Title: NIHR Global Health Research Unit on the prevention and management of stillbirths and neonatal deaths in Sub-Saharan Africa and South Asia
Funder: Department of Health and Social Care

Abstract: Background/Rationale: One baby dies every 16 seconds, before, during or soon after birth, globally. Over 75% of stillbirths or neonatal deaths occur in sub-Saharan Africa and South Asia, but research has been critically neglected in these settings. Exploiting previous substantial gains (NIHR Stillbirth Group/Lugina Africa Midwives’ Research Network) and extended, synergistic partnerships (Imperial/India, Liverpool/Uganda, Manchester/Pakistan), the new NIHR Unit will be a multi-disciplinary, international centre of research excellence for the prevention and management of stillbirths and neonatal deaths in LMICs. From pre-conception to newborn care, across the highest burden settings, the Unit will be a dynamic force, catalysing step-change acceleration of evidence generation and transfer into health-care practice. Our ultimate goal is to end preventable stillbirths, improve support and reduce stigma for parents, focusing on communities with greatest potential for benefit._x000D_ _x000D_ Aim: To establish a Unit that will generate new scientific knowledge and implement solutions for the prevention and management of stillbirths and neonatal deaths._x000D_ _x000D_ Unit objectives are to:_x000D_ 1.Develop and evaluate sustainable, cost-effective solutions to strengthen maternity and newborn care and reduce stillbirths and neonatal deaths in high-burden settings._x000D_ 2.Determine how best to support parents, families, attending health providers and communities who experience a stillbirth or neonatal death._x000D_ 3.Strengthen research capacity with particular (but not exclusive) emphasis on midwives and nurses._x000D_ 4.Create and embed mechanisms of knowledge-transfer in high-burden settings._x000D_ _x000D_ Methods: We will work in Kenya, Malawi, Tanzania, Uganda, Zambia, Zimbabwe, India and Pakistan; countries with national priorities in perinatal death reduction. A whole systems approach, distinguished by its family-centred focus, strong community and stakeholder partnerships, south-south support and ‘fit-for-purpose’ research designs involving low-cost, sustainable interventions co-developed with front-line workers, women, partners and families. Capacity strengthening activities will target individual and institutional capability at all levels. Underpinned by the MRC Framework for Complex Interventions, and focusing on quality of care provision, activities will span the whole childbirth continuum, building on existing programmes. Development will include early phase evidence syntheses, exploratory studies and methodology; feasibility will include operationalisation to guide planning of subsequent evaluation; evaluations will include full scale trials. Implementation will enable tested interventions to be embedded into care. With our integrated and new Community Engagement and Involvement groups (CEI) (lay members/consumer advocates) in partner countries we will address identified knowledge gaps e.g. adolescent care; antenatal care quality/uptake; testing and implementation of strategies to improve intrapartum outcomes, including respectful care. We will challenge stigma and evaluate bereavement support packages, including women with co-morbidities. New partnerships will extend scope to exploring parent partnerships in the care of sick neonates and implementing optimum immediate newborn care. Development of LMIC-specific core outcome sets for perinatal death will address key measurement uncertainty. Creative multi-modal dissemination strategies will support maximal short and longer-term impacts.

Lay abstract: Background: A baby dies before, during or soon after birth, every 16 seconds globally, with devastating impacts for parents. 75% of stillbirths or neonatal deaths occur in Sub-Saharan Africa and South Asia, but research in these settings has been minimal. The new NIHR Unit will bring together leading maternal and newborn health experts to address this huge and largely preventable problem. Our vision is that the Unit will be a globally recognised centre of research excellence, producing effective solutions to end preventable deaths and better support parents/families whose baby dies in Low- and Middle-Income Countries. Combining resources allows faster progress, capitalising on experience and knowledge to devise, test and put into practice improved strategies for better quality and respectful maternity and neonatal care._x000D_ _x000D_ Research Aim: We will generate new scientific knowledge to inform new health care solutions to end preventable stillbirth and neonatal deaths and provide supportive care. We will:_x000D_ 1.Develop and evaluate sustainable solutions to strengthen maternity and newborn care and reduce the number of stillbirth and neonatal deaths in high-burden settings._x000D_ 2.Evaluate how best to support parents, families and communities who experience a stillbirth or neonatal death and attending health providers._x000D_ 3.Strengthen research capacity, with particular (but not exclusive) emphasis on nurses and midwives._x000D_ 4.Develop effective ways of transferring new knowledge to settings with high stillbirth and neonatal deaths._x000D_ _x000D_ Design and Methods: We will work with partners in Sub-Saharan Africa (Kenya, Malawi, Tanzania, Uganda, Zambia, Zimbabwe) and South Asia (India, Pakistan). Our research, spanning pregnancy, birth and post-birth periods, will be distinguished by its family-centred, strong community and stakeholder partnerships, south-south support and ‘fit-for-purpose’ research designs, involving low-cost, sustainable interventions co-developed with front-line workers and women. Developing local researchers’ skills and institutions capacity to lead further research, will be a priority. Using the Medical Research Council framework for complex interventions (steps to assist researchers to develop and evaluate interventions), we will 1) conduct new exploratory work, including synthesising evidence and exploring views and experiences of women, partners, families and healthcare providers; developing sets of core outcomes for accurate standardised measurement for research in LMICs 2) conduct feasibility studies to determine how best to design trials and explore acceptability of interventions; 3) conduct large scale trials to determine whether the interventions developed improve outcomes for women and babies, are acceptable and cost-effective; 4) implement the tested interventions to embed them into care. Focus will include adolescents care, quality and respectful antenatal and labour care, improving immediate newborn care and resuscitation and parent’s involvement in care of sick babies. We will challenge stigma and address support for parents whose baby dies. We will continue working closely with community engagement and involvement (CEI) groups (lay members and community representatives), in partner countries, developing new groups as needed. CEI is integral to our work and contributes from design to dissemination of research, a CEI member will co-chair the advisory board. Findings will be widely shared using different methods to increase impact.

Research activity codes: 5.8 COMPLEMENTARY;6.3 MEDICAL DEVICES;6.6 PSYCHOLOGICAL AND BEHAVIOURAL;8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH