Discharging Low Risk Neonates with Suspected Early-Onset Sepsis on Oral Antibiotics: An 18 Month Experience

Speaker: Hansini Mandal, United Kingdom

Introduction:

Historically, suspected early-onset neonatal sepsis has been managed with a full 5-day course of IV antibiotics, leading to hospital stays of 5–6 days. However, the RAIN study demonstrated that in asymptomatic neonates, oral antibiotics are non-inferior to IV therapy. Despite this, UK guidelines continue to recommend IV benzylpenicillin and gentamicin.

Study Aims:

  • Develop a guideline to identify low-risk neonates suitable for early discharge on oral antibiotics.
  • Apply conservative criteria compared to the RAIN study to maintain safety within the context of UK practice.
  • Assess the clinical impact, safety, and feasibility of the guideline in real-world settings.

Methods:

  1. Design: Prospective observational audit over 18 months (January 2023 – June 2024).
  2. Setting: A single neonatal unit in the UK.
  3. Inclusion criteria:
    1. Neonates <7 days of age with CRP testing.
    2. CRP between 10–50 mg/L.
    3. Blood culture-negative.
    4. Asymptomatic or mild clinical presentation.
  4. Initial approach:
    1. All neonates with suspected sepsis (via Kaiser Permanente sepsis calculator) received IV antibiotics.
    2. At 36 hours, CRP was measured:
      1. CRP <10 mg/L: Discharged without antibiotics.
      2. CRP ≥10 mg/L: Previously received full IV course.
    3. Revised guideline (from Jan 2023):
      1. CRP 10–25 mg/L: Eligible for direct discharge on oral co-amoxiclav.
      2. CRP 25–50 mg/L: Required lumbar puncture. If CSF WBC <20, eligible for oral discharge.
    4. Follow-up:
      1. Daily telephone follow-up by sepsis specialist nurses to monitor compliance and wellbeing.
      2. Review of readmission records and electronic health records to identify outcomes.

Results:

  1. 12,000 live births during study period.
  2. 1,603 neonates had CRP measured within 7 days of life.
  3. 513 neonates (32%) had CRP >10 mg/L.
  4. 388 (75%) had CRP between 10–50 mg/L and were guideline-eligible for oral antibiotics.
  5. 127 neonates (33% of eligible) were discharged on oral co-amoxiclav.
  6. 5 readmissions:
    1. 2 feeding difficulties
    2. 2 viral illnesses
    3. 1 balanitis
    4. Only 1 required admission (24-hour stay, no further antibiotics).
  7. No readmissions were due to undertreated bacterial infection.
  8. All discharged infants were blood culture-negative.

Clinical Implications:

  • A quarter of treated neonates avoided prolonged IV therapy and were discharged earlier.
  • Admission duration reduced from 5–6 days to approximately 2–3 days.
  • No safety concerns or sepsis-related complications observed.
  • Guideline found to be user-friendly by clinicians.

Future Directions:

  • Expanding eligibility by increasing CRP threshold to 100 mg/L could raise potential discharge candidates from 75% to over 90%.
  • Further evaluation needed on long-term safety and compliance metrics.
  • Potential role in shaping national guideline updates and promoting antibiotic stewardship.

ESPID 2025, 26-30 May, Bucharest