Global study highlights deaths from neonatal sepsis and urgent need to improve treatment

09 Jun 2023

The NeoOBS global observational study has shown that a growing number of newborns are dying because the antibiotics used to treat sepsis are becoming ineffective.

The study, which involved more than 3,200 newborns at 19 hospitals in 11 countries, has also provided a wealth of high-quality data aimed at improving the treatment of newborn babies with sepsis, a life-threatening bloodstream infection which affects up to 3 million babies a year globally. 

These findings were published today in PLOS Medicine in a paper co-authored by a global team of over 80 researchers spanning four continents.

Every year, 214,000 newborns, mostly in low- and middle-income countries (LMICs), die of sepsis that has become resistant to antibiotics. Newborn babies are particularly at risk of severe infections because of their underdeveloped immune systems.

The study found that there was a high death rate among infants where bacteria were found in the bloodstream, (almost one in five) and a high burden of antibiotic resistance. However, mortality varied significantly between the 19 hospitals in the study, ranging from 1.6% to 27.3%. Deaths from neonatal sepsis were much more frequent in LMICs, where hospitals often face shortages of nurses, beds and space.

Another worrying finding was the wide variation in treatment. Hospitals in the study used more than 200 different antibiotic combinations, and frequently switched antibiotics due to bacteria becoming resistant to the recommended drugs.

Many physicians were forced to use antibiotics such as carbapenems, which are classified by the World Health Organization as “Watch”, meaning their use should be limited. However, these were often the only antibiotics available to treat infections. Last-line antibiotics were prescribed to 15% of babies with neonatal sepsis enrolled in the study.

Using data from the study, the team developed two scores that could be used in clinical trials and in any neonatal intensive care unit worldwide. The NeoSep Severity Score, based on 10 clinical signs and symptoms, could be used by clinicians to identify newborns at high risk of dying and ensure they get special attention more quickly. The NeoSep Recovery Score uses many of the same clinical signs and symptoms and could help clinicians decide whether to escalate treatment. 

The study also aims to inform global guidelines on treatment for newborns with sepsis, which rely on recent and good quality evidence to adapt to the constantly changing landscape of drug resistance.

Researchers have used the NeoOBS results to design a clinical trial which aims to find better treatments for newborn infections and will look at appropriate formulations and dosages for newborn babies. The neonatal sepsis trial (NeoSep1) opened recently in South Africa and Kenya.

The Global Antibiotic Research and Development Partnership (GARDP) led the NeoObs study in collaboration with the MRC Clinical Trials Unit at UCL; St George’s University of London; Penta – Child Health Research; and the University of Antwerp. The MRC CTU at UCL team led the data analysis.

The MRC CTU at UCL has today released an episode of the Trial Talk podcast focusing on the NeoSep1 trial, which follows an episode exploring the findings of the NeoOBS study.

Access the transcript.

Further information: