Table 1: Information and communication during pregnancy, in labour and after birth

If any clinical concerns about possible early-onset neonatal infection arise during pregnancy or in the first 72 hours after birth (for example, in relation to risk factors or clinical indicators): tell the baby’s parents and/or carers explain the reason for concern (including the nature of early-onset neonatal infection) discuss the preferred options for management (for example, observation, investigations or antibiotic treatment) allow time for the baby’s parents and/or carers to consider the information provided and offer further opportunities for discussion if appropriate. If considering antibiotic treatment because of clinical concerns about possible early-onset neonatal infection, discuss: the rationale for the treatment the risks and benefits in the individual circumstances the observations and investigations that may be needed to guide clinical management (for example, when to stop treatment) the preferred antibiotic regimen and likely duration of treatment the impact, if any, on where the woman and her baby will be cared for. To maintain communication with a woman in labour whose baby is at risk of infection, healthcare professionals should involve the woman in any handover of care, either when additional expertise is brought in because of the risk of infection or during planned changes in staff. The handover should include an update about the presence of any infection. [This recommendation is adapted from recommendation 1.3.2 in ‘Intrapartum care’ (NICE clinical guideline 55)].

Reassure parents or 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.

Reassure parents and carers that babies at risk of or with early-onset neonatal infection can usually continue to breastfeed, and that every effort will be made to facilitate this. If a baby is temporarily unable to breastfeed, support the mother to express breast milk if she wishes to do so.

Table 2: Information for parents and carers of babies with suspected or confirmed early-onset neonatal infection at discharge

Offer parents and carers contact details of patient support organisations that can provide support, befriending, counselling, information and advocacy. They may signpost families to other sources of help. [This recommendation is adapted from recommendation 1.5.2 in ‘Bacterial meningitis and meningococcal septicaemia’ (NICE clinical guideline 102)]. When the baby is discharged from hospital or midwifery-led unit (or in the immediate postnatal period in the case of babies born at home), inform the parents or carers verbally and in writing if the baby is at increased risk of infection. When a baby who has had a Group B streptococcal infection is discharged from hospital: advise the woman that if she becomes pregnant again: - there will be an increased risk of early-onset neonatal infection - she should inform her maternity care team that a previous baby has had a Group B streptococcal infection - antibiotics in labour will be recommended inform the woman’s GP in writing about the risk of Group B streptococcal infection in future pregnancies. If a baby has been treated for suspected or confirmed early-onset neonatal infection: inform the parents or carers about potential long-term effects of the baby’s illness and likely patterns of recovery, including reassurance if no problems are anticipated take account of parental concerns when providing information and planning follow-up. If there have been any concerns about early-onset neonatal infection before a baby is discharged, advise the parents or carers verbally and in writing that they should seek medical help (for example, from NHS Direct or an emergency department, depending on local services) if the baby shows signs of: altered behaviour (for example, inconsolable crying) or responsiveness (for example, listlessness), or being floppy, or developing difficulties with feeding or tolerating feeds, or temperature abnormality unexplained by environmental factors.

Before and during birth

1-Unborn baby Recognise the following as risk factors for early-onset neonatal infection: prelabour rupture of membranes preterm birth (before 37 weeks’ gestation), especially with prelabour rupture of membranes confirmed or suspected chorioamnionitis (for example, because of intrapartum fever) antenatal maternal Group B streptococcal colonisation, bacteriuria or infection invasive Group B streptococcal infection in a previous baby antibiotic treatment given to the mother for confirmed or suspected invasive bacterial infection 24 hours before birth, during labour or within 24 hours after the birth.

2-During labour For women in labour identify and assess any risk factors for earlyonset neonatal infection. Throughout labour monitor for the emergence of new risk factors, such as maternal fever rupture of membranes in preterm labour.

3-Intrapartum prophylaxis Assess whether any of the following risk factors are present

YES

Group B streptococcal colonisation, bacteriuria or infection during the current pregnancy a previous baby affected by invasive Group B streptococcal disease preterm labour with ruptured membranes.

4-Offer intrapartum antibiotic prophylaxis using benzylpenicillin

NO

5-Intrapartum prophylaxis is not indicated

If the woman is allergic to penicillin, offer an alternative antibiotic for intrapartum prophylaxis based on expert microbiological advice and taking account of individual bacterial susceptibility.

