Surv

Surveillance
eillance report 2017 – Neonatal
infection early onset (2012) NICE
guideline CG149

Surveillance report
Published: 9 January 2017
nice.org.uk

© NICE 2017. All rights reserved.

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

Contents
Surveillance decision ......................................................................................................................................................... 3

Reason for the decision ................................................................................................................................................................. 3

Commentary on selected new evidence .................................................................................................................... 7

Investigations before starting antibiotics in the baby and duration of antibiotic treatment – Single C-
reactive protein measurement at 18 hours .......................................................................................................................... 7

Investigations before starting antibiotics in the baby and duration of antibiotic treatment – Effects of
implementing NICE's guideline on neonatal infection in a single UK neonatal unit ............................................. 9

Maternal group B streptococcus status to guide the decision on timing of delivery in women with
preterm premature rupture of membranes .......................................................................................................................... 12

How we made the decision..............................................................................................................................................16

New evidence .................................................................................................................................................................................... 16

Views of topic experts.................................................................................................................................................................... 16

Views of stakeholders .................................................................................................................................................................... 16

NICE Surveillance programme project team ........................................................................................................................ 17

© NICE 2017. All rights reserved. Page 2 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

Surv
Surveillance
eillance decision

We will plan an update of the following sections of the guideline:

Risk factors for infection and clinical indicators of possible infection.

Intrapartum antibiotics.

New area: maternal group B streptococcus status to guide the decision on timing of delivery in
women with preterm prelabour rupture of membranes.

An extension to the scope will be needed to cover antibiotic treatment for late-onset neonatal
infection.

We will amend the guideline to:

Remove references to 'NICE clinical guideline 55', which has now been replaced by NICE's
guideline on intrapartum care for healthy women and babies (NICE guideline CG190).

Cross-refer to NICE's guideline on preterm labour and birth at relevant points.

Modify tables 1 and 2, in section 1.2.1 'Recognising risk factors and clinical indicators', to group
the red flags at the top of the table and to indicate the red flags more clearly (such as using the
word 'Red flag' instead of 'Yes').

Reason for the decision

We found 57 studies through surveillance of this guideline.

New evidence that could affect recommendations was identified. Topic experts, including those
who helped to develop the guideline, advised us about whether the following sections of the
guideline should be updated and any new sections added:

Risk factors for infection and clinical indicators of possible infection

Which maternal and fetal risk factors for early-onset neonatal infection/sepsis should be used
to guide management?

NICE's guideline on neonatal infection (early onset) includes a table of risk factors for early-onset
neonatal infection. The table does not currently list maternal obesity as a risk factor. Evidence
identified at the 4-year surveillance review suggested that, after adjusting for maternal

© NICE 2017. All rights reserved. Page 3 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

comorbidities (diabetes, gestational diabetes, hypertension, and preeclampsia), there was a

significantly higher incidence of sepsis among newborns of obese women than women of a healthy
weight. Topic experts had some concerns about the evidence, for example it was not clear how
much of the reported infection was early onset, almost a third of participants were excluded for
having no BMI data, and the study was from the USA therefore may not be fully generalisable to the
UK. However the experts stated that although the evidence from the 4-year review in isolation
does not warrant a change to recommendations, this issue should be examined further.

Topic experts raised some additional concerns about risk factors. They noted that the wording and
interpretation of some current risk factors and red flags in the guideline (particularly those
concerning maternal infection, intrapartum fever, and parenteral antibiotics) may have led to
increasing, and in some cases unnecessary, use of antibiotics in infants. A related issue was noted to
be the increasing awareness of sepsis 6, which may have led to a rise in maternal intravenous
antibiotics – a knock-on effect being rising use of antibiotics in infants. These issues will need to be
examined and impact on the guideline considered. It was noted that NICE's guideline on sepsis
(whose scope and recommendations include pregnant women) should be considered during
assessment of any impact.

Decision: This review question should be updated.

Intr
Intrapartum
apartum antibiotics

What is the effectiveness of intrapartum antibiotic prophylaxis in the prevention of early-

onset neonatal infection (compared to no treatment)?

A difference was identified between the Royal College of Obstetricians and Gynaecologists Green-
top Guideline 36 ('The prevention of early-onset neonatal group B streptococcal disease') and
NICE's guideline on neonatal infection.

