This study is a cluster-randomized trial being conducted in the state of Haryana in North India. Eighteen geographical areas served by Primary Health Centres (PHCs) have been randomized to intervention or comparison areas. In the intervention areas, all physicians, health workers and ICDS workers are being trained in the IMNCI. Each of these clusters has an approximate population of 30,000.

The IMNCI intervention includes three main components:

1. improvement in the case management skills of health staff
2. improvement in the overall health system to support its performance, and

3. improvement in family and community health care practices which include:

   • prevention and management of hypothermia
   • early initiation of breastfeeding and exclusive breastfeeding
   • community-based care of low birth weight infants
   • improved care-seeking for neonatal infections

The primary outcome measures of the study are neonatal and infant mortality. The study will also collect information on cause-specific neonatal mortality, ascertained using a standardized previously validated verbal autopsy instrument administered by trained, skilled health workers. All the other outcomes (including initiation of breastfeeding within 1 hour of birth; Exclusive breastfeeding at 4 weeks of age; Proportion of neonates identified to be sick by caregivers who sought care) are secondary outcomes.

The effectiveness of this comprehensive intervention will be measured by comparing the primary and secondary outcome measures in the intervention and comparison clusters, controlling for any baseline differences such as the predefined outcomes and/or socioeconomic status and demography.

The project will serve as a guide to the Government of India of how to best implement the IMNCI strategy and measure its impact.