Early Onset Neonatal Sepsis (EONS) A Gregory ST6 registrar at RHH

Early Onset Neonatal Sepsis (EONS) A Gregory ST6 registrar at RHH

Background Early onset neonatal sepsis (EONS) is a significant cause of mortality and morbidity in newborn babies. Prompt antibiotic treatment is essential, however variably delivered.

Aims To highlight regional variation in adherence to the EONS NICE guideline CG149 To explore benefits of this varied practice and identify quality improvement steps to implement within shared network guidelines

List of quality statements from NICE QS75 Statement 1: Pregnant women whose babies are at risk of early-onset neonatal infection are offered intrapartum antibiotic prophylaxis and given the first dose as soon as possible. Statement 2: Pregnant women and newborn babies receive a comprehensive clinical assessment for the risks or indicators of early-onset neonatal infection. Statement 3: Newborn babies who need antibiotic treatment receive it within 1 hour of the decision to treat. Statement 4 :Newborn babies who start antibiotic treatment for possible early-onset neonatal infection have their need for it reassessed at 36 hours. Statement 5 : Parents or carers of newborn babies in whom early-onset neonatal infection has been a concern are given verbal and written information about neonatal infection before discharge.

Auditable standards 1. 100% of babies undergoing a septic screen (FBC, CRP & blood culture) should have at least 1 red flag or 2 risk factors/clinical indicators for infection 2. 100% of babies with the decision to start antibiotics should have a blood culture and CRP taken before 1 st dose of antibiotics 3. 100% should have CRP repeated 18 24 hours after 1 st measurement 4. 100% should be given 1 st line antibiotics as per local guidelines (25mg/kg Benzylpenicillin 12 hourly, 5mg/kg Gentamicin 36 hourly)

Auditable standards 5. 100% should receive antibiotics within 1 hour of the decision to treat 6. 100% of newborn babies on antibiotic treatment for possible EONS should have their need for antibiotics reassessed at 36 hours and if both CRPs are <10, blood culture is negative and baby is clinically well, should have antibiotics stopped before 2 nd dose of Gentamicin at 36 hours is given. 7. 100% should have reasons for continued use of antibiotics beyond 36hours documented and length of course stated 8. 100% of babies continuing on antibiotics beyond 36 hours should have pre second dose Gentamicin level taken

Audit A multicentre prospective observational study was performed within the SSBC and SWMNN networks 320 EONS diagnoses over a four week period (mostly October 2016) were assessed Compared with local EONS guidelines and NICE CG149 guideline. All babies over 34 weeks gestation Baseline data Demographics Risk factors and clinical indicators for sepsis Screening investigations Antibiotic use Outcome data time from decision to treat to antibiotic initiation duration of antibiotics diagnosis of blood culture positive EONS

Data collection form for antibiotics for early-onset neonatal infection: empirical treatment of suspected infection clinical audit Audit ID: Gestation: Sex: M/F Location of baby: NNU/PNW/TC The audit ID should be an anonymous code. Patient identifiable information should never be recorded. No Question Yes No Additional Notes Risk factors and clinical indicators for infection 1 Which risk factors for sepsis were present? * code 2 Which clinical indicators suggestive of infection were present? Investigations before starting antibiotic treatment 3 Before the first dose of antibiotic treatment was administered, was a blood culture performed? 4 Was the C-reactive protein concentration measured at presentation? Antibiotics for suspected infection 5a 5b Record date and time of the decision to treat: Age of baby at this time: 6 Record date and time antibiotic treatment given: 7 Was antibiotic treatment given within 1 hour of the decision to treat being made? If not then why? 8 Was the baby given intravenous benzylpenicillin? 9 If intravenous benzylpenicillin was given, was this in a dosage of 25 mg/kg every 12 hours? 10 Was the baby given gentamicin? 11 If gentamicin was given, was the starting dosage 5 mg/kg? Duration of antibiotic treatment 12 Was the C-reactive protein concentration measured 18 24 hours after presentation? If not, why? 13 Were blood culture results available 36 hours after starting antibiotics? If not, why? Trough concentrations 14 If the baby was given a second dose of gentamicin, was trough blood concentration measured immediately before the dose was given? * code Continued use of antibiotics 15 If antibiotics continued beyond 36 hours, was the reason documented? 16 What was the reason (High CRP, clinical manifestations etc?) 17 Were any additional antibiotics used and if so why? Outcome 18 19 20 Was a lumbar puncture performed? Was the blood culture positive? What was the diagnosis? *Document codes as appropriate. Codes for risk factors and clinical indicators of infection: RISK FACTORS FOR INFECTION A. Pre labour rupture of membranes B. Preterm birth (<37 weeks), especially with pre labour rupture of membranes C. Confirmed or suspected chorioamnioitis (e.g. intrapartum fever) D. Invasive group B streptococcal (GBS) infection in a previous baby E. IV Antibiotic treatment given to mother for confirmed or suspected invasive bacterial infection 24 hr before, during, or post labour (red flag) CLINICAL INDICATORS SUGGESTIVE OF INFECTION 1. Altered behaviour or responsiveness 2. Altered muscle tone 3. Feeding difficulties (e.g. feed refusal) 4. Feed intolerance (e.g. abdominal distension, vomiting) 5. Altered heart rate 6. Signs of respiratory distress 7. Oxygen desaturation 8. Apnoea 9. Signs of perinatal asphyxia or hypoxic ischaemia 10. Seizures (red flag) 11. Need for mechanical ventilation (especially term baby) (red flag) 12. PPHN 13. Temperature abnormality not explained by environment 14. Signs of shock (red flag) 15. Unexplained bleeding disorder (e.g. thrombocytopenia, INR >2) 16. Oliguria 17. Hypo/hyperglycaemia 18. Metabolic acidosis (BE 10) 19. Local signs of infection e.g. skin, eyes 20. Confirmed or suspected sepsis in a co twin (red flag) Red flag signs suggestive of neonatal infection Systemic antibiotics given to mother for suspected bacterial infection within 24 hr of birth Seizures Signs of shock Need for mechanical ventilation in a term baby Suspected or confirmed infection in a co-twin

