ACROBAT Newborns

The challenge

Infections in the newborn period are common and can pose a serious threat to a baby’s health. One of the most concerning consequences of infection is sepsis, a massive inflammatory response that can lead to multi-organ failure and death, often at great speed. Globally, an estimated 1.3 to 3.9  million cases of sepsis occur every year in newborns, leading to 400,000 to 700,000 deaths, most on them in sub-Saharan Africa.

In hospitals, a major challenge is to identify babies most at risk of sepsis so that they can be given the most intensive care. An estimated 84% of deaths from sepsis could be prevented with early detection. However, it is difficult to identify at-risk babies based on clinical signs alone, as no reliable predictor of sepsis has been validated yet. Identifying underlying causes of infection is also of limited value since many different types of infection can lead to sepsis. 

It is now becoming clear that, whatever its cause, sepsis progresses through a common physiological pathway. Biomarkers associated with early stages of sepsis progression could therefore help clinicians identify high-risk babies, without needing to know the underlying cause of their condition.

The project

The ACROBAT Newborns project is focusing on a sepsis biomarker known as sTREM-1. This bloodstream marker has been found to be strongly associated with sepsis, and detecting its presence is highly predictive of sepsis development.

Through the Horizon Europe EChiLiBRiST project, the project team developed a sepsis risk-prediction tool based on sTREM for use in children called X-TREM. Using just two drops of blood, it provides results within 10 minutes, stratifying patients into low, medium, or high risk to guide patient management (discharge, monitor, admit, and treat). The test platform uses disposable cartridges with a simple-to-operate handheld reader. 

During the ACROBAT Newborns project, the team is validating the use of this tool among young infants. The new project will test X-TREM on 4,000 sick newborns and 400 healthy controls at first contact with health systems at sites in Ethiopia, Gabon, Mozambique and Uganda. The study will evaluate its clinical performance in the field, comparing results with a wide range of sepsis-detection algorithms and potential sepsis biomarkers (those already incorporated into products or identified in experimental studies). 

The project will track the progress of infants, collect data on vital signs and various physiological parameters, and apply diagnostic tests. This will provide additional valuable information on factors associated with sepsis and poor outcomes, including its association with particular types of infection. 

The project is also testing the usability, feasibility and acceptability of the diagnostic device, to generate evidence to inform final designs and to support successful implementation. It will advance product development to an industrial prototype. The project team will also develop a plan to achieve regulatory approvals in target countries, including CE marking, and develop a business plan to advance the product to market. 

Impact

The ACROBAT Newborns project will provide clinicians in sub-Saharan Africa with a new tool to identify newborn babies at the highest risk of sepsis. It will:

• Advance product development through to the industrial prototype stage.
• Generate evidence on its predictive performance in field settings.
• Gather feedback on users to inform final designs.
• Provide a detailed economic analysis, potential impact studies and implementation scenarios to inform national and international policymaking.

If its potential is confirmed, X-TREM could have multiple benefits, leading to more targeted use of antibiotics and other healthcare resources and, most importantly, reducing the impact of a condition responsible for around half of child mortality in sub-Saharan Africa.