6 - Risk assessment after birth (see pathway C – after birth)

After birth 7-If there are any risk factors for early-onset neonatal infection (see Table 3) or if there are reported clinical indicators of possible early-onset neonatal infection (see Table 4) perform a careful clinical assessment without delay.

8- Use the following framework based on risk factors for infection (see Table 3), clinical indicators of possible infection (see Table 4) and ‘red flags’ for infection (see Table 5) to direct clinical actions with regard to starting or withholding antibiotic treatment.

9Any ‘red flag’ risk factors or clinical indicators (see Table 5).

10No ‘red flags’ (see Table 5) Two or more risk factors (see Table 3) or clinical indicators (see Table 4).

13-

12-

11No ‘red flags’ (see Table 5) No clinical indicators (see Table 4) One risk factor (see Table 3).

No ‘red flags’ (see Table 5) No risk factors (see Table 3) One clinical indicator (see Table 4).

15Using clinical judgement, consider withholding antibiotics and monitoring the baby. Monitor the baby closely for clinical indicators of possible infection, including the vital signs. Continue monitoring for at least 12 hours from birth at: o 1 hour o 2 hours o then 2-hourly for 10 hours.

14Perform a blood culture before starting antibiotic treatment. If a decision is made to give antibiotic treatment to the baby it should be started if possible within 30 minutes and always within 1 hour of the decision.

Yes

Clinical indicators of infection develop during monitoring

Babies without risk factors, clinical indicators or laboratory evidence of possible infection.

16-Continue routine postnatal care (see ‘Postnatal care’, NICE clinical guideline 37). Do not routinely give antibiotic treatment.

NO

17For every baby about whom there has been a clinical concern regarding early-onset neonatal infection formulate a safe postdischarge management plan, taking account, for example, of: the level of the initial clinical concern the presence of risk factors parental concerns. Reassure the family. Give information about what to look for.

Table 3 Risk factors for early-onset neonatal infection Prelabour rupture of membranes Preterm birth (before 37 weeks’ gestation), especially with prelabour rupture of membranes Confirmed or suspected chorioamnionitis (for example, because of intrapartum fever) Antenatal maternal Group B streptococcal colonisation, bacteriuria or infection Invasive Group B streptococcal infection in a previous baby Antibiotic treatment given to the mother for confirmed or suspected invasive bacterial infection 24 hours before birth, during labour or within 24 hours after the birth.

Table 4 Clinical indicators of possible early-onset neonatal infection

Altered behaviour or responsiveness Altered muscle tone (for example, floppiness) Feeding difficulties (for example, feed refusal) Feed intolerance, including vomiting or abdominal distension Altered heart rate Signs of respiratory distress Oxygen desaturation Apnoea Signs of perinatal asphyxia or hypoxic ischaemia Seizures Need for cardio-pulmonary resuscitation Need for mechanical ventilation, particularly in a term baby Persistent fetal circulation (persistent pulmonary hypertension) Temperature abnormality unexplained by environmental factors Signs of shock Unexplained bleeding disorders such as thrombocytopenia, excessive bleeding or abnormal coagulation tests (International Normalised Ratio greater than 2.0) Oliguria 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 Confirmed or suspected infection in a co-twin.

Table 5 ‘Red flags’ suggesting a high risk of early-onset neonatal infection:

Systemic antibiotic treatment given to the mother for confirmed or suspected invasive bacterial infection within 24 hours of the birth Seizures in the baby Signs of shock in the baby Need for mechanical ventilation in a term baby Suspected or confirmed infection in a co-twin.

Babies starting antibiotic treatment Suspected early-onset neonatal infection

18Do not perform urine microscopy or culture as part of the investigation for systemic early-onset neonatal infection.

19Perform a blood culture before starting antibiotic treatment in babies with risk factors for infection or clinical indicators of possible infection.

Do not perform skin swab microscopy or culture as part of the investigation for systemic early-onset neonatal infection in the absence of clinical signs of a localised infection.

20If localised infection is suspected see ‘Localised infection’ pathway.

21-

22-

Perform a lumbar puncture to obtain a cerebrospinal fluid sample before starting antibiotics if it is thought safe to do so and: there is a strong clinical suspicion of infection, or there are clinical symptoms or signs suggesting meningitis.