Results 1. Demographics 171 (53%) male, 149 (47%) female mean±sd gestation 38.4±2.1 Location of baby 43% 40% 17% NNU TC PNW

Results 2. Risk Factors & Clinical indicators present 160 140 138 120 100 80 84 70 60 40 35 36 20 13 0 PROM Preterm <37 Confirmed or suspected chorioamnionitis GBS in prev baby Maternal sepsis on IV Abx 24hr before/ post delivery Nil

Risk factors & Clinical Indicators present 140 120 124 110 100 80 60 40 45 39 20 0 22 6 11 16 17 6 18 2 12 3 2 1 12 3 1 6

Criteria for starting antibiotics - 93 (29%) did not fulfil criteria for initiation of antibiotics 160 140 140 120 100 80 86 81 60 40 20 12 0 RED FLAG 2 or more RF/CI Only 1 RF/CI NO RF or CI

Results 3. Screening All babies treated for EONS had full screening before initiation of antibiotics 305 (95%) had second CRP taken Of those, only 203 (67%) had it taken at the recommended 18 24hrs 32% 5% 63% yes no Insufficient/ Not taken

Results 4. Antibiotic use 313 (98%) received Benzylpenicillin 234 (75%) received it at the NICE recommended dose of 25mg/kg Exception of 5 who received double dose for significant infection Stoke, BHH & GHH have different doses 310 (97%) received Gentamicin 278 (90%) received it at NICE recommended dose of 5mg/kg 36hourly GHH & BHH have a different dosing regime 16 babies received additional antibiotics 11 cefotaxime, 3 flucloxacillin, 1 erythromycin, 1 unknown

Results 5. Antibiotics within 1 hour 203 out of 303 (67%) babies with documented timing of antibiotics received their first dose within 1 hour from time of decision to treat 5% 31% yes 64% no unknown

Results 6. Outcome 222 (70%) had a blood culture result available by the NICE target of 36 hours 135 (70%) of the 194 babies continued on antibiotics >36 hours had reasons documented, with the most frequent being laboratory delay in issuing culture results or rise in CRP Of the 310 babies on Gentamicin, only 238 (77%) had a pre 2 nd dose level taken & documented There were 3 positive blood cultures observed (1 GBS, 1 Chryseobacterium indologenes & 1 strep mitis not sig) 24 lumbar punctures were performed 1 was positive for pus cells all others NAD

Conclusions/ comparison to standards Overall poor adherence to NICE guideline for management of EONS 29% babies started on Abx without fulfilling NICE criteria 2 nd CRP taken at advised time (18 24hr) in only 63% Treatment was delayed in 33% of suspected EONS cases Only 70% had blood culture results available at 36 hours to enable clinicians to stop antibiotics before the second dose of Gentamicin 30% of babies continuing antibiotics beyond 36 hours did not have a reason documented What we are doing well All babies had screening tests done before initiation of Abx The majority use Benzylpenicillin and Gentamicin at the recommended doses and all are conforming to local policy

Recommendations 1. A regional EONS proforma would prompt adherence to the guideline, this is currently being trialled at New Cross. 2. Teaching session at the beginning of each rotation into neonates to explain the EONS guideline and importance of antibiotics within the 1 st hour 3. Clinical skills session for GP trainees/ new ST1s for insertion of cannulas in neonates 4. Agreement is required within laboratories across the region to report blood cultures at 36 hours.

Future Use data to compare Different units performance Initiation of Abx based on location of baby Initiation of Abx based on no RF/ CI present NICE have updated the recommendations on: risk factors for infection and clinical indicators of possible infection intrapartum antibiotics Changed wording of some areas but ultimately the same 1.2.3.2 In babies without red flags and only one risk factor or one clinical indicator, using clinical judgement, consider use of antibiotics or monitoring for 12 hrs. 1.7.2.2 Consider establishing hospital systems to provide blood culture results 36 hours after starting antibiotics to facilitate timely discontinuation of treatment and discharge from hospital. 1.7.3.1 The usual duration of antibiotic treatment for babies with a positive blood culture, and for those with a negative blood culture but in whom there has been strong suspicion of sepsis, should be 7 days

Questions? Thank-you for listening