This case study describes a research Trial in Nepal, that evaluates the impact of female community health volunteers (FCHV) in diagnosing and managing neonatal sepsis at home and the community. The research is being carried out by Mother and Infant Research Activities (MIRA), an NGO involved in improving the health of the mothers and newborns in Nepal and developing countries through research, training and advocacy, and a member of the Towards 4+5 RPC. The trial has enrolled 7,000 births in the intervention areas and about 10,000 births in control areas. The trial is powered to detect a reduction of 25% in the neonatal mortality rate. If successful this will have major implications for national and international policy relating to the potential role of community volunteers to provide oral antibiotics, especially in rural areas where access to health facilities is limited. In Nepal, the existing network of 50,000 FCHV means that scaling-up such an intervention is potentially feasible within a short time frame.