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National Collaborating Centre for Women's and Children's Health (UK). Antibiotics for Early-Onset Neonatal Infection: Antibiotics for the Prevention and Treatment of Early-Onset Neonatal Infection. London: RCOG Press; 2012 Aug. (NICE Clinical Guidelines, No. 149.)

12Care setting

Introduction

The objectives of this review question are to evaluate the impact of care setting on the clinical management of early-onset neonatal infection. The guideline development group’s (GDG’s) considerations in relation to this question were intended to encompass the woman’s choice of care setting, subject to constraints imposed by the guideline scope, existing NICE guidance for maternity care (see below) and the feasibility of delivering a safe standard of care in different settings (predominantly primary care, including community care, or secondary care). A systematic search for evidence was conducted with no restrictions on study design and explicitly seeking to identify qualitative research reporting views and experiences of parents and carers of babies with or at risk of early-onset neonatal infection and discrete choice experiments to elicit their preferences in relation to options for clinical management. The GDG drew on evidence identified for other review questions in terms of settings where care was delivered. Additionally, the GDG considered competencies needed to deliver the level of care specified in recommendations in other sections of the guideline.

Review question

How does the choice of care setting impact on the clinical management of early-onset neonatal infection?

Existing NICE guidance

Intrapartum care (NICE clinical guideline 55, 2007) includes review questions and recommendations relating to place of care. In particular, it includes a review question on risk factors to be included in assessment to determine the most appropriate place of birth for women during pregnancy. The guideline recommendations identify several groups of women with medical conditions indicating increased risk that suggests planned birth at an obstetric unit: one such group is women with risk factors associated with GBS such that antibiotics in labour would be recommended.

The guideline identified prelabour rupture of membranes (PROM) as a major obstetric risk factor for neonatal infection (although preterm PROM was excluded from the scope of the guideline). The guideline evaluated various clinical management strategies following term PROM, including consideration of the following issues:

  • place of care before and during labour and birth
  • routine admission to a neonatal unit after birth.

Expectant management at home (rather than expectant management as a hospital inpatient) was identified as a risk factor for neonatal infection after term PROM. The guideline recommended a risk-based clinical management strategy for women with term PROM, which included the following elements.

  • Induction of labour is appropriate approximately 24 hours after rupture of the membranes.
  • Advise women that, if labour has not started 24 hours after rupture of the membranes, they should give birth in a healthcare setting with access to neonatal services and stay in hospital for at least 12 hours after the birth so that the baby can be observed.
  • Offer immediate referral to a neonatal care specialist for a baby with any symptom of possible sepsis, or born to a woman who has evidence of chorioamnionitis.

The guideline also includes review questions on labouring and giving birth in water, and these questions specifically consider the risk of maternal and neonatal infections (meaning that consideration of these issues is outside the scope of this guideline).

Induction of labour (NICE clinical guideline 70, 2008) recommends that if a woman has preterm PROM after 34 weeks, the maternity team should discuss the local availability of neonatal intensive care facilities with her before a decision is made about whether to induce labour.

Postnatal care (NICE clinical guideline 37, 2006) includes the following recommendations relating to care setting:

  • Length of stay in a maternity unit should be discussed between the individual woman and her healthcare professional, taking account of the health and wellbeing of the woman and her baby and the level of support available after discharge.
  • Local protocols for written communication, particularly in relation to transfer of care between clinical sectors and healthcare professionals, should be available and audited.
  • Breastfeeding support should be made available regardless of the location of care.
  • Offer parents information and advice at each postnatal contact to allow them to assess their baby’s general condition, identify symptoms and signs of common infant health problems, and contact healthcare professionals or emergency medical services if needed.

