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Early switch of intravenous to oral antibiotic therapy in clinically well neonates with a probable bacterial infection is as effective as a full course of intravenous antibiotics therapy
  1. Mohammed Abdalhady,
  2. Catherine M Harrison
  1. Neonatology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  1. Correspondence to Dr Mohammed Abdalhady, Leeds Teaching Hospitals NHS Trust, Leeds LS1 3EX, UK; Mohammed.abdalhady{at}

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Study design

Design: Randomised open-label, non-inferiority trial.

Study question

Setting: Multicentre including 17 teaching hospitals in the Netherlands between February 2018 and May 2021.

Patients: 510 infants were included in the study. Inclusion criteria were greater than 35 weeks’ gestation at birth, with weight of at least 2 kg, who were intended to receive a 7-day course of antibiotics for probable bacterial infection. Infants were recruited at postnatal age between 0 day and 28 days.

Probable bacterial infection was defined as the presence of maternal risk factors or clinical symptoms and elevated inflammatory parameters (C reactive protein ≥10 mg/L or elevated procalcitonin concentrations according to the postnatal age-related nomogram) despite blood culture negativity.

253 neonates were assigned to receive oral amoxicillin–clavulanic acid as the intervention group, and 253 neonates continued intravenous antibiotics as the control group.

Intervention: Neonates were randomly assigned (1:1) to the intervention group (switch to oral antibiotics after 48–72 hours) or the control group (continuation on intravenous antibiotics). Both groups were treated for 7 days in total.

Outcomes: The primary outcome was cumulative bacterial reinfection within 28 days after treatment completion, …

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  • Review of article Keij FM, Kornelisse RF, Hartwig NG, et al. Efficacy and safety of switching from intravenous to oral antibiotics (amoxicillin-clavulanic acid) versus a full course of intravenous antibiotics in neonates with probable bacterial infection (RAIN): a multicentre, randomised, open-label, non-inferiority trial. Lancet Child Adolesc Health 2022;6:799–809.

  • Twitter @cath_harrison10

  • Contributors MA wrote the initial paper.CMH revised and edited the manuscript.

  • Provenance and peer review Not commissioned; internally peer reviewed.