Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH): protocol for a randomised controlled trial.

INTRODUCTION: Procalcitonin (PCT) is a biomarker more specific for bacterial infection and responds quicker than other commonly used biomarkers such as C reactive protein, but is not routinely used in the National Health Service (NHS). Studies mainly in adults show that using PCT to guide clinicians may reduce antibiotic use, reduce hospital stay, with no associated adverse effects such as increased rates of hospital re-admission, incomplete treatment of infections, relapse or death. A review conducted for National Institute for Health and Care Excellence recommends further research on PCT testing to guide antibiotic use in children. METHODS AND ANALYSIS: Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection is a multi-centre, prospective, two-arm, individually Randomised Controlled Trial (RCT) with a 28-day follow-up and internal pilot. The intervention is a PCT-guided algorithm used in conjunction with best practice. The control arm is best practice alone. We plan to recruit 1942 children, aged between 72 hours and up to 18 years old, who are admitted to the hospital and being treated with intravenous antibiotics for suspected or confirmed bacterial infection. Coprimary outcomes are duration of antibiotic use and a composite safety measure. Secondary outcomes include time to switch from broad to narrow spectrum antibiotics, time to discharge, adverse drug reactions, health utility and cost-effectiveness. We will also perform a qualitative process evaluation. Recruitment commenced in June 2018 and paused briefly between March and May 2020 due to the COVID-19 pandemic. ETHICS AND DISSEMINATION: The trial protocol was approved by the HRA and NHS REC (North West Liverpool East REC reference 18/NW/0100). We will publish the results in international peer-reviewed journals and present at scientific meetings. TRIAL REGISTRATION NUMBER: ISRCTN11369832.

Point of care estimation of haemoglobin in neonates.

OBJECTIVE: To evaluate whether measurement of haemoglobin concentration in neonates using point of care testing agrees with laboratory measurement. DESIGN: 127 paired blood samples taken from babies on a neonatal intensive care unit for full blood count and blood gas analysis by point of care testing were reviewed according to current practice. A comparison was made between the laboratory and blood gas analyser haemoglobin measurements to assess limits of agreement and look for any systematic difference. SETTING: Neonatal Unit, Jessop Wing, Royal Hallamshire Hospital, Sheffield, UK PATIENTS: Babies staying on the neonatal unit, who currently have contemporaneous blood samples taken for full blood count and blood gas analysis by point of care testing. INTERVENTION: Results from blood samples were reviewed. MAIN OUTCOME MEASURE: Comparison between laboratory and point of care testing haemoglobin concentrations. RESULTS: The mean laboratory haemoglobin concentration was 155 g/l (range 30-226 g/l); the mean point of care testing haemoglobin concentration was 157 g/l (range 30-228 g/l). The mean (SD) difference between paired samples was 2 (11) g/l; 95% CI -4.0 to 0.1 g/l; and limits of agreement -23 to 19 g/l. CONCLUSIONS: The blood gas analyser on the neonatal unit at Royal Hallamshire Hospital, Sheffield, gives a useful estimation of haemoglobin concentration compared with laboratory measurement, with smaller sample volume. Although this does not replace a full blood count, it is a useful adjunct to neonatal care monitoring.