Bacterial meningitis and meningococcal septicaemia (NICE clinical guideline 102, 2010) includes the following recommendations relating to care setting (although babies who are already receiving care in neonatal units are excluded from the guideline):

  • Recognise shock in babies who present with symptoms and signs of bacterial meningitis or meningococcal septicaemia and manage urgently in secondary care.
  • Transfer babies with suspected bacterial meningitis or suspected meningococcal septicaemia to secondary care as an emergency by telephoning 999.
  • Transfer to tertiary care should be undertaken by an experienced paediatric intensive care retrieval team comprising medical and nursing staff.
  • Before discharging babies from hospital consider their requirements for follow-up and discuss potential long-term effects of their condition and likely patterns of recovery with their parents or carers.
  • Inform the baby’s health visitor about their bacterial meningitis or meningococcal septicaemia.

Feverish illness in children (NICE clinical guideline 47, 2007) includes the following recommendations about care setting:

  • Offer immediate referral for emergency medical care using the most appropriate means of transport (usually 999 ambulance) for babies with an immediately life-threatening illness (this recommendation is reiterated in Urinary tract infection in children, NICE clinical guideline 54, 2007).
  • Offer urgent referral to a paediatric specialist for babies with a high risk of serious illness but no immediately life-threatening illness (this recommendation is reiterated in Urinary tract infection in children, NICE clinical guideline 54, 2007).
  • Offer urgent review by an experienced paediatrician for babies with fever and shock who cannot be roused or show clinical signs of meningococcal disease and consider offering referral to paediatric intensive care.
  • Provide a ‘safety net’ for babies with an intermediate risk of serious illness and for whom no diagnosis has been made, or offer referral to specialist paediatric care for further assessment (safety netting means giving the baby’s parent or carers verbal or written information on warning symptoms and how to access further health care, arranging follow-up at a specific time and location, or liaising with other healthcare professionals, including out-of-hours providers, to ensure direct access for the baby if further assessment is needed).

The guideline recommends home-based care for babies with a low risk of serious illness and offering the baby’s parents or carers advice on when and how to seek further advice and care from healthcare professionals. The guideline also recommends consideration of social and family circumstances and parental anxiety and instinct when deciding whether or not to admit a baby with fever to hospital.

Description of included studies

One prospective, non-comparative observational study was identified for inclusion for this review question (Wagner 2000). The study reported cure rate and other infant outcomes in babies who had received antibiotics in hospital for early-onset neonatal sepsis and who were considered suitable for early discharge with continuation of parenteral antibiotics as outpatients. Early discharge was defined as discharge after at least 4 days of inpatient antibiotic treatment for babies with suspected or proven sepsis or pneumonia (n=83) and after at least 10 days of inpatient antibiotic treatment for babies with meningitis (n=1): in both groups of babies clinical status had to have normalised for at least 48 hours before discharge. All babies included in the study had been prescribed at least a 7–10 day course of antibiotics, implying that completion of the course after early discharge would typically require at least another 3–6 days of outpatient antibiotic treatment. Outpatient administration of antibiotics was performed at the baby’s home or in the primary care doctor’s surgery by a nurse with paediatric training. Consideration for outpatient treatment was contingent on the parents having access to a telephone at home and transport being readily available in case of emergency.

Before discharge parents were given information on care of the intravenous site (for example, how to evaluate the patency of an intravenous catheter and how to flush the catheter with heparin or saline every 8 hours) and how to recognise symptoms and signs of septic shock, anaphylaxis and change in respiratory status. Each baby was examined daily by the visiting nurse or primary care doctor to check for changes in clinical course, and an anaphylaxis epinephrine kit was placed at the baby’s bedside by the visiting nurse at the first home visit. Most (56%) of the babies received ampicillin plus gentamicin: other antibiotic regimens involved ceftriaxone (21%), ampicillin alone (11%), benzylpenicillin alone (9%), gentamicin alone (1%) or nafcillin (2%). When ceftriaxone was prescribed before discharge the first dose was given as an inpatient to monitor for allergic reactions. Four babies who were prescribed intravenous ampicillin plus gentamicin before discharge had their antibiotic regimen changed to intramuscular ceftriaxone after discharge because of loss of intravenous access; in such cases the visiting nurse observed the baby for 1 hour after administration of the first dose of ceftriaxone. For babies prescribed gentamicin, peak and trough levels were measured before discharge and follow-up levels were measured if necessary to ensure blood serum levels were in the therapeutic range.

