antibiotics wisely to avoid the development of resistance to antibiotics.
These drivers have not always been addressed consistently in the NHS, and the antibiotics for early-onset neonatal infection guideline was commissioned to ensure they would be addressed in future.
Five key principles underpin the recommendations in this guideline.
  • Unless it is dangerous, families should be offered choice. The guideline includes recommendations to support families in making choices through provision of information and, where appropriate, reassurance.
  • Intrapartum antibiotic prophylaxis should be administered in a timely manner to all eligible women who choose it.
  • Babies with suspected early-onset neonatal infection should be treated as quickly as possible.
  • Antibiotic exposure should be minimised in babies who do not have an early-onset neonatal infection.
  • An integrated system of clinical care is needed to allow full implementation of the guideline recommendations.

Updates

Updates to this pathway

17 December 2014 Antibiotics for neonatal infection (NICE quality standard 75) added to this pathway.
2 December 2014 Minor maintenance updates.
29 August 2014 Minor maintenance updates.
24 June 2014 Minor maintenance updates.
6 November 2013 Minor maintenance updates.
26 February 2013 Minor maintenance updates.
4 January 2013 Minor maintenance updates.
5 September 2012 Minor maintenance updates.
24 August 2012 Podcast added.

Sources

NICE guidance

The NICE guidance that was used to create the pathway.

Quality standards

Quality statements

Intrapartum antibiotics

This quality statement is taken from the antibiotics for neonatal infection quality standard. The quality standard defines clinical best practice in antibiotics for neonatal infection care 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. Data can be collected using NICE’s intrapartum antibiotics clinical audit tool, audit standards 1 and 2.
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. Data can be collected using NICE’s intrapartum antibiotics clinical audit tool, audit standard 3a, which includes a note on potential timeframes for audit purposes.
Outcome
Rates of early-onset neonatal infection.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

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 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.

What the quality statement means for patients, service users and carers

Pregnant women who had a previous baby with an infection called group B Streptococcus, or whose tests during this pregnancy show group B Streptococcus bacteria in their bodies, 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
Antibiotics for early-onset neonatal infection (NICE guideline CG149) recommendation 1.3.1.2 states that if a woman decides to take intrapartum antibiotic prophylaxis, the first dose should be given as soon as possible. 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. [Adapted from NICE’s intrapartum antibiotics clinical audit tool, audit standard 3a]
Babies who are at risk of early-onset neonatal infection
Babies are at risk of early-onset neonatal infection if the mother has had a previous baby with an invasive group B streptococcal infection, or has group B streptococcal colonisation, bacteriuria or infection in the current pregnancy. [Adapted from Antibiotics for early-onset neonatal infection (NICE guideline CG149) recommendation 1.3.1.1]
Intrapartum antibiotic prophylaxis
Intravenous benzylpenicillin is given during labour, starting as soon as possible after labour has begun, and is continued until the baby is born.
For women who have an allergy to penicillin, clindamycin is used, unless individual group B streptococcus sensitivity results or local microbiological surveillance data indicate a different antibiotic. [Adapted from Antibiotics for early-onset neonatal infection (NICE guideline CG149) recommendations 1.3.1.2 and 1.3.1.5, and Group B streptococcal disease, early-onset (green-top guideline no. 36) (Royal College of Obstetricians and Gynaecologists)]

Clinical assessment for early-onset neonatal infection

This quality statement is taken from the antibiotics for neonatal infection quality standard. The quality standard defines clinical best practice in antibiotics for neonatal infection care 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 service providers, healthcare professionals and commissioners

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 monitor for risk factors and clinical indicators of early-onset neonatal infection and perform an immediate a 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.

