Review questionWhat information and support should be provided for parents and carers?

DetailsAdditional comments
Review questionWhat information and support should be provided for parents and carers?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 identify the information and support that should be provided for pregnant women with risk factors for early-onset neonatal infection and for parents and carers of babies at risk of early-onset neonatal infection, and those with suspected or confirmed early-onset neonatal infectionRecommendations arising from this question are likely to include explanations of the rationale for each step in the care pathway and the practical implications or consequences

Such recommendations may include explanations of, for example, which women should be offered intrapartum prophylaxis to prevent early-onset neonatal infection in their babies

The GDG may also consider evidence from studies reporting the views or experiences of women who were offered intrapartum antibiotics or whose babies were offered antibiotic prophylaxis or treatment

Choice of setting for antibiotics may also be relevant (but the GDG will need to consider the potential overlap with the review question relating to care setting)
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
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)
StatusPublished papers
PopulationExpectant parents, and parents and carers of babies who may or may not be at risk of early-onset neonatal infection

Parents and carers of babies with suspected or confirmed early-onset neonatal infection
To include all papers on early-onset infection as the authors define it

Includes expectant parents, pregnant women

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)
InterventionProvision of information or support
ComparatorNo information or support

Comparison between different models of information or support
OutcomesParent satisfaction

Parent involvement in decision-making

Parental anxiety

Parental empowerment

Impact on the baby’s family, including subsequent pregnancies

Health-related quality of life of the baby
Recommendations may need to be based on GDG consensus following consideration of evidence identified for all other review questions (and associated recommendations)
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.

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