NEWHINTS cluster randomised trial to evaluate the impact on neonatal mortality in rural Ghana of routine home visits to provide a package of essential newborn care interventions in the third trimester of pregnancy and the first week of life: Trial protoco
Department of Nutrition and Public Health Intervention Research, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom; Kintampo Health Research Centre, Ghana Health Service, PO Box 200, Kintampo, Brong Ahafo Region, Ghana; Department of Counseling and Clinical Psychology, Columbia University, New York, United States; Department of Global Health and Development, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom; Institute of Child Health, University College London, 30 Guilford Street, London WC1N 1EH, United Kingdom
Background: Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths among children younger than 5 years of age taking place each year; 99% of these occur in low- and middle-income countries where a large proportion of births take place at home, and where postnatal care for mothers and neonates is either not available or is of poor quality. WHO and UNICEF have issued a joint statement calling for governments to implement "Home visits for the newborn child: a strategy to improve survival", following several studies in South Asia which achieved substantial reductions in neonatal mortality through community-based approaches. However, their feasibility and effectiveness have not yet been evaluated in Africa. The Newhints study aims to do this in Ghana and to develop a feasible and sustainable community-based approach to improve newborn care practices, and by so doing improve neonatal survival.Methods: Newhints is an integrated intervention package based on extensive formative research, and developed in close collaboration with seven District Health Management Teams (DHMTs) in Brong Ahafo Region. The core component is training the existing community based surveillance volunteers (CBSVs) to identify pregnant women and to conduct two home visits during pregnancy and three in the first week of life to address essential care practices, and to assess and refer very low birth weight and sick babies. CBSVs are supported by a set of materials, regular supervisory visits, incentives, sensitisation activities with TBAs, health facility staff and communities, and providing training for essential newborn care in health facilities.Newhints is being evaluated through a cluster randomised controlled trial, and intention to treat analyses. The clusters are 98 supervisory zones; 49 have been randomised for implementation of the Newhints intervention, with the other 49 acting as controls. Data on neonatal mortality and care practices will be collected from approximately 15,000 babies through surveillance of women of child-bearing age in the 7 districts. Detailed process, cost and cost-effectiveness evaluations are also being carried out. © 2010 Kirkwood et al; licensee BioMed Central Ltd.
article; clinical trial; community care; controlled clinical trial; controlled study; cost effectiveness analysis; Ghana; health auxiliary; health care quality; home care; human; newborn care; newborn mortality; postnatal care; pregnant woman; randomized controlled trial; rural population; third trimester pregnancy; very low birth weight; child health care; cluster analysis; cost benefit analysis; developing country; economics; feasibility study; female; Ghana; health care cost; home delivery; infant mortality; integrated health care system; methodology; newborn; organization and management; patient care; pregnancy; pregnancy outcome; prenatal care; professional practice; rural health care; third trimester pregnancy; Child Health Services; Cluster Analysis; Cost-Benefit Analysis; Delivery of Health Care, Integrated; Developing Countries; Feasibility Studies; Female; Ghana; Health Care Costs; Home Childbirth; House Calls; Humans; Infant Mortality; Infant, Newborn; Patient Care Team; Postnatal Care; Pregnancy; Pregnancy Outcome; Pregnancy Trimester, Third; Prenatal Care; Research Design; Rural Health Services