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NICE Clinical Guideline 139: Antibiotics for early-onset neonatal infection DEVELOPING & IMPLEMENTING THE GUIDELINE: LESSONS LEARNED & OPPORTUNITIES Jim Gray Consultant Microbiologist Birmingham Children’s Hospital Birmingham Women’s Hospital Overview • Background to infections in NICUs • Key points from the NICE Clinical Guideline • Applicability of the principles to other areas of clinical care • Opportunities for further research NICU infections in the media • 20 January 2012 – • 22 November 2011 – • Aspergillus infection has closed a neonatal ward at a Greater Manchester hospital. 22 December 2006 – • E.coli probe at baby death ward: ESBL-producing: Luton 14 February 2008 – • Baby dies as bug strikes hospital. A baby has died and six others are in an isolation ward after an infection struck at the neo-natal unit of a Birmingham hospital. 25 October 2008 – • Superbug hit baby ward at University College Hospital: the so-called "gram-negative" bacterium contributed to the death of one baby… 6 January 2009 – • Two babies die, three other E. coli cases in Swansea 30 August 2010 – • Three babies dead after infection at Belfast hospital (Pseudomonas) Babies infected in neonatal unit. Six babies on a hospital neonatal unit in Norfolk have been affected by an outbreak of PVL-producing S. aureus which is usually seen in the community. 26 July 2006 – Board reveals baby superbug cases: four cases of MRSA were reported at the neonatal unit in Edinburgh. Early antibiotic therapy saves lives! Source: Deresinski S Clin Infect Dis. 2007;45:S177-S183 Neonates & antibiotics: special considerations • Antibiotic-resistant bacteria can spread very readily in the NICU setting – Neonates have little or no colonisation resistance – Intensive care increases the risk of HCAI – At Birmingham Women’s Hospital 2.6% of babies are colonised with an antibiotic-resistant Gram-negative bacterium • Hygiene hypothesis: antibiotic exposure (especially broad-spectrum) in early life may increase risk of asthma and atopic dermatitis • Neonatal drug clearance is generally slower Early-onset neonatal sepsis: the size of the problem • Commonest cause is Group B streptococcus – Incidence 0.5/1000 live births • 10% of newborn babies receive intravenous antibiotics 600,000 deliveries pa 60,000 babies treated with antibiotics 600 babies with earlyonset neonatal sepsis 59,400 babies without infection treated with antibiotics Overuse of antibiotics extends to other age groups 50 consecutive children with blood cultures done in ED at BCH 11 had bacterial infection 10 received empiric antibiotics 39 had no evidence of bacterial infection 1 untreated Acknowledgement: Jeff Aston, Antibiotic Pharmacist, BCH All received empiric antibiotics NICE CG149: Antibiotics for early-onset neonatal infection •Important observation: •Lack of good quality evidence •Principles that we used: •Recommend the right antibiotics •Antibiotics that are effective and safe •Cover the likely pathogens •Minimum risk of selection of antibiotic resistance •Limit overall antibiotic use by: •Limiting the number of patients prescribed antibiotics •Stopping antibiotics when infection has been excluded •Limiting the duration of antibiotic therapy for infections NICE Guidance: limiting the number of patients prescribed antibiotics •Indications for antibiotic therapy: •Any ‘red flag’ for high risk of infection •Systemic antibiotic treatment given to the mother for confirmed or suspected invasive bacterial infection within 24 h of the birth •Seizures in the baby •Signs of shock in the baby •Mechanical ventilation in a term baby •Suspected or confirmed infection in a co-twin •2 or more softer risk factors for/signs of infection •Where indicated antibiotic therapy given within 30-60 minutes NICE Guidance: limiting the duration of antibiotic exposure •Criteria for discontinuing antibiotics •Normal CRP at 18-24 h •Negative blood cultures •Clinical judgement •Duration of therapy •7 days for uncomplicated infections •Longer for meningitis Implementation Starting antibiotics • Reduce number of empiric antibiotic courses by devising & applying: • Clinical assessment tools • Timely & rational use of investigations: laboratory-based or point of care •Appropriate antibiotics commenced promptly where indicated Using the right •Avoid use of unnecessarily broad-spectrum antibiotics antibiotic Stopping antibiotics • Use of investigations, & ensuring that results are turned around in a clinically optimal timescale, to allow early cessation of therapy • Optimum duration of therapy for confirmed bacterial infections