Evidence profiles

The evidence profile for this review question is presented in Table 12.1.

Table 12.1. Evidence profile for parenteral antibiotic treatment at home after hospital inpatient treatment in babies with suspected or confirmed early-onset neonatal infection.

Table 12.1

Evidence profile for parenteral antibiotic treatment at home after hospital inpatient treatment in babies with suspected or confirmed early-onset neonatal infection.

Evidence statements

No cases of treatment failure or re-admission to hospital during home antibiotic treatment because of worsening clinical course or hyperbilirubinaemia were reported in babies with early-onset neonatal infection who were discharged to parenteral (intravenous or intramuscular) antibiotic treatment after their clinical status had normalised for at least 48 hours and they had received antibiotics in hospital for at least 4 days in the case of culture-proven sepsis, clinical sepsis and pneumonia, or at least 10 days in the case of meningitis (very low quality evidence). Two babies were, however, re-admitted to hospital during home antibiotic treatment because the mother or primary care doctor withdrew from the study (very low quality evidence). A further two babies were re-admitted to hospital within 6months of completing the course of antibiotics at home (one because of unspecified abdominal pain at age 2 weeks and an unspecified acute viral infection at age 5 weeks, and the other because of a diagnosis of viral enteritis at age 6 weeks; very low quality evidence).

Health economics profile

The GDG planned to conduct a cost effectiveness analysis comparing different strategies for identifying and treating babies at risk of early-onset neonatal infection or with symptoms and signs of early-onset neonatal infection, including different care settings. However, no published health economic analyses were identified relating to this review question, and no clinical evidence was identified to inform development of a health economic model specifically for the guideline.

Evidence to recommendations

Relative value placed on the outcomes considered

All the outcomes specified in the review protocol for this question (cure rates for neonatal infection, mortality, duration of hospital stay, neonatal adverse events, long-term outcomes and resistance among neonatal flora), were considered by the GDG to be influential in the formulation of recommendations. While mortality and long-term outcomes were recognised as being critical to the formulation of recommendations, the GDG did not formally agree an order of priority for the remaining outcomes.

The GDG considered various definitions of cure rate that might be relevant, and agreed that the following would all be relevant:

  • mortality
  • culture-positive cases that become culture-negative
  • culture-positive cases who have recovered (clinically better or resolution of laboratory abnormalities) without need for changing antibiotics
  • composite of culture-positive and culture-negative cases who have been treated for at least 5 days and have recovered (clinically better or resolution of laboratory abnormalities) without need for changing antibiotics.

Consideration of clinical benefits and harms

The potential benefit identified by the GDG in delivering care outside the hospital setting (while maintaining a safe standard of care) would be to give more choice in terms of care setting to pregnant women whose unborn babies are at risk of an early-onset neonatal infection and their families (for example home birth attended by community midwives or birth in a midwife-led unit). Similar considerations could result in shorter hospital stays for babies at risk of early-onset neonatal infection if they could safely be observed at home, and for babies with suspected or confirmed early-onset neonatal infection for whom antibiotic treatment can safely be concluded at home. Both scenarios would be beneficial, especially for those parents and carers who might live far from a hospital where their baby is being treated, and it would avoid separating families for long periods.

The GDG was aware that in the UK there is an increasing tendency for children and adults with infection to be discharged from hospital before the end of antibiotic treatment, allowing treatment to be completed at home (in the community antibiotics can be administered by a community nurse). The GDG emphasised as a potential harm the fact that some community services might not be able to provide a necessarily safe standard level of care. Moreover, some parents and carers might not be able to care for a baby at home, or they might feel more reassured if the baby received care in a hospital setting.

Consideration of net health benefits and resource use

The GDG planned to conduct a cost effectiveness analysis to evaluate the impact of care setting on resource use in the management of early-onset neonatal infection. However, no published health economic analyses were identified, and no clinical evidence was identified to inform the development of a health economic model for this question. The GDG recommended further research to evaluate the clinical and cost effectiveness of different models of care for the prevention and treatment of early-onset neonatal infection.