What the quality statement means for patients, service users and carers

Mothers and their 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. Risk factors and clinical indicators below marked [red flag] prompt a high level of concern.
Risk factors
  • invasive group B streptococcal infection in a previous baby
  • maternal group B streptococcal colonisation, bacteriuria or infection in the current pregnancy
  • prelabour rupture of membranes
  • preterm birth following spontaneous labour (before 37 weeks’ gestation)
  • suspected or confirmed rupture of membranes for more than 18 hours in a preterm birth
  • intrapartum fever higher than 38°C, or confirmed or suspected chorioamnionitis
  • parenteral antibiotic treatment given to the woman for confirmed or suspected invasive bacterial infection (such as septicaemia) at any time during labour, or in the 24-hour periods before and after the birth (this does not refer to intrapartum antibiotic prophylaxis) [red flag]
  • suspected or confirmed infection in another baby in the case of a multiple pregnancy [red flag].
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
  • respiratory distress starting more than 4 hours after birth [red flag]
  • hypoxia (for example, central cyanosis or reduced oxygen saturation level)
  • jaundice within 24 hours of birth
  • apnoea
  • signs of neonatal encephalopathy
  • seizures [red flag]
  • need for cardiopulmonary resuscitation
  • need for mechanical ventilation in a preterm baby
  • need for mechanical ventilation in a term baby [red flag]
  • persistent fetal circulation (persistent pulmonary hypertension)
  • temperature abnormality (lower than 36°C or higher than 38°C) unexplained by environmental factors
  • signs of shock [red flag]
  • unexplained excessive bleeding, thrombocytopenia, or abnormal coagulation (international normalised ratio greater than 2.0)
  • oliguria persisting beyond 24 hours after birth
  • altered glucose homeostasis (hypoglycaemia or hyperglycaemia)
  • metabolic acidosis (base deficit of 10 mmol/litre or greater)
  • local signs of infection (for example, affecting the skin or eye).
[Adapted from Antibiotics for early-onset neonatal infection (NICE guideline CG149) recommendation 1.2.3.1]
Newborn babies
Babies under 72 hours old. [Adapted from Antibiotics for early-onset neonatal infection (NICE guideline CG149)]

Prompt antibiotic treatment for early-onset neonatal infection

This quality statement is taken from the antibiotics for neonatal infection quality standard. The quality standard defines clinical best practice in antibiotics for neonatal infection care 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. Data can be collected using NICE’s empirical treatment of suspected infection clinical audit tool, audit standard 3.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (maternity care services) develop protocols to ensure that healthcare professionals give antibiotic treatment within 1 hour of the decision to treat.
Healthcare professionals adhere to protocols for antibiotic treatment 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.

What the quality statement means for patients, service users and carers

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 Antibiotics for early-onset neonatal infection (NICE guideline CG149)]
Newborn babies who need antibiotic treatment
Babies with 2 or more of the risk factors listed below, and babies with any risk factor marked [red flag].
Risk factors
  • invasive group B streptococcal infection in a previous baby
  • maternal group B streptococcal colonisation, bacteriuria or infection in the current pregnancy
  • pre-labour rupture of membranes
  • preterm birth following spontaneous labour (before 37 weeks’ gestation)
  • suspected or confirmed rupture of membranes for more than 18 hours in a preterm birth
  • intrapartum fever higher than 38°C, or confirmed or suspected chorioamnionitis
  • parenteral antibiotic treatment given to the woman for confirmed or suspected invasive bacterial infection (such as septicaemia) at any time during labour, or in the 24-hour periods before and after the birth (this does not refer to intrapartum antibiotic prophylaxis) [red flag]
  • suspected or confirmed infection in another baby in the case of a multiple pregnancy [red flag].
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
  • respiratory distress starting more than 4 hours after birth [red flag]
  • hypoxia (for example, central cyanosis or reduced oxygen saturation level)
  • jaundice within 24 hours of birth
  • apnoea
  • signs of neonatal encephalopathy
  • seizures [red flag]
  • need for cardiopulmonary resuscitation
  • need for mechanical ventilation in a preterm baby
  • need for mechanical ventilation in a term baby [red flag]
  • persistent fetal circulation (persistent pulmonary hypertension)
  • temperature abnormality (lower than 36°C or higher than 38°C) unexplained by environmental factors
  • signs of shock [red flag]
  • unexplained excessive bleeding, thrombocytopenia, or abnormal coagulation (international normalised ratio greater than 2.0)
  • oliguria persisting beyond 24 hours after birth
  • altered glucose homeostasis (hypoglycaemia or hyperglycaemia)
  • metabolic acidosis (base deficit of 10 mmol/litre or greater)
  • local signs of infection (for example, affecting the skin or eye).
[Adapted from Antibiotics for early-onset neonatal infection (NICE guideline CG149) recommendation 1.2.3.2]

