BACKGROUND




The original CHAMPION trial randomized 464 villages in Telangana State, India.
Villages were randomized to an intervention aimed at reducing neonatal mortality or to a control arm offering the usual health services.
The health intervention included a package comprising community health promotion (i.e. health education through village health worker-led participatory discussion groups), outreach (i.e. mobile teams providing antenatal and postnatal care in the home or through fixed day health services), and provision of facility-based care (i.e. subsidized access to non-public health centres).
The primary outcome of neonatal mortality was significantly lower in the intervention arm compared to the control arm (52 neonatal deaths per 1000 live births vs 69 per 1000 live births), a reduction of 24% (Relative Risk 0.76; 95% CI 0.64 to 0.90; p=0.0018). The authors concluded that the CHAMPION intervention was strongly justified in this setting, but the trial needed replication in other areas like Madya Pradesh.




INTRODUCTION




The CHAMPION Trial (Community Health And Medical Provision: Impact on Neonates) is a Randomised control trial.
This trial is implemented with technical assistance from London School of Hygiene and Tropical Medicine (LSHTM), UK and supported by Effective Intervention, UK.
The study is conducted in 204 villages in Satna District; Madhya Pradesh India with less than 2500 population and not within a five kilometer radius of Community Health Center and 15 or more children eligible for the education intervention will be selected for the trial.
In the intervention villages the following activities will be carried out; a) Antenatal, postnatal and neonatal care b) community mobilization through participatory learning and action (PLA) c) coordinating referrals to appropriate government health facilities d) health education campaign through theatre, films and other media.
Outreach services are provided in the intervention villages on two to three days per month according to a timetable predetermined by ASHA and the village leaders; these services are called as ‘Fixed Day Services’ (FDS).
The FDS is co-ordinated and supported by a field monitor. The ASHAs will continuously supported by the Midwives to uptake of health services in the target community and carry out the identification and referral of expectant mothers and newborns that are at risk.
At facility level, NICE Foundation will be strengthening the selected Community Health Centres (CHC) to ensure they meet essential services criteria as is defined by the National Health Mission, Government of India.
All the services in these villages are free of cost to the villagers.
At the control villages strips 2 programme will offer eligible children village-based after-school support provided by a trained Community Educator (CE) focusing on literacy and numeracy skills, six days a week during three successive academic years. There would be a comparative study of health indicators of both the villages in the research period.




Objective




The objective of the CHAMPION2 trial is to assess whether a CHAMPION1 trial is also able to improve neonatal survival, albeit in a different region of India.
The study design will be adapted using lessons learned from the original CHAMPION trial, as well as relevant evidence generated since the conception of the original trial.
The Champion2 trial will also be contextualized to socio cultural patterns and behaviors relating to neonatal and maternal health in Madhya Pradesh, India.