Introduction Millennium Development Goal-4 for child survival cannot be met without substantial reductions in neonatal mortality (Lawn JE et al. Lancet 2005; 365: ). Every year an estimated 4 million infants die in the first 28 days of life. India accounts for 27% of global neonatal deaths, and 30% of neonatal mortality in India occurs in the state of Uttar Pradesh (UP). The majority of births and neonatal deaths take place at home, away from the reach of skilled providers. Thus, innovative community-based approaches are urgently needed to bring substantial improvement in newborn survival in India. Objectives 1) To develop and evaluate a community-based, community-driven program to deliver the Family Package of interventions (Darmstadt GL, et al. Lancet 2005; 365: ). 2) To determine cost and impact on domiciliary care practices, care- seeking and neonatal mortality in a low-resource, high-mortality setting in rural Uttar Pradesh, India, with a poorly functioning health system. Study Design Cluster-randomized controlled trial in a rural development block (Shivgarh) with 104,000 population; Gram Sabha (cluster of contiguous villages) as the unit of randomization. 39 Gram Sabhas were randomly allocated to one of three study arms: I : Comparison (usual care) II: CM + BCC III: CM + BCC + TS CM = Community Mobilization BCC = Behavior Change Communication TS = ThermoSpot (hypothermia indicator) Study Site: Shivgarh Findings: Reduced mortality Community mobilization and behavior change communication promotes adoption of evidence- based essential newborn care practices and reduces neonatal mortality in Uttar Pradesh, India Darmstadt GL, 1,2 Kumar V, 1,3 Singh P, 3 Singh V, 3 Yadav R, 3 Mohanty S, 3 Bharti N, 3 Gupta S, 3 Mishra RP, 3 Baqui AH, 1 Gupta A, 3 Awasthi S, 3,4 Singh JV, 3 Ahuja RC, 3 Winch PJ, 1 Santosham M 1 1 Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA 2 Save the Children-US, Washington, DC, USA 3 KGMC Institute of Clinical Epidemiology, 4 Department of Pediatrics and 5 Department of Social and Preventive Medicine, King George Medical University, Lucknow, India Conclusion Community mobilization and behavior change communications which avoid conflict with deep-rooted social and cultural values and roles appear to act together to stimulate the adoption of evidence-based newborn care practices, leading to reduced neonatal mortality. Policy Implications In high mortality settings with poorly functioning health systems, initial emphasis on promotion of evidence-based family and community essential newborn care can rapidly improve care practices and substantially lower neonatal mortality, but community demand requires simultaneous attention to clinical care for maternal and newborn complications. Figure 2. View of Shivgarh with allocated Gram Sabhas (a) (b) (c) Figure 1. Neonatal deaths in the state of UP, India, in comparison to other countries Intervention The intervention strategy and BCC package was developed based on formative research and trials of improved practices (TIPS). The approach adopted was: Community mobilization Culturally appropriate BCC Community-based workers (Saksham Sahayak) to deliver BCC messages to pregnant women, their family members and key community stake-holders through home visitations Develop and progressively transfer intervention responsibilities to community volunteers (Saksham Karta) Birth preparedness Clean delivery Immediate breastfeeding Skin-to-skin care (STSC) Thermal care Hygienic cord care and skin care Panel 1. BCC Package Table 1. Study site characteristics The Saksham Sahayak developed a cadre of volunteers (Saksham Karta) who complemented their role. The latter consisted of mothers who benefited from the intervention and influential members of the community who have a stake in newborn care and have volunteered to disseminate and support modification and adoption of evidence-based behaviors by family members. Figure 3. Overview of Intervention visits and data collection Findings: Changes in practices Figure 4. Increased acceptance of skin-to-skin care Figure 5. Increased initiation of breastfeeding on day 0 Figure 6. Deceased bathing on day 0 Figure 7. Survival curves Table 2. Impact on stillbirths, perinatal and neonatal mortality ( 1,2 = per 1000 live births) Acknowledgements Community of Shivgarh