Reassessing antibiotic treatment for early-onset neonatal infection

This quality statement is taken from the antibiotics for neonatal infection quality standard. The quality standard defines clinical best practice in antibiotics for neonatal infection care 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 service providers, healthcare professionals and commissioners

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 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.

What the quality statement means for patients, service users and carers

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 Antibiotics for early-onset neonatal infection (NICE guideline CG149)]
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 guideline CG149, recommendation 1.7.2.1]
Hospitals should consider establishing systems to provide blood culture results 36 hours after starting antibiotic treatment to facilitate the timely discontinuation of treatment. [Adapted from Antibiotics for early-onset neonatal infection (NICE guideline CG149) recommendation 1.7.2.2]

Information and support for identification of neonatal infection

This quality statement is taken from the antibiotics for neonatal infection quality standard. The quality standard defines clinical best practice in antibiotics for neonatal infection care 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 service providers, healthcare professionals and commissioners

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 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.

What the quality statement means for patients, service users and carers

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. Items marked [red flag] prompt a high level of concern.
Risk factors
  • invasive group B streptococcal infection in a previous baby
  • maternal group B streptococcal colonisation, bacteriuria or infection in the current pregnancy
  • prelabour rupture of membranes
  • preterm birth following spontaneous labour (before 37 weeks’ gestation)
  • suspected or confirmed rupture of membranes for more than 18 hours in a preterm birth
  • intrapartum fever higher than 38°C, or confirmed or suspected chorioamnionitis
  • parenteral antibiotic treatment given to the woman for confirmed or suspected invasive bacterial infection (such as septicaemia) at any time during labour, or in the 24-hour periods before and after the birth (this does not refer to intrapartum antibiotic prophylaxis) [red flag]
  • suspected or confirmed infection in another baby in the case of a multiple pregnancy [red flag].
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
  • respiratory distress starting more than 4 hours after birth [red flag]
  • hypoxia (for example, central cyanosis or reduced oxygen saturation level)
  • jaundice within 24 hours of birth
  • apnoea
  • signs of neonatal encephalopathy
  • seizures [red flag]
  • need for cardiopulmonary resuscitation
  • need for mechanical ventilation in a preterm baby
  • need for mechanical ventilation in a term baby [red flag]
  • persistent fetal circulation (persistent pulmonary hypertension)
  • temperature abnormality (lower than 36°C or higher than 38°C) unexplained by environmental factors
  • signs of shock [red flag]
  • unexplained excessive bleeding, thrombocytopenia, or abnormal coagulation (international normalised ratio greater than 2.0)
  • oliguria persisting beyond 24 hours after birth
  • altered glucose homeostasis (hypoglycaemia or hyperglycaemia)
  • metabolic acidosis (base deficit of 10 mmol/litre or greater)
  • local signs of infection (for example, affecting the skin or eye).
[Adapted from Antibiotics for early-onset neonatal infection (NICE guideline CG149) recommendation 1.1.1.1]
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. [Adapted from Antibiotics for early-onset neonatal infection (NICE guideline CG149) recommendation 1.1.1.9].
Information about neonatal infection
Verbal and written information for parents and carers that they should seek medical advice (for example, from NHS Direct, 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 developed difficulties with feeding or with tolerating feeds or
  • has an abnormal temperature unexplained by environmental factors (lower than 36°C or higher than 38°C) or
  • has rapid breathing or
  • has a change in skin colour.
[Antibiotics for early-onset neonatal infection (NICE guideline CG149) recommendation 1.1.1.8]

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 antibiotics for neonatal infection quality standard. The quality standard defines clinical best practice in antibiotics for neonatal infection care and should be read in full.

