Community health and medical provision: impact on neonates (the CHAMPION trial).

Background: The trial aims to evaluate whether neonatal mortality can be reduced through systemic changes to the provision and promotion of healthcare. Neonatal mortality rates in India are high compared to other low income countries, and there is a wide variation of rates across regions. There is evidence that relatively inexpensive interventions may be able to prevent up to 75% of these deaths. One area with a particularly high rate is Mahabubnagar District in Andhra Pradesh, where neonatal mortality is estimated to be in the region of 4-9%. The area suffers from a vicious cycle of both poor supply of and small demand for health care services. The trial will assess whether a package of interventions to facilitate systemic changes to the provision and promotion of healthcare may be able to substantially reduce neonatal mortality in this area and be cost-effective. If successful, the trial is designed so that it should be possible to substantially scale up the project in regions with similarly high neonatal mortality throughout Andhra Pradesh and elsewhere.

Methods/design: This trial will be a cluster-randomised controlled trial involving 464 villages in Mahabubnagar District. The package of interventions will first be introduced in half of the villages with the others serving as controls. The trial will run for a period of three years. The intervention in the trial has two key elements: a community health promotion campaign and a system to contract out healthcare to non-public institutions. The health promotion campaign will include a health education campaign, participatory discussion groups, training of village health workers and midwives, and improved coordination of antenatal services. The intervention group will also have subsidized access to pregnancy-related healthcare services at non-public lth centres (NPHCs). The primary outcome of the trial will be neonatal mortality. Secondary outcomes will include age at and cause of neonatal death, neonatal morbidity, maternal mortality and morbidity, health service usage, costs and several process and knowledge outcomes.

Discussion: The trial will be run by independent research and service delivery arms and supervised by a trial steering committee. A data monitoring committee will be put in place to monitor the trial and recommend stopping/continuation according to a Peto-Haybittle rule. The primary publication for the trial will follow CONSORT guidelines for cluster randomised controlled trials. Criteria for authorship of all papers, presentations and reports resulting from the study will conform to ICMJE standards.