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Antibiotics for Early-Onset Neonatal Infection: Antibiotics for the Prevention and Treatment of Early-Onset Neonatal Infection

Antibiotics for Early-Onset Neonatal Infection: Antibiotics for the Prevention and Treatment of Early-Onset Neonatal Infection

NICE Clinical Guidelines - National Collaborating Centre for Women's and Children's Health (UK)

Version: August 2012

Intrapartum antibiotics

The objectives of this review question are to evaluate the effectiveness of antibiotic prophylaxis offered to pregnant women at or shortly before the expected time of labour and birth for the prevention of early-onset neonatal infection. The guideline development group (GDG) used the terminology ‘intrapartum antibiotic prophylaxis’ in its discussions and recommendations, although the question includes consideration of the effectiveness of antibiotic administration shortly before labour starts (for example in women with preterm prelabour rupture of membranes [PROM]). Specific issues prioritised by the GDG for consideration in this question were: the effectiveness of antibiotic prophylaxis compared to no treatment; which class of antibiotics (narrow- or broad-spectrum) to use for prophylaxis; timing, route and frequency of antibiotic administration; and dosage.

Therapeutic drug monitoring for gentamicin

The preceding review questions relating to antibiotic treatment (see Chapters 6, , and ) focus on whether particular antibiotics (or classes of antibiotics) are effective and safe in a general sense (that is, in a population of babies receiving antibiotics) and, if so, which dosage regimen is to be preferred. This review question focuses on ensuring effectiveness and safety in individual babies receiving gentamicin. These are important considerations because the effects of gentamicin are concentration-dependent (rather than time-dependent). Too low a peak concentration will be ineffective against the bacteria that the antibiotic is intended to target (see, for example, Touw 2009). Gentamicin has a post-antibiotic effect, whereby a dosage regimen in which a sufficiently high peak serum gentamicin concentration is followed by a period of low serum gentamicin concentrations will be effective. In contrast, adverse effects of gentamicin (particularly in relation to kidney function and hearing) are more closely related to the total amount of the drug in the circulation (as measured by the area under the concentration:time curve). Thus, adjusting the dosage interval provides a means of ensuring sufficiently low trough serum gentamicin concentrations and, therefore, the safety of the dosage regimen (see Touw 2009). Clinically important variability in gentamicin pharmacokinetics occurs even in babies of the same gestational age and postnatal age, and further variability occurs between babies with and without infection; these sources of variability necessitate individualisation of dosage regimens during gentamicin treatment to ensure effectiveness and safety.

Routine antibiotics after birth

The objectives of this review question are to evaluate the effectiveness of antibiotic prophylaxis administered routinely to all babies after birth, or to well babies in whom maternal or fetal risk factors for early-onset neonatal infection have been identified, to prevent early-onset neonatal infection. Specific issues prioritised by the guideline development group (GDG) for consideration in this question were: potential differences in clinical management, depending on whether intrapartum antibiotics had been administered as prophylaxis to prevent early-onset neonatal infection or for maternal indications; which class of antibiotics to use; timing, route and frequency of antibiotic administration; dosage; and the impact of prematurity on clinical management.

Antibiotics for suspected infection

The objectives of this review question are to identify a safe and effective choice of antibiotics (either individual drugs or classes of drugs to be used alone or in combination) and treatment regimens for babies with suspected early-onset neonatal infection. Specific issues prioritised by the guideline development group (GDG) for consideration in this question were: the need to cover the most likely bacterial pathogens (including group B streptococcus [GBS], the most important Gram-positive organism), E coli (the most important Gram-negative organism) and possibly other organisms such as listeria (L monocytogenes); the use, if possible, of narrow-spectrum antibiotics to reduce the risk of bacterial antibiotic resistance; whether antibiotic blood concentrations need to be monitored; route and frequency of antibiotic administration; dosage; and the impact of prematurity on clinical management.

Guideline summary

These drivers have not always been addressed consistently in the NHS, and this guideline was commissioned to ensure they would be addressed in future.

Introduction

These drivers have not always been addressed consistently in the NHS, and this guideline was commissioned to ensure they would be addressed in future.

Duration of antibiotic treatment

The objectives of this review question are to determine the optimal duration (or course length) of antibiotics administered to babies for the prevention or treatment of early-onset neonatal infection. In prioritising this question for inclusion in the guideline the guideline development group (GDG) sought to distinguish between course lengths required for babies with confirmed early-onset neonatal infection (that is, where a bacterial cause of the infection has been identified), babies with presumed symptomatic infection but with no bacterial cause identified, babies with initial clinical suspicion of infection but no ongoing clinical concerns and all test results normal, and asymptomatic babies receiving antibiotic prophylaxis. Specific issues prioritised by the GDG for consideration in this question included: choice of antibiotics to provide empirical cover for Gram-positive and Gram-negative bacteria; choice of antibiotics to cover particular Gram-positive and Gram-negative bacteria once identified (for example listeria, methicillin-sensitive Staph aureus [MSSA] and methicillin-resistant Staph aureus [MRSA]); timing and route of administration; dosage; and potential differences in course length for systemic and localised (site-specific) infections, including meningitis (which usually requires a longer duration of treatment).

Care setting

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.

Health economics

Health economic analysis in a clinical guideline can support and strengthen recommendations by making explicit comparisons between different treatment strategies in terms of their costs and effectiveness. Where an alternative treatment or testing strategy costs more but has better outcomes than the status quo or next best alternative, economic evaluation can provide guidance as to whether the additional cost represents good value to the NHS compared with all possible other uses for those same resources. The results of cost effectiveness analyses can be used to maximise health gain from the resources available and make decisions about NHS resource use more transparent and defendable.

Risk factors for infection and clinical indicators of possible infection

The objectives of this review question are to evaluate clinical management strategies for prevention and treatment of early-onset neonatal infection based on maternal and fetal risk factors. Several existing NICE guidelines have already identified risk factors for neonatal infection (see below), and so the main emphasis in this question is on determining which risk factors (alone or in combination) are useful for determining the management strategy if babies are identified before or after the birth as being at increased risk. Maternal risk factors are factors associated with the prepregnancy, antenatal, intrapartum and postnatal periods (including antenatal events and consideration of gestational age) and encompassing symptoms and signs in the woman and previous pregnancy history (such as a previous baby having had an early-onset neonatal infection). Fetal risk factors are factors associated with the antenatal or intrapartum periods (whereas symptoms, signs and other factors associated with the baby after birth are considered in a separate review question; see Section 5.2).

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