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Cord Blood Biomarkers to Enhance a Malawian Early Onset Neonatal Infection Risk Prediction Score

An estimated 2.4 million newborn deaths occurred globally in 2019 with newborn deaths accounting for 47% of all under-five deaths. 1/3 of neonatal deaths are due to infection.   This is at risk of increasing further as newborns have some of the highest rates of anti-microbial resistant infections.  Research from MLW has shown that almost 2/3 of neonatal bloodstream infections are resistant to first-line antimicrobialsInfections in babies progress rapidly, yet symptoms and signs are difficult to distinguish from other life-threatening conditions such as complications of prematurity or asphyxia leading to widespread indiscriminate antibiotic use.

Neonatal sepsis risk calculators and biomarker-guided duration of antibiotic therapy are interventions shown to improve the use of antibiotics in babies in high-income countries.  The BAMBI one study aims to derive a risk prediction model to inform prophylactic anti-microbial therapy or enhanced observation of newborns with risk factors for sepsis.  We aim to produce a simple bedside tool that can be used by nurses and doctors caring for newborns in Malawi.  In addition to this, we are investigating if host biomarkers in maternal, neonatal, and cord blood can improve the performance of the predictive model.  We are specifically utilizing the iTPA funding to investigate a much wider spectrum of biomarkers as little is known about the ability of cord blood biomarkers to predict early-onset neonatal infection.

The BAMBI one study recruited 1411 mothers into the study across two sites – Queen Elizabeth Central Hospital and Mlambe Mission Hospital from May 2019 to December 2021.  Ninety-day follow-up of participants is now complete and laboratory work on the study will finish over the next month.  Analysis of study data is in progress.

We will utilise the study results to approach commercial diagnostics partners developing point of care diagnostics.  We will also use the data to inform the development of interventional trials.