If meningitis is suspected see ‘Suspected or confirmed meningitis’ pathway.

If performing the lumbar puncture would delay starting antibiotics, perform it as soon as possible afterwards.

23Start antibiotic treatment for earlyonset infection without meningitis. (See ‘Antibiotic treatment for earlyonset infection without meningitis’ pathway.)

Antibiotic treatment for early-onset infection without meningitis 24-Start antibiotic treatment

25- Use benzylpenicillin with gentamicin as the first-choice antibiotic regimen for empirical treatment of suspected infection.

26Give benzylpenicillin in a dose of 25 mg/kg every 12 hours. Consider reducing the dosage interval to 6-hourly based on clinical judgement (for example, if the baby appears very ill). Give gentamicin in a starting dose of 4.5 mg/kg. If a second dose of gentamicin is to be given it should usually be given 36 hours after the first dose. The interval may be shortened, based on clinical judgement, for example: o for Gram-negative infections o if the baby appears very ill. Decide on subsequent gentamicin dosages and intervals taking account of blood gentamicin concentrations. Record the times of: o gentamicin administration o sampling for therapeutic monitoring.

27In babies given antibiotics because of risk factors for infection or clinical indicators of possible infection, measure the C-reactive protein concentration: 8-16 hours after presentation, and 18-24 hours after that first measurement.

28Consider performing a lumbar puncture to obtain a cerebrospinal fluid sample in a baby who is receiving antibiotics if it is thought safe to do so and if the baby: has a C-reactive protein concentration of 10 mg/litre or greater, or has a positive blood culture, or has a low white blood cell count or neutrophil count (if these have been measured), or does not respond satisfactorily to antibiotic treatment.

30Regularly reassess the clinical condition and results of investigations in babies receiving antibiotics. Consider whether to change the antibiotic regimen taking account of: clinical judgement (for example, if the baby’s clinical condition is not improving) the results of microbiological investigations expert microbiological advice, taking account of local surveillance data.

29If meningitis is suspected see ‘Suspected or confirmed meningitis’ pathway.

Duration of antibiotic treatment

31In babies given antibiotics because of risk factors for infection or clinical indicators of possible infection consider stopping the antibiotics at 36 hours if: the initial clinical suspicion of infection was not strong, and the C-reactive protein concentration was less than 10 mg/litre on both the 8-16 hour and the follow up 18-24 hour measurements, and the blood culture is negative, and the baby appears well and there are no clinical indicators of possible infection.

32-

33-

The usual duration of antibiotic treatment should be 5 days in babies with any of the following: a strong initial clinical suspicion of infection continued clinical concerns about infection at 36 hours a C-reactive protein concentration of 10 mg/litre or greater on either the 8–16 hour or the follow-up 18–24 hour measurements a positive blood culture.

Using clinical judgement, consider continuing antibiotic treatment for more than 5 days if: the baby has not yet fully recovered, or this is advisable, based on the blood culture result and, if necessary, expert microbiological advice.

Consider stopping antibiotics sooner than 5 days if the initial suspicion was not strong, the baby is well at 36 hours, the C-reactive protein concentration was only slightly elevated and is improving, and the blood culture was negative.

34When deciding on the appropriate care setting for a baby, take into account their clinical needs and the competencies necessary to ensure safe and effective care, for example the insertion and care of intravenous cannulas.

35-

36-

Consider completing a course of antibiotics outside hospital (for example, at home or through visits to a local health centre or standalone midwifery-led unit) in selected babies who are clinically well and have adequate support depending on local circumstances. Clinical criteria for selection of babies should include:

On completing antibiotic treatment, consider prompt discharge of the baby from hospital, with support for the parents or carers and a point of contact for advice.

o o o o o

no complications of the infection, and expected response to antibiotics, and fully feeding according to parental preference, and no support needed to maintain a normal temperature, and no respiratory support needed.

Suspected or confirmed meningitis (babies in neonatal units) 37- Suspected meningitis

38-

39-

40-

41-

If meningitis is suspected because a baby’s cerebrospinal fluid white blood cell count is elevated, but the causative pathogen is unknown because the Gram stain is uninformative, use an antibiotic regimen based on local expert microbiological advice.

