A dissemination meeting showcasing the key findings of two pioneering clinical trials aimed at enhancing the management of Possible Serious Bacterial Infection (PSBI) in infants under 2 months of age was held at the Radisson Blu Water Garden Hotel in Dhaka recently. The event was hosted by the Ministry of Health and Family Welfare in collaboration with Projahnmo Research Foundation (PRF), Bangladesh.

These landmark trials provided evidence for innovative approaches to optimise the place of treatment and duration of inpatient care for newborns, paving the way for better neonatal outcomes and are crucial for resource-limited countries like Bangladesh, where limited hospital beds and challenges in referring young infants hinder neonatal care.

Infections in young infants are a major global health concern and a significant contributor to under-five mortality, particularly in low- and middle-income countries (LMICs). In Bangladesh, neonatal mortality stands at 20 per 1,000 live births, with infections accounting for 20%–40% of these deaths. Approximately 8–10% of infants experience at least one episode of PSBI in their first two months of life.

The World Health Organisation (WHO) currently recommends inpatient care, including injectable antibiotics and supportive treatment to treat neonatal infection. However, many of these infants may not require hospitalisation, which carries additional risks such as hospital-acquired infections, complicating care, and longer hospital stays. Hence, there is a need to conduct multicountry, large-sample clinical trials to improve the management of PSBI in young infants less than 2 months of age. In this context, WHO coordinated two clinical trials concurrently across six countries, including Bangladesh, Ethiopia, India, Nigeria, Pakistan, and Tanzania, with funding from the Bill and Melinda Gates Foundation.

In Bangladesh, PRF and Johns Hopkins University, USA, led these trials in collaboration with WHO and the Ministry of Health and Family Welfare, Government of Bangladesh, in the Sylhet district. These trials evaluated the safety and efficacy of outpatient care versus currently recommended inpatient treatment for infants with low-mortality-risk signs of PSBI.

Key findings reveal that young infants with any low-mortality-risk signs can be safely treated with outpatient care, simplifying care for families while maintaining effectiveness. Young infants with moderate-mortality-risk signs who respond well to a 48-hour course of injectable antibiotics can benefit from switch therapy (early discharge on oral antibiotic therapy at home).

These trials prove that infants with PSBI could be safely and effectively treated with first-generation antibiotics, such as amoxicillin, ampicillin, and gentamicin. These innovative approaches may minimise unnecessary hospitalisations, reduce healthcare costs by optimising health systems and family resources, reduce the risk of hospital-acquired infections, and offer families in resource-limited settings a safe, effective, and accessible alternative to standard inpatient care.

The dissemination meeting highlighted the potential impact of these findings and discussed strategies for scaling up evidence-based practices across Bangladesh and other LMICs. These strategies are expected to significantly enhance neonatal care, save countless lives, and address one of the most urgent global health challenges.