The Green-top Guideline 36 says 'Antibiotic prophylaxis for group B streptococcus is

unnecessary for women with preterm rupture of membranes'. It further notes 'Antibiotic
administration specifically for group B streptococcus colonisation is not necessary prior to
labour and should not be given 'just in case'. If these women are known to be colonised with
group B streptococcus, intrapartum antibiotic prophylaxis should be offered.'

The NICE guideline says 'Consider intrapartum antibiotic prophylaxis using intravenous
benzylpenicillin to prevent early-onset neonatal infection for women in preterm labour if there
is prelabour rupture of membranes of any duration.'

© NICE 2017. All rights reserved. Page 4 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

Topic experts agreed there is a discrepancy and that local practice is split. They noted that there is
not good evidence in this area and it has been interpreted differently by the Royal College and
NICE. Given the current differences between the 2 guidelines, it would be useful to look again at
the evidence.

Decision: This review question should be updated.

Maternal group B streptococcus status to guide the decision on timing of deliv

delivery
ery in
women with preterm prelabour rupture of membr
membranes
anes

New review question – What is the clinical and cost effectiveness of immediate delivery versus
expectant management in women with preterm prelabour rupture of membranes and vaginal
group B streptococcus colonisation?

NICE's guideline on neonatal infection recommends that intrapartum antibiotic prophylaxis should
be considered in women with preterm prelabour rupture of membranes, but no mention is made of
assessing their group B streptococcus colonisation status, or considering immediate or delayed
delivery based on this status. Evidence identified at the 4-year review indicates that in women with
prelabour rupture of membranes between 34 and 37 weeks who have group B streptococcus
vaginal colonisation, immediate delivery appears to reduce risk of early-onset neonatal sepsis.
While in non-colonised women, labour induction could be delayed until 37 weeks. Topic experts
stated that this issue warranted further investigation.

Decision: This review question should be added.

Scope e
extension
xtension

Extension of scope to cover antibiotic treatment for late-onset neonatal infection.

The following placeholder statement was published as part of quality standard 75 Neonatal
infection (December 2014): Quality statement 6 (placeholder) – Antibiotic treatment for late-onset
neonatal infection.

The statement notes that there is a need for evidence-based guidance on the appropriate use of
antibiotics in late-onset neonatal bacterial infection (infection arising more than 72 hours after
birth). Topic experts were unanimous about the need for guidance in this area. This goes beyond the
remit of NICE's guideline on neonatal infection which covers early-onset neonatal infection
(defined as within 72 hours of birth). An extension of the scope is therefore needed to cover
antibiotic treatment for late-onset neonatal infection.

© NICE 2017. All rights reserved. Page 5 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

Decision: The scope should be extended.

Other clinical areas

We also found new evidence that was not thought to have an effect on current recommendations.
This evidence related to information and support, avoiding routine use of antibiotics in the baby,
investigations before starting antibiotics in the baby, duration of antibiotic treatment, and
antibiotics for suspected infection.

We did not find any new evidence related to therapeutic drug monitoring for gentamicin, or care
setting.

Equalities

No equalities issues were identified during the surveillance process.

Ov
Over
erall
all decision

After considering all the new evidence and views of topic experts, we decided that a partial update
and a modified scope is necessary for this guideline.

See how we made the decision for further information.

© NICE 2017. All rights reserved. Page 6 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

Commentary on selected new e

evidence
vidence

With advice from topic experts we selected 3 studies for further commentary.

Investigations before starting antibiotics in the baby and duration of antibiotic

treatment – Single C-reactive protein measurement at 18 hours

We selected the prospective cohort study by Lacaze-Masmonteil et al. (2014) for a full
commentary because the study was highlighted as important by topic expert feedback, and there is
a potential impact on recommendations in NICE's guideline on neonatal infection (early onset)
about when to assess and how to interpret CRP levels.

What the guideline recommends

When starting antibiotic treatment in babies with risk factors for infection or clinical indicators of
possible infection, NICE's guideline on neonatal infection recommends performing a blood culture
before administering the first dose, and measuring the CRP concentration at presentation and
again 18–24 hours later.

It recommends considering stopping the antibiotics at 36 hours if:

the blood culture is negative, and

the initial clinical suspicion of infection was not strong, and

the baby's clinical condition is reassuring with no clinical indicators of possible infection, and

the levels and trends of CRP concentration are reassuring.

