Surveillance decision

Surveillance decision

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

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  • Remove references to 'NICE clinical guideline 55', which has now been replaced by NICE's guideline on intrapartum care for healthy women and babies (NICE guideline CG190).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

Intrapartum 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.'

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 delivery in women with preterm prelabour rupture of membranes

  • 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 extension

  • 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.

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.

Overall 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.


This page was last updated: 09 January 2017