The Champion Trial  

The rural Neonatal Mortality Rate (NMR) in Mahabubnagar district, Andhra Pradesh is considerably higher than urban locations - 36.6 and 51.4 per cent respectively - reports a 2004 study done by National Family Health Survey (NFHS).

Reasons cited for this high mortality rates include pre-term birth, sepsis (an infection transmitted from the mother or acquired through an unclean delivery and after birth), birth asphyxia caused due to delay in labour and pneumonia.

Lack of Trained Birth Attendants (TBAs), absence of medical equipment, weak infrastructure, irregular supply of drugs and disposables have made most of the Primary Healthcare Centers (PHCs) dysfunctional. Add to this, poor literacy rates, low awareness levels about proper health and hygiene and belief in traditional medicine have spurted high NMR in rural areas. The situation in Mahabubnagar, one of the backward districts in the state is no different.

A pilot initiative in this district had begun as a part of an European commission grant on promoting Safe Motherhood 3 years ago. The programme was on one hand to reenergize the government healthcare services so their delivery would be more accessible and responsive to the community’s needs. Two, the programme was expected to encourage the community to access more of these institutional services. At the end of the programme tenure its impact on the community did become a point of discovery and discussion with institutions that are keen to impact neonatal deaths. 

And it was in this context that we together with a few institutions working for neonatal health initiated a rigorous clinical trial titled Community Health And Material Provision – Impact on Neonates (CHAMPION) to attain a measurable reduction of NMR in rural Andhra Pradesh. The programme is deployed in Nagarkurnool revenue division of Mahabubnagar district, which has the highest NMR2 in the state.

The idea is to provide professional healthcare services for pregnant women and infants in selected set of villages draw inferences and pit the outcome against another set of (control) villages where healthcare services are either non-existent or are inaccessible. It is believed that by implementing the programme in a compare- and-contrast mode, the need and the design of provision of quality healthcare services and its results will become evident.

Details about the trial

This is a 3 year trial commencing June 2008. The trial has received ethical approval from the LV Prasad Institutional Ethics Board and from an internal ethical review committee at the London School of Hygiene and Tropical Medicine.  

What has made international news was that the Trial protocol was published in BMC Pediatrics, an international medical journal, and was reviewed as "an article of outstanding merit and interest in its field."

CHAMPION, has been designed as a randomised cluster controlled trial involving 464 villages in Mahabubnagar district, Andhra Pradesh. Half of these 464 villages are identified as trial villages – where professional healthcare services will be given to pregnant and new mothers - while the rest half designated as control villages are simply under observation.

Services are offered by monitoring all births in the trial villages for 3 years. If there is a clear evidence of effectiveness at the end of 3 years, the control villages will receive the same package of interventions for a period of next 2 years.

Research conducted by various national and international health programmes on neonatal health reveals that a gamut of interventions on expectant mothers can singularly or in combination reduce mortality. Similarly, precautionary measures coupled with proper medication will guard the newborn from infections and injuries thereby bringing down neonatal deaths.

The trial has two key components: a community health education campaign and a system to provide healthcare services to pregnant mothers and infants. The health education campaign was initiated by holding participatory discussions on health and hygiene, involving representative members of panchayat, villagers, rural and private medical practitioners and midwives.

This pilot is also envisaged to devise new strategies and cover factors such as health service cost-barriers that can be overcome with the creation of community health fund or issues of transporting high-risk pregnant women to well-equipped institutions at the time of delivery, logistical and practical details for data collection, community mobilization through cultural practices such as training and capacity building.

As a first step in the pre trial process, baseline surveys and group discussions were conducted to ascertain potential pregnancies and the health status of pregnant women and newborn. A steering committee including partners such as NICE Foundation (health service implementing partner), Naandi (data collection and collation), Effective Intervention, London School of Hygiene and Tropical Medicine (research guidelines, funding and analysis), the government health department personnel and external health consultants was floated to brainstorm the plan of activities, prepare tools of data collection, for orientation and training of field level functionaries.