title: 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 protocol.
abstract: 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.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov (identifier NCT00623337).
authors.affiliation: Department of Nutrition and Public Health Intervention Research, London School of Hygiene and Tropical Medicine, London, UK. betty.kirkwood@lshtm.ac.uk
authors.forename: Betty R
authors.initials: BR
authors.lastname: Kirkwood
authors.forename: Alexander
authors.initials: A
authors.lastname: Manu
authors.forename: Charlotte
authors.initials: C
authors.lastname: Tawiah-Agyemang
authors.forename: Guus
authors.initials: G
authors.lastname: ten Asbroek
authors.forename: Thomas
authors.initials: T
authors.lastname: Gyan
authors.forename: Benedict
authors.initials: B
authors.lastname: Weobong
authors.forename: R Eric
authors.initials: RE
authors.lastname: Lewandowski
authors.forename: Seyi
authors.initials: S
authors.lastname: Soremekun
authors.forename: Samuel
authors.initials: S
authors.lastname: Danso
authors.forename: Catherine
authors.initials: C
authors.lastname: Pitt
authors.forename: Kara
authors.initials: K
authors.lastname: Hanson
authors.forename: Seth
authors.initials: S
authors.lastname: Owusu-Agyei
authors.forename: Zelee
authors.initials: Z
authors.lastname: Hill
mesh_terms: D002662:Child Health Services / Q000191:economics; D016000:Cluster Analysis; D003362:Cost-Benefit Analysis; D019033:Delivery of Health Care, Integrated; D003906:Developing Countries; D005240:Feasibility Studies; D005260:Female; D005869:Ghana / Q000453:epidemiology; D017048:Health Care Costs; D006700:Home Childbirth / Q000191:economics; D006792:House Calls / Q000191:economics; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D010348:Patient Care Team; D011181:Postnatal Care / Q000191:economics / Q000458:organization & administration; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000191:economics; D011263:Pregnancy Trimester, Third; D011295:Prenatal Care / Q000191:economics / Q000458:organization & administration; D012107:Research Design; D019035:Rural Health Services / Q000191:economics / Q000458:organization & administration