Methods

The prospective cohort study by Lacaze-Masmonteil et al. (2014) examined whether a single CRP
measurement at 18 hours of age was able to identify neonates in whom antibiotics started for
possible early-onset sepsis could safely be stopped. Babies were eligible for the study if they had at
least 1 of the following risk factors for early-onset sepsis: (1) less than 37 weeks' gestation with
either spontaneous preterm labour or preterm and prelabour rupture of the membranes; (2) 35 or
more weeks' gestation with positive maternal group B streptococcus screening and inadequate
perpartum antibiotic prophylaxis; (3) any gestational age with prolonged rupture of membranes
(more than 18 hours) or clinical chorioamnionitis. The study included 647 preterm (less than

© NICE 2017. All rights reserved. Page 7 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

35 weeks' gestation) and 555 late preterm (35–36 weeks' gestation) or term newborns. CRP levels
were measured between 15–21 hours of age.

Results

Among the 645 neonates with an 18-hour CRP level less than 10 mg/litre, 1 had proven early-onset
sepsis, 43 had possible early-onset sepsis and 601 (93%) were not infected. Among the 557
neonates with an 18-hour CRP level greater than 10 mg/litre, 15 had proven early-onset sepsis, 64
had possible early-onset sepsis, and 478 (86%) were not infected. All infants (n=189) older than 34
weeks' gestation, asymptomatic within 18 hours of age, and with an 18-hour CRP less than 10 mg/
litre, were not infected (except 1 asymptomatic infant classified as possible sepsis because
antibiotics were continued following bacteraemia in the mother).

Sensitivity and specificity of 18-hour CRP for proven or possible early-onset sepsis were 64% (95%
confidence interval [CI] 56 to 73%) and 56% (95% CI 53 to 59%) respectively. The negative
predictive value was 93% (95% CI 91 to 95%), and the positive predictive value was 14% (95% CI
11 to 17%).

Strengths and limitations

Str
Strengths
engths

All healthcare providers were kept unaware of the CRP results during the study period, which
may have helped to minimise bias.

Limitations

It was not reported if the CRP test was interpreted and logged before the culture result was
known, which has the potential to introduce bias.

Blood cultures were taken for use as the reference standard, but the study did not discuss
culture results as part of any decision to stop antibiotics. The culture result is a key
consideration in NICE's guideline on neonatal infection.

The inclusion criteria for the study were based on maternal and neonatal risk factors for early-
onset sepsis, not all of which align directly with the risk factors noted in the guideline.

'Possible sepsis' was defined as the clinician continuing antibiotics for more than 72 hours
(despite a negative blood culture) in infants born to mothers who had received intrapartum

© NICE 2017. All rights reserved. Page 8 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

antibiotics. No additional clinical or laboratory correlates were obtained, introducing some

uncertainty into this categorisation.

The study was in Canada where pathogens may be different (topic experts suggested a higher
percentage of group B streptococcus in the UK).

Impact on guideline

In the study, all neonates (except 1) who were more than 34 weeks' gestation, asymptomatic at
18 hours of age, and had an 18-hour CRP of less than 10 mg/litre were uninfected. The study
authors therefore concluded that these criteria could be used to stop antibiotics at 24 hours rather
than at 48–72 hours, though they did not go on to validate the criteria. The authors also noted that
elevated 18-hour CRP in isolation should not be used as a reason to prolong antibiotics.

NICE's guideline on neonatal infection recommends measuring CRP 18–24 hours after
presentation, but it is not until 36 hours after commencing antibiotics that the guideline
recommends using levels and trends of CRP, alongside the blood culture result and other factors, to
inform a decision to consider stopping antibiotics.

Topic experts noted that although it is important to consider any evidence that could lead to less
antibiotic use, the sensitivity and specificity of the 18-hour CRP test was low. It may not therefore
be an appropriate measure to use in isolation for diagnostics or to decide antibiotic course length.
The experts further noted that many neonatal units have not been able to implement 36 hour
reports on blood cultures (and have retained 48 hour reports) and would likely find it difficult to
move to a decision rule based on CRP only. The study did not examine interpreting CRP tests in the
context of blood culture results. Further research is needed to examine the role of blood cultures,
and to validate the 18-hour CRP test alongside other criteria for stopping antibiotics. For these
reasons, the study is unlikely to impact on current recommendations.

