Background: In rural India, most births take place in the home, where high-risk care practices are common. We developed an intervention of behaviour change management, with a focus on prevention of hypothermia, aimed at modifying practices and reducing neonatal mortality. Methods: We did a cluster-randomised controlled efficacy trial in Shivgarh, a rural area in Uttar Pradesh. 39 village administrative units (population 104 123) were allocated to one of three groups: a control group, which received the usual services of governmental and non-governmental organisations in the area; an intervention group, which received a preventive package of interventions for essential newborn care (birth preparedness, clean delivery and cord care, thermal care [including skin-to-skin care], breastfeeding promotion, and danger sign recognition); or another intervention group, which received the package of essential newborn care plus use of a liquid crystal hypothermia indicator (ThermoSpot). In the intervention clusters, community health workers delivered the packages via collective meetings and two antenatal and two postnatal household visitations. Outcome measures included changes in newborn-care practices and neonatal mortality rate compared with the control group. Analysis was by intention to treat. This study is registered as International Standard Randomised Control Trial, number NCT00198653. Findings: Improvements in birth preparedness, hygienic delivery, thermal care (including skin-to-skin care), umbilical cord care, skin care, and breastfeeding were seen in intervention arms. There was little change in care-seeking. Compared with controls, neonatal mortality rate was reduced by 54% in the essential newborn-care intervention (rate ratio 0·46 [95% CI 0·35-0·60], p<0·0001) and by 52% in the essential newborn care plus ThermoSpot arm (0·48 [95% CI 0·35-0·66], p<0·0001). Interpretation: A socioculturally contextualised, community-based intervention, targeted at high-risk newborn-care practices, can lead to substantial behavioural modification and reduction in neonatal mortality. This approach can be applied to behaviour change along the continuum of care, harmonise vertical interventions, and build community capacity for sustained development. Funding: USAID and Save the Children-US through a grant from the Bill & Melinda Gates Foundation.
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