NeoOBS shows high death rates among babies with neonatal sepsis

26 Apr 2022

A large study focusing on newborn babies with clinically diagnosed sepsis has revealed the impact of antibiotic resistance on neonatal sepsis, a major cause of death in newborns.



Today at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), the Global Antibiotic Research and Development Partnership (GARDP) has released a second wave of findings from the Neonatal Sepsis Observational Study (NeoOBS). The study shows that an increasing number of babies die of resistant infections as the current treatments have become ineffective.

Neonatal sepsis is life-threatening infection in newborns caused by bacteria or fungi. The first line of treatment includes a broad-spectrum of antibiotics, often misused.

The NeoOBS study assessed how antibiotics are currently being used to treat newborns suffering from sepsis, and to what extent antibiotic resistance makes these treatments ineffective. The aim of the study was to inform the development of improved antibiotic treatment regimens for neonatal sepsis worldwide.

NeoOBS included over 3,200 newborns with clinically diagnosed sepsis across 19 hospitals in 11 countries, predominantly low- and middle-income countries.



The study found that 11% of newborns with suspected neonatal sepsis died across hospitals and regions during the study period. This proportion increased to 18% in newborns where a pathogen was detected in their blood samples.

The mortality of newborns varied markedly between hospitals, ranging from 1% to 27%. 

Findings showed that the use of antibiotics varied noticeably across sites, with many different antibiotic combinations being used, often without any underlying data.

The World Health Organization (WHO) recommends the standard antibiotics – ampicillin plus gentamicin – for the treatment of neonatal sepsis. However, the NeoOBS study showed that many hospitals are using other combinations due to high levels of resistance to the WHO-recommended antibiotics.  

 Using these findings, we are designing an interventional clinical trial, called NeoSep1. This trial aims to identify better treatment regimens to overcome antibiotic resistance to the current recommended treatments.

The NeoSep1 trial will test the safety and effectiveness of new antibiotic combination treatments, comparing them to the existing antibiotic regimens for neonatal sepsis. It will also investigate the effectiveness of other approved but less commonly used antibiotic treatments and describe local patterns of antibiotic resistance.  

The NeoSep1 trial will begin in Kenya and South Africa later this year and will be expanded in up to eight additional countries in 2023. 

The neonatal sepsis study was carried out from 2018 to 2020, and it was a collaboration between GARDP; St George’s, University of London; Penta – Child Health Research; the MRC CTU at UCL, and the University of Antwerp.

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