Investigations before starting antibiotics in the baby and duration of antibiotic

treatment – Effects of implementing NICE's guideline on neonatal infection in a
single UK neonatal unit

We selected the before-and-after study by Mukherjee et al. (2015) for a full commentary because
the study was highlighted as important by topic expert feedback. It is of direct relevance to NICE's
guideline on neonatal infection in reporting potentially negative effects of local implementation of
the guideline.

© NICE 2017. All rights reserved. Page 9 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

What the guideline recommends

When starting antibiotic treatment in babies with risk factors for infection or clinical indicators of
possible infection, NICE's guideline on neonatal infection recommends performing a blood culture
before administering the first dose, and measuring the CRP concentration at presentation and
again 18–24 hours later.

It further recommends considering performing a lumbar puncture in a baby who did not have a
lumbar puncture at presentation who is receiving antibiotics, if it is thought safe to do so and if the
baby:

has a CRP concentration of 10 mg/litre or greater, or

has a positive blood culture, or

does not respond satisfactorily to antibiotic treatment.

It recommends considering stopping the antibiotics at 36 hours if:

the blood culture is negative, and

the initial clinical suspicion of infection was not strong, and

the baby's clinical condition is reassuring with no clinical indicators of possible infection, and

the levels and trends of CRP concentration are reassuring.

Methods

The before-and-after study by Mukherjee et al. (2015) investigated the effect of implementing
NICE's guideline on neonatal infection on the number of investigations, length of stay and duration
of antibiotics in a single UK neonatal unit. The particular focus of the study was the guideline's
recommendation to perform a second CRP measurement 18–24 hours after presentation, and the
subsequent recommendation to consider a lumbar puncture in a baby who did not have one at
presentation guided by (among other criteria) the CRP level.

Infants who had septic screens for early-onset sepsis risk factors were retrospectively evaluated
using hospital records and a neonatal database. Two time periods were compared: a 2-month
period before the NICE guideline was published (n=76 infants), and another 2-month period after
the guideline had been locally implemented (n=66 infants).

© NICE 2017. All rights reserved. Page 10 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

Results

After implementing NICE guidance, the number of second CRP tests performed increased from
45% in period 1 to 97% in period 2. In period 2, repeat CRP values were higher in 58% of babies.
Lumbar punctures performed increased from 14% in period 1 to 23% in period 2. Hospital stays of
72 hours or less among screened babies decreased from 38% in period 1 to 18% in period 2.
However, hospital stays of more than 5 days increased from 21% to 28%. It was stated that
antibiotic use increased in period 2, though numerical data were not reported for this outcome. No
statistical analysis of the changes in value for any outcomes was performed.

Prolonged rupture of membranes (more than 24 hours) was the most common risk factor in both
the groups. There were no positive blood cultures or lumbar punctures.

Strengths and limitations

Str
Strengths
engths

The study is directly relevant in examining the implementation and subsequent impact of
NICE's guideline on neonatal infection.

Limitations

The study was a retrospective examination of records of 142 infants and no statistical analysis
of the data was reported.

The study was performed in a single neonatal unit, and may not reflect implementation in
other settings.

The local protocol used at the neonatal unit before the NICE guidance was introduced was not
reported, therefore interpretation and wider applicability of these findings is unclear.

Inclusion and exclusion criteria were not explicit, particularly regarding sepsis risk factors. The
most common risk factor reported was prolonged rupture of membranes, whereas the risk
factor in NICE's guideline on neonatal infection is prelabour rupture of membranes. Topic
experts noted that including prolonged rupture of membranes as a risk factor will have
included a range of healthy babies in whom tests such as CRP have reduced positive predictive
value.

Topic experts noted that the clinical discretion advocated in the guideline may not have been
applied in this study. For example, the authors appeared to have interpreted recommendation
1.7.1.2 as mandating a lumbar puncture if the second CRP was greater than 10 mg/litre.

© NICE 2017. All rights reserved. Page 11 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

Whereas the recommendation wording uses the verb 'consider' to indicate weak evidence and
when clinicians should employ judgment (see 'Making decisions using NICE guidelines').

Topic experts also noted that the authors appear to have extended the recommendation to
include well, asymptomatic babies. This was not the intent of the guideline which recognises
the very low yield of any lumbar punctures in babies who are well and asymptomatic at
presentation: Recommendation 1.5.1.3 – '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.'