If the cerebrospinal fluid glucose or protein concentrations are abnormal but the cerebrospinal fluid white blood cell count is normal and the Gram stain is uninformative: use clinical judgement, paying particular attention to clinical evidence of meningitis, to decide whether to treat for possible meningitis; if treating, use an antibiotic regimen based on local expert microbiological advice review the treatment decision taking account of subsequent cerebrospinal fluid culture results.

If the cerebrospinal fluid Gram stain suggests Group B streptococcal meningitis, give:

If the cerebrospinal fluid Gram stain or culture indicates meningitis with an organism other than Group B streptococcus, use an antibiotic treatment regimen based on local expert microbiological advice.

benzylpenici llin 50 mg/kg every 12 hours and gentamicin 4.5 mg/kg every 36 hours.

42Consider shorter courses of benzylpenicillin in carefully selected babies, such as those who are clinically well and have a normal C-reactive protein concentration within 5 days, and use clinical judgement to decide whether to repeat measurement of C-reactive protein and lumbar puncture. When deciding on the appropriate care setting for a baby, take into account their clinical needs and the competencies necessary to ensure safe and effective care, for example the insertion and care of intravenous cannulas. Consider completing a course of antibiotics outside hospital (for example, at home or through visits to a local health centre or standalone midwiferyled unit) in selected babies who are clinically well and have adequate support depending on local circumstances. Clinical criteria for selection of babies should include: o o o o o

no complications of the infection, and expected response to antibiotics, and fully feeding according to parental preference, and no support needed to maintain a normal temperature, and no respiratory support needed.

On completing antibiotic treatment, consider prompt discharge of the baby from hospital, with support for the parents or carers and a point of contact for advice.

43- Confirmed meningitis In babies in whom the cerebrospinal fluid culture confirms Group B streptococcal meningitis give: benzylpenicillin 50 mg/kg every 12 hours for at least 14 days, and gentamicin 4.5 mg/kg every 36 hours for 5 days.

Localised infections of the eye and umbilical cord 44-Suspected localised infections of the eye or umbilical cord

45-

46-

Be aware that, while minor conjunctivitis with encrusting of the eyelids is common and often benign, a purulent discharge may indicate the presence of a serious infection, for example with chlamydia or gonococcus.

In babies with clinical signs of umbilical infection, including a purulent discharge or signs of periumbilical cellulitis (for example, redness, increased skin warmth or swelling) perform a blood culture and a swab sample for microscopy and culture, and

47In babies with a purulent eye discharge collect swab samples urgently for microscopy and culture, specifically looking for chlamydia and gonococcus. Start systemic antibiotic treatment to cover for possible gonococcal infection while awaiting the microbiology results.

start intravenous antibiotic treatment with flucloxacillin (62.5–125 mg every 6 hours) and gentamicin (starting dose 4.5 mg/kg).

Therapeutic drug monitoring for gentamicin Start antibiotic treatment 48-First mg/kg)

dose

of

gentamicin

(4.5

49If a second dose of gentamicin is to be given measure the trough blood gentamicin concentration immediately before giving the second dose.

36 hours after starting antibiotic treatment

50- Second dose of gentamicin If a second dose of gentamicin is to be given it should usually be given 36 hours after the first dose. The interval may be shortened, based on clinical judgement, for example:

Record the times of: o gentamicin administration o sampling for therapeutic monitoring.

for Gram-negative infections if the baby appears very ill.

51-Trough concentrations If a second dose of gentamicin is to be given measure the trough blood gentamicin concentration immediately before giving the second dose. Consider the trough concentration before giving a third dose of gentamicin. Adjust the gentamicin dosage interval, aiming to achieve trough concentrations of less than 2 mg/litre. If the course of gentamicin lasts more than three doses a trough concentration of less than 1 mg/litre is advised. If an intended trough concentration measurement is not available do not withhold the next dose of gentamicin. Consider repeating the measurement of trough concentrations immediately before every 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 within 36 hours of sampling.

52- Peak concentrations Consider measuring peak blood gentamicin concentrations in selected babies, for example in babies: o with oedema o with macrosomia (birthweight more than 4.5 kg) o who do not respond to treatment. Measure peak concentrations 1 hour after starting the gentamicin infusion. Consider increasing the dose of gentamicin if the peak concentration is less than 8 mg/litre.