Quality of evidence

Only one study was identified for inclusion and the evidence it contributed was of very low quality. The GDG therefore included a weak recommendation stating that healthcare professionals should consider completing a course of antibiotics outside hospital (for example at home or through visits to a standalone midwifery-led unit) in carefully selected babies depending on the support available locally. In the absence of any evidence at all to direct recommendations with regard to other aspects of care according to the healthcare setting in which it is delivered, the GDG used consensus based on the group members’ experience as clinicians or parents or carers.

Other considerations

The GDG agreed that it is important that parents and carers be given appropriate information before the woman and/or baby is discharged from hospital, and that they should have the opportunity to discuss with their healthcare professionals the setting in which care of the baby is delivered before making decisions (see Chapter 1). Another issue discussed by the GDG was the fact that if babies continue antibiotic treatment at home there might be the need for recannulation and the GDG highlighted the risks associated with this procedure.

Key conclusions

As outlined above, the GDG’s considerations regarding the very low quality evidence for completing a course of antibiotics outside hospital led to a weak recommendation to consider completing a course of antibiotics outside hospital (for example at home or through visits to a standalone midwifery-led unit) in carefully selected babies (specifically in well babies with no ongoing concerns) provided appropriate support is available locally. The GDG discussed the fact that some babies might also need blood tests to be performed as part of therapeutic drug monitoring and that this should be taken into consideration when completion of a course of antibiotics at home is being considered.

Due to the lack of other evidence identified for this review question, the GDG agreed that the setting where care of the baby is delivered should be determined by the baby’s clinical needs and the competencies needed to deliver the care recommended elsewhere in the guideline. The GDG proposed that specific competencies should be established for the following groups of babies, although no direct evidence to inform the specification of relevant competencies was identified:

  • babies with no risk factors for infection
  • babies who have risk factors for infection but have not yet received antibiotics (including babies whose mothers had intrapartum antibiotics and those in whom intrapartum antibiotics were indicated but not received)
  • babies who are asymptomatic at the time of starting antibiotics
  • babies who have symptoms or signs of infection at the time of starting antibiotics
  • critically ill babies (that is, those requiring organ support, such as ventilation, and those in critical care settings [babies in intensive care and high dependency care, rather than those in special care or transitional care])
  • clinically well babies who are still receiving antibiotics
  • babies who are being observed after completion of antibiotics.

The GDG recognised that care setting for the woman in terms of planning place of birth is covered by Intrapartum care, (NICE clinical guideline 55, 2007) and is therefore outside the scope of this guideline.

Recommendations

NumberRecommendation
Care setting
70Using 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 without ongoing concerns if there is adequate local support.
71When deciding on the appropriate care setting for a baby, take into account the baby’s clinical needs and the competencies necessary to ensure safe and effective care (for example, the insertion and care of intravenous cannulas).

Research recommendations

NumberResearch recommendation
Care setting
RR 14What is the clinical and cost effectiveness of different models of care for the prevention and treatment of early-onset neonatal infection?

Why this is important
The systematic reviews conducted for the guideline identified very limited evidence in relation to care setting. Further research is needed to evaluate the clinical and cost effectiveness of different models of care for the prevention and treatment of early-onset neonatal infection. This is important because of the need to support informed choice relating to care setting during labour, birth and the postnatal period. The research should include consideration of the competencies required to deliver particular aspects of care (such as intrapartum antibiotic prophylaxis), the implications of transfer between different care settings (such as transfers to or from the woman’s home or a stand-alone midwifery unit), and family preferences, including the balance between choice and safety. The models of care should be specified, including exposure to medication. The potential benefits and harms of each component should be considered as part of the evaluation of clinical and cost effectiveness.
Copyright © 2012, National Collaborating Centre for Women’s and Children’s Health.

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Cover of Antibiotics for Early-Onset Neonatal Infection
Antibiotics for Early-Onset Neonatal Infection: Antibiotics for the Prevention and Treatment of Early-Onset Neonatal Infection.
NICE Clinical Guidelines, No. 149.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2012 Aug.

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