Impact on guideline

The study indicates that implementation of NICE's guideline on neonatal infection in a particular
unit led to increases in investigations, lumbar punctures and durations of treatment and stay.
Although this is a small, single-unit study with no statistical analysis, topic experts noted that the
results may suggest that users of the NICE guideline may be having difficulty in determining which
babies should be investigated and treated for infection.

However, the topic experts further stated that there is a need to reinforce the correct
interpretation and implementation of the guideline (for example the word 'consider' does not
mandate an action) rather than reword the guideline. Therefore no impact on the guideline is
expected.

Maternal group B streptococcus status to guide the decision on timing of

delivery in women with preterm premature rupture of membranes

We selected the secondary analysis of 2 randomised controlled trials (RCT) by Tajik et al. (2014) for
a full commentary because it was highlighted by topic experts, and it examines management
options for women with PPROM that are not currently discussed in NICE's guideline on neonatal
infection.

What the guideline recommends

NICE's guideline on neonatal infection recommends that intrapartum antibiotic prophylaxis should
be considered in women with PPROM, but no mention is made of assessing their group B
streptococcus colonisation status, or considering immediate or delayed delivery based on this
status.

© NICE 2017. All rights reserved. Page 12 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

NICE's guideline on inducing labour recommends that 'If a woman has PPROM after 34 weeks, the
maternity team should discuss the following factors with her before a decision is made about
whether to induce labour: risks to the woman (for example, sepsis, possible need for caesarean
section); risks to the baby (for example, sepsis, problems relating to preterm birth).'

NICE's guideline on preterm labour and birth makes recommendations on identifying infection in
women with PPROM, but does not discuss testing for group B streptococcus colonisation or using
colonisation status to make decisions on timing of delivery.

Methods

The secondary analysis of 2 RCTs by Tajik et al. (2014) investigated whether women with vaginal
group B streptococcus colonisation and PPROM would benefit from immediate delivery versus
expectant management. The 2 RCTs included 723 women across 60 hospitals in the Netherlands
with a singleton or twin pregnancy between 34 and 37 weeks of gestation who were not in labour
24 hours after PPROM. Participants were randomised to immediate delivery (labour induced
within 48 hours, or caesarean delivery if vaginal delivery was contraindicated) or expectant
management (monitoring based on local protocol until onset of spontaneous delivery). In the
expectant management group, labour was induced if the pregnancy reached 37+0 weeks, or could
be induced before this if clinically necessary (such as for infection). Most women were managed as
inpatients but some centres allowed outpatient management. Antepartum and intrapartum
antibiotics were given according to local protocols.

The primary outcome of the original RCTs was early-onset neonatal sepsis. This was defined as a
positive blood culture taken at birth (not Staphylococcus epidermidis) or, within 72 hours, 2 or more
symptoms of infection (apnoea, temperature instability, lethargy, feeding intolerance, respiratory
distress, haemodynamic instability) plus 1 of the following: (i) positive blood culture, (ii) CRP above
20 mmol/litre, or (iii) positive surface cultures of a known virulent pathogen. The primary aim of
this secondary analysis was whether immediate delivery benefited women with PPROM and
vaginal group B streptococcus colonisation based on a logistic regression model. All analyses were
intention-to-treat.

Results

In the original RCTs, immediate delivery did not significantly reduce the risk of early-onset neonatal
sepsis compared with expectant management. In this analysis, when only women with vaginal
group B streptococcus colonisation (14% of participants) were considered, the risk of neonatal
sepsis was significantly lower with immediate delivery than expectant management: odds
ratio=0.10 (95% [CI] 0.01 to 0.84). However in women without colonisation, the risk of neonatal

© NICE 2017. All rights reserved. Page 13 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

sepsis did not differ significantly between the immediate delivery and expectant management
groups: odds ratio=1.16 (95% CI 0.44 to 3.03). When these odds ratios were compared, a
significant difference was observed between the effect of immediate delivery in colonised and
uncolonised women (p=0.04). Namely, that immediate delivery appeared to reduce the risk of
early-onset neonatal sepsis in women with PPROM who also had vaginal group B streptococcus
colonisation.

Strengths and limitations

Str
Strengths
engths

The analysis was based on data from 2 multicentre RCTs.

Limitations

The study authors acknowledged that this was a secondary analysis not pre-specified in the
trial protocols. Therefore, they stated that findings should be validated before applying to
clinical practice.