What is a placeholder statement?

A placeholder statement is an area of care that has been prioritised by the Quality Standards Advisory Committee but for which no source guidance is currently available. A placeholder statement indicates 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. Guidance 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.

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Implementation

Commissioning

These resources include support for commissioners to plan for costs and savings of guidance implementation and meeting quality standards where they apply.
These resources will help to inform discussions with providers about the development of services and may include measurement and action planning tools.

Education and learning

NICE produces resources for individual practitioners, teams and those with a role in education to help improve and assess users' knowledge of relevant NICE guidance and its application in practice.

Information for the public

NICE produces information for the public that summarises, in plain English, the recommendations that NICE makes to healthcare and other professionals.
NICE has written information for the public explaining its guidance on each of the following topics.

Pathway information

Patient-centred care

Patients and healthcare professionals have rights and responsibilities as set out in the NHS Constitution for England – all NICE guidance is written to reflect these. Treatment and care should take into account individual needs and preferences. People should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. If the person is under 16, their family or carers should also be given information and support to help the child or young person to make decisions about their treatment. Healthcare professionals should follow the Department of Health's advice on consent. If someone does not have capacity to make decisions, healthcare professionals should follow the code of practice that accompanies the Mental Capacity Act and the supplementary code of practice on deprivation of liberty safeguards.
For young people moving between paediatric and adult services, care should be planned and managed according to the best practice guidance described in the Department of Health’s Transition: getting it right for young people.
Adult and paediatric healthcare teams should work jointly to provide assessment and services to young people. Diagnosis and management should be reviewed throughout the transition process, and there should be clarity about who is the lead clinician to ensure continuity of care.

Supporting information

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

Risk factor
Red flag
Invasive group B streptococcal infection in a previous baby
Maternal group B streptococcal colonisation, bacteriuria or infection in the current pregnancy
Prelabour rupture of membranes
Preterm birth following spontaneous labour (before 37 weeks' gestation)
Suspected or confirmed rupture of membranes for more than 18 hours in a preterm birth
Intrapartum fever higher than 38°C, or confirmed or suspected chorioamnionitis
Parenteral antibiotic treatment given to the woman for confirmed or suspected invasive bacterial infection (such as septicaemia) at any time during labour, or in the 24-hour periods before and after the birth [This does not refer to intrapartum antibiotic prophylaxis]
Yes
Suspected or confirmed infection in another baby in the case of a multiple pregnancy
Yes

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

Clinical indicator
Red flag
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
Respiratory distress starting more than 4 hours after birth
Yes
Hypoxia (for example, central cyanosis or reduced oxygen saturation level)
Jaundice within 24 hours of birth
Apnoea
Signs of neonatal encephalopathy
Seizures
Yes
Need for cardio–pulmonary resuscitation
Need for mechanical ventilation in a preterm baby
Need for mechanical ventilation in a term baby
Yes
Persistent fetal circulation (persistent pulmonary hypertension)
Temperature abnormality (lower than 36°C or higher than 38°C) unexplained by environmental factors
Signs of shock
Yes
Unexplained excessive bleeding, thrombocytopenia, or abnormal coagulation (International Normalised Ratio greater than 2.0)
Oliguria persisting beyond 24 hours after birth
Altered glucose homeostasis (hypoglycaemia or hyperglycaemia)
Metabolic acidosis (base deficit of 10 mmol/litre or greater)
Local signs of infection (for example, affecting the skin or eye)

Glossary

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 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.

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Pathway created: August 2012 Last updated: December 2014

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