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

DetailsAdditional comments
Review questionHow does the choice of care setting impact on the clinical management of early-onset neonatal infection?This question refers to choice of care setting for birth and any subsequent investigation, treatment etc covered by other review questions

It was initially agreed that evidence to answer the question would be collated from all the other review questions (that is, no additional search would be conducted), but it became necessary to restrict the searches for effectiveness of antibiotic treatment to studies involving RCTs or systematic reviews of RCTs (to ensure a manageable workload for the NCC-WCH technical team and the GDG) and so a focused search (for example, for observational or qualitative studies) will be conducted for this question
ObjectivesTo evaluate the impact of care setting on the clinical management of early-onset neonatal infection

Considerations to include:
  • the woman’s choice of care setting
  • the feasibility of delivering a safe standard of care in different settings (for example, home births, community midwifery)
The aim is to look at care settings after the group has seen the evidence identified in relation to all the other review questions and has a shared idea of what can happen to women and their babies
LanguageEnglish
Study designSystematic reviews

Randomised controlled trials (RCTs)

Cohort studies

Case–control studies

Pharmacokinetic and pharmacodynamic studies

Questionnaires and other survey designs

Cross-sectional studies

Qualitative studies

Discrete choice experiments
To include all study designs considered in relation to the other review questions, and any new study designs specific to this question (for example, qualitative studies to evaluate parents’ or carers’ views and experiences)

Discrete choice experiments (to elicit ‘patient’ preferences) might inform health economic analysis
StatusPublished papers
PopulationPregnant women with risk factors for early-onset neonatal infection in their babies

Babies being treated for suspected or confirmed early-onset neonatal infection
To include all papers on early-onset infection as the authors define it

Studies will be included only if they are conducted in the European Union, the United States of America, Canada, Australia or New Zealand (pathogens and clinical practice outside these areas are not sufficiently similar to those in the UK to be informative)
InterventionClinical management, including risk assessment, observation, investigation, antibiotic prophylaxis, antibiotic treatment and antibiotic level monitoring, conducted in a specified care setting

Subgroup analysis according to care setting:
  • Primary care (including community midwifery, home birth, GP, health visitor and midwifery-led units)
  • Secondary care (consultant-led obstetric, neonatal and paediatric units)
The care settings listed here are to guide systematic reviewers in settings to look out for in published papers; they are not intended to provide an exhaustive list of all possible settings

Health visitor probably not relevant for the guideline population unless recommendations cover management in the community that continues after transfer from midwives to health visitors

Neonatal intensive care (NICU) and transitional care should be included under secondary care

The GDG may wish to consider competencies (for example, can intravenous antibiotics be administered) required to provide the level of care required

The NICE intrapartum care guideline includes clinical questions on place of care. In particular, it includes a question on risk factors to be included in assessment to determine the most appropriate place of birth for women during pregnancy. The NICE intrapartum care guideline recommendations identify women with risk factors associated with group B streptococcus whereby antibiotics in labour would be recommended as a group with a medical condition indicating increased risk suggesting planned birth at an obstetric unit. The NICE intrapartum care guideline also includes clinical questions on labouring and giving birth in water, and these questions specifically consider the risk of maternal and neonatal infections, meaning that the remit of the neonatal antibiotics GDG will not include consideration of evidence relating to labouring and giving birth in water. The GDG may, however, cross-refer to the intrapartum care guideline to raise awareness of the recommendations it contains, and the GDG may consider registering as a stakeholder group for the intrapartum care guideline and submitting suggestions for the focus of the update, the emphasis to be given to the risk of neonatal infection throughout the intrapartum care guideline, and consideration by the intrapartum care GDG of the recommendations contained in this guideline (for example, through cross-referencing to this guideline)
ComparatorClinical management, including risk assessment, observation, investigation, antibiotic prophylaxis, antibiotic treatment and antibiotic level monitoring, conducted in a different care setting

Comparison with usual/routine care
OutcomesFor clinical effectiveness studies:
  1. Cure rates for neonatal infection
  2. Mortality
  3. Duration of hospital stay
  4. Neonatal adverse events
  5. Long-term outcomes
  6. Resistance among neonatal flora
  7. Change in place of care for woman or baby (antibiotic-or infection-related)
Technical definition of cure rate and appropriate surrogate measures (for example, treatment failure) to be specified

Definitions of cure rate might include:
  • 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
While mortality and long-term outcomes were recognised as being important, the GDG did not formally agree an order of priority. The outcomes listed should be addressed in the same order in similar questions
Other criteria for inclusion/exclusion of studiesExclude non-human studies

Exclude late-onset neonatal infection (onset of infection after 72 hours of age)

Exclude studies that do not report results specifically for early-onset neonatal infection (however the authors define it)

Exclude results relating to babies with suspected or confirmed non-bacterial infections

Exclude results relating to babies with suspected or confirmed bacterial infection resulting from therapeutic interventions such as surgery

Exclude results relating to babies with suspected or confirmed syphilis

Exclude results relating to babies with suspected or confirmed meningitis who are not receiving care in neonatal units (covered by the NICE guideline on bacterial meningitis and meningococcal septicaemia)

Exclude results for women with prelabour rupture of membranes at term (this is covered by the NICE intrapartum care guideline)
This section includes generic exclusions specified in the NICE guidelines manual (for example, non-human studies), exclusions specified in the scope for this guideline (for example, late-onset neonatal infection), and any exclusions specific to this review question
Search strategiesSearches should include all of the potential risk factors and population groups listed aboveGDG to consider evidence identified in relation to all other review questions as well as any identified in searches specific to this question
Review strategiesStudies will be assessed for quality according to the process described in the NICE guidelines manual (January 2009)

A list of excluded studies (including reasons for exclusion) will be provided following weeding

Evidence tables and GRADE evidence profiles will be used to summarise the evidence
EqualitiesEqualities issues with be assessed according to the processes described in the NICE guidelines manual (January 2009) and the NICE equality scheme and action plan (2010–2013)

From: Appendix D, Review protocols

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.
Copyright © 2012, National Collaborating Centre for Women’s and Children’s Health.

No part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.