Antibiotics were given according to local protocols which introduced variability across study
centres. Antibiotic use was also found to differ between groups, but antibiotics were not
factored into the analysis.

Group B streptococcus colonisation status was based only on vaginal swab (no anal swabs
were taken), which may have underestimated the number of carriers. Additionally, for some
patients, vaginal swabs were obtained during admission and not at study entry.

No protocol for uniform specimen handling was used, and the media used for culturing samples
to identify group B streptococcus varied across participating centres.

The original RCTs and this analysis were not powered to detect differences in rare outcomes
such as maternal sepsis.

Implementing the findings of the study would require group B streptococcus screening to be
introduced in a subset of women, but health economic data and impact on health services and
patients were not considered.

© NICE 2017. All rights reserved. Page 14 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

Impact on guideline

The evidence suggests that women with PPROM between 34 and 37 weeks' gestation might
benefit from immediate delivery if they have group B streptococcus vaginal colonisation, while in
non-colonised women labour induction could be delayed until 37 weeks.

NICE's guideline on neonatal infection currently recommends that intrapartum antibiotic

prophylaxis should be considered in women with PPROM, but no mention is made of assessing
their group B streptococcus colonisation status, or considering immediate or delayed delivery
based on this status. Screening is out of scope for this guideline, and topic experts noted that
changing recommendations in this area would amount to starting a screening campaign in a subset
of women with PPROM.

The UK National Screening Committee recommends that screening for group B streptococcus
should not be offered to all pregnant women. However this recommendation is related to informing
a decision about whether to give intrapartum antibiotic prophylaxis, rather than any other
intervention such as immediate or delayed delivery. Additionally, no recommendations are made
about screening within subgroups, such as women with PPROM. As the new evidence relates to
assessing a subgroup (and is therefore not considered population screening), it may therefore be
appropriate to consider making NICE recommendations based on this evidence.

Other guidelines may also be affected by this evidence. NICE's guideline on inducing labour makes
recommendations on the decision whether to induce labour in women with PPROM after 34
weeks, including consideration of sepsis risk in the baby. Additionally, NICE's guideline on preterm
labour and birth makes recommendations on identifying infection in women with PPROM, but does
not discuss testing for group B streptococcus colonisation or using colonisation status to make
decisions on timing of delivery. Consideration of the impact of the evidence for these guidelines
may be appropriate, though limitations of the evidence (particularly that it is a post-hoc analysis
with no consideration of costs) should be taken into account.

© NICE 2017. All rights reserved. Page 15 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

How we made the decision

We check our guidelines regularly to ensure they remain up to date. We based the decision on
surveillance 4 years after the publication of neonatal infection (early onset) (2012) NICE guideline
CG149.

For details of the process and update decisions that are available, see ensuring that published
guidelines are current and accurate in 'Developing NICE guidelines: the manual'.

Previous surveillance update decisions for the guideline are on our website.

New evidence

We found 52 new studies in a search for systematic reviews, randomised controlled trials and
observational studies published between 1 January 2014 and 9 March 2016.

Evidence identified in previous surveillance 2 years after publication of the guideline was also
considered. This included 5 studies identified by search.

From all sources, 57 studies were considered to be relevant to the guideline.

We also checked for relevant ongoing research, which will be evaluated again at the next
surveillance review of the guideline.

See appendix A: summary of new evidence from surveillance and references for all new evidence
considered.

Views of topic experts

We considered the views of topic experts, including those who helped to develop the guideline and
other correspondence we have received since the publication of the guideline. This included a
meeting with experts to discuss potential areas for update.

Views of stakeholders

Stakeholders are consulted only if we decide not to update the guideline following checks at 4 and
8 years after publication. Because this was a 4-year surveillance review, and the decision was to
update, we did not consult on the decision.

© NICE 2017. All rights reserved. Page 16 of 17

Surveillance report 2017 – Neonatal infection early onset (2012) NICE guideline CG149

See ensuring that published guidelines are current and accurate in 'Developing NICE guidelines:
the manual' for more details on our consultation processes.

NICE Surveillance programme project team

Sar
Sarah
ah Willett
Associate Director

Philip Alderson
Consultant Clinical Adviser

Emma McFarlane
Technical Adviser

Patrick Langford
Technical Analyst

The NICE project team would like to thank the topic experts who participated in the surveillance
process.

ISBN: 978-1-4731-2255-0

© NICE 2017. All rights reserved. Page 17 of 17