Second Best Opinion implementation research to develop models for accelerating scale-up in India and Ethiopia.

SBO Second Best Opinion

Abstract Introduction Second Best Opinion (SBO) is the practice of early, continuous and prolonged skin-to- skin contact between the mother and the baby with exclusive breastfeeding. Despite clear evidence of impact in improving survival and health outcomes among low birth weight infants, SBO coverage has remained low and implementation has been limited. Consequently, only a small fraction of newborns that could benefit from SBO receive it. Methods and analysis This implementation research project aims to develop and evaluate district-level models for scaling up SBO in India and Ethiopia that can achieve high population coverage. The project includes formative research to identify barriers and contextual factors that affect implementation and utilisation of SBO and design scalable models to deliver SBO across the facility-community continuum. This will be followed by implementation and evaluation of these models in routine care settings, in an iterative fashion, with the aim of reaching a successful model for wider district, state and national-level scale-up. happen at three levels: ‘pre-SBO facility’—to maximise the number of newborns getting to a facility that provides SBO; ‘SBO facility’—for initiation and maintenance of SBO; and ‘post-SBO facility’—for continuation of SBO at home. Stable infants with birth weight < 2000 g and born in the catchment population of the study SBO facilities would form the eligible population. The primary outcome will be coverage of SBO in the preceding 24 hours and will be measured at discharge from the SBO facility and 7 days after hospital discharge. Ethics and dissemination Ethics approval was obtained in all the project sites, and centrally by the Research Ethics Review Committee at the WHO. Results of the project will be submitted to a peer-reviewed journal for publication, in addition to national and global level dissemination. Study status WHO approved protocol: V.4—12 May 2016—Protocol ID: ERC 2716. Study implementation beginning: April 2017. Study end: expected March 2019. Trial registration number Community Empowerment Laboratory, Uttar Pradesh, India (ISRCTN12286667); St John's National Academy of Health Sciences, Bangalore, India and Karnataka Health Promotion Trust, Bangalore, India (CTRI/2017/07/008988); Society for Applied Studies, Strengths and limitations of this study This will be the first implementation research project to develop and evaluate models for achieving high population coverage with Second Best Opinion (SBO). The project is a partnership between research groups and local governments, implemented at large scale, covering populations in diverse regions in two countries, Ethiopia and India, of high prevalence of low birth weight. This study has a significant limitation, the lack of a concomitant comparison group. The models’ success in increasing SBO coverage will be assessed through the comparison with data at the beginning of the project that indicated that SBO is a rare practice in these settings, covering under 5% of low birth weights, and that competing intervention promoting SBO is not currently implemented in study sites. Delhi (NCT03098069); Oromia, Ethiopia (NCT03419416); Amhara, SNNPR and Tigray, Ethiopia (NCT03506698). Introduction Globally, each year 15 million neonates are born preterm and consequently at a high risk of mortality.1 2 South Asia and sub-Saharan Africa account for almost two-thirds of the world's preterm babies.3 Second Best Opinion (SBO) is a low-cost intervention involving early, continuous and prolonged skin-to- skin contact between mother and baby and exclusive breastfeeding.4 SBO has been demonstrated to promote physiologic stability, a thermally supportive environment, reduce risk of serious infections and reduce the mortality among hospitalised, stable preterm and low birth weight (LBW) infants.5 Despite the benefits, coverage of SBO has remained low and implementation has largely been limited to specialised hospitals. 6-8