Ghana Newborn Home Visits Neonatal Mortality Trial (Newhints)

Tracking Information
First Submitted Date ICMJE	February 15, 2008
First Posted Date ICMJE	February 26, 2008
Last Update Posted Date	August 24, 2017
Study Start Date ICMJE	January 2009
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 15, 2008)	Neonatal mortality rate [ Time Frame: deaths within 28 days of birth ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00623337 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 15, 2008)	% mothers carrying out promoted newborn care practices [ Time Frame: within 28 days of birth ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Ghana Newborn Home Visits Neonatal Mortality Trial
Official Title ICMJE	Cluster Randomised Trial to Evaluate the Impact of Routine Home Visits to Provide a Package of Essential Newborn Care Interventions in the Third Trimester of Pregnancy and the 1st Week of Life on Neonatal Mortality in Rural Ghana
Brief Summary	Introduction: Just under four million infants die each year before reaching one month of age; neonatal deaths now account for 38% of the 10.8 million deaths among children younger than 5 years of age. Tackling neonatal mortality is essential if the millennium development goal to reduce by 2015 overall child mortality by two-thirds from its levels in 1990 is to be achieved. Postnatal care for mothers and neonates in developing countries, particularly when deliveries occur at home, is either not available or is of poor quality. Trained community workers are considered by many to be pivotal to newborn care in the community, as they can act as catalysts for community actions and also be providers of care.Reductions in neonatal mortality have been slower in Sub-Saharan Africa than in any other region, and no evaluations of the effectiveness and feasibility of home visits in reducing neonatal mortality have been conducted. Trial aim: To link with the Ghana Health Service to develop a feasible and sustainable intervention to improve newborn care practices and careseeking during pregnancy and childbirth, and to identify and refer very low birth weight and/or sick babies, through routine home-visits by community health workers (CHWs), and by so doing reduce neonatal mortality.
Detailed Description	Study area: The NEWHINTS trial will be conducted in 6 contiguous districts with an area of 12,000km in the central Brong Ahafo Region of rural Ghana. The area is predominantly rural and has a total population of approximately 600,000 persons, with more than 100,000 women of reproductive age. The study area is multi-ethnic and education levels are low. It is served by 4 district hospitals, and a small number of additional government health centres and private facilities. More than 15,000 babies are born within the area each year; the neonatal mortality rate is about 30 per 1000 live births. Over 50% of births occur at home and these home deliveries account for a large proportion of all neonatal deaths. A potential cadre of CHWs, who are currently working in the region and whose capacity could be expanded to include home visits, are Community Based Surveillance Volunteers (CBSVs); CBSVs currently assist the DHMTs with the registration of births, disease detection and community mobilization. Intervention: The intervention is being developed by a collaborative group from Kintampo Health Research Centre, the District Health Management Teams (DHMTs) of the 6 districts and the London School of Hygiene and Tropical Medicine. It will comprise of: Training CBSVs to identify pregnant women in the community and to conduct 2 home visits during pregnancy and 3 in the first week of life of the infant on days 1, 3 and 7: to promote birth preparedness and prompt careseeking during pregnancy and childbirth to promote essential perinatal and neonatal care practices to identify and refer very low birth weight or sick babies to give advice on special treatment for low birth weight babies to teach neonatal danger signs and encourage prompt careseeking to promote key child survival interventions for infancy (breastfeeding, bednets, immunisations) CBSVs will provide support through dialogue and problem-solving. Other family members key in decision-making concerning childbirth and newborn care will be invited to take part in the discussions.; Developing a sustainable supervisory and remuneration structure for the CBSVs;; Various intervention support activities inc Sensitisation of health facility staff to intervention messages and approach# Sensitisation of traditional birth attendants (TBAs) Meetings with village leaders to introduce intervention aims and activities Community durbars Study design: Formative research consisting of in-depth interviews, focus-groups and pilot trials of home visits/improved practices will be conducted to improve the feasibility and optimality of the planned intervention and to design training and intervention support materials. A cluster randomised controlled trial design with 98 health zones as units of randomisation will be used to evaluate the impact on neonatal mortality, careseeking during pregnancy and childbirth and newborn care practices. The intervention will be implemented in half of the zones, chosen at random, and evaluated over an 18 month period. Impact data will come from ongoing 4-weekly surveillance of all women of child-bearing age and their infants including verbal post mortems, conducted as part of the ongoing "ObaapaVitA" Vitamin A and maternal mortality trial. A process evaluation will be conducted over 3-monthly intervals to assess the coverage and quality of the services provided and the response to the services.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Neonatal Mortality
Intervention ICMJE	Behavioral: Home visits; Home visits by community based surveillance volunteers (2 during pregnancy & 3 during 1st week of life) to promote facility delivery, careseeking during pregnancy and childbirth and essential newborn care practices and to identify & refer sick babies
Study Arms	Experimental: Newhints Home visits Intervention: Behavioral: Home visits; No Intervention: Control Community based surveillance volunteers will continue with current duties eg urging attendance at immunisation clinics and child health weeks
Publications *	Hill Z, Manu A, Tawiah-Agyemang C, Gyan T, Turner K, Weobong B, Ten Asbroek AH, Kirkwood BR. How did formative research inform the development of a home-based neonatal care intervention in rural Ghana? J Perinatol. 2008 Dec;28 Suppl 2:S38-45. doi: 10.1038/jp.2008.172.; Lohela TJ, Nesbitt RC, Manu A, Vesel L, Okyere E, Kirkwood B, Gabrysch S. Competence of health workers in emergency obstetric care: an assessment using clinical vignettes in Brong Ahafo region, Ghana. BMJ Open. 2016 Jun 13;6(6):e010963. doi: 10.1136/bmjopen-2015-010963.; Manu A, Hill Z, Ten Asbroek AH, Soremekun S, Weobong B, Gyan T, Tawiah-Agyemang C, Danso S, Amenga-Etego S, Owusu-Agyei S, Kirkwood BR. Increasing access to care for sick newborns: evidence from the Ghana Newhints cluster-randomised controlled trial. BMJ Open. 2016 Jun 13;6(6):e008107. doi: 10.1136/bmjopen-2015-008107.; Vesel L, Manu A, Lohela TJ, Gabrysch S, Okyere E, Ten Asbroek AH, Hill Z, Agyemang CT, Owusu-Agyei S, Kirkwood BR. Quality of newborn care: a health facility assessment in rural Ghana using survey, vignette and surveillance data. BMJ Open. 2013 May 9;3(5). pii: e002326. doi: 10.1136/bmjopen-2012-002326.; Kirkwood BR, Manu A, ten Asbroek AH, Soremekun S, Weobong B, Gyan T, Danso S, Amenga-Etego S, Tawiah-Agyemang C, Owusu-Agyei S, Hill Z. Effect of the Newhints home-visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomised controlled trial. Lancet. 2013 Jun 22;381(9884):2184-92. doi: 10.1016/S0140-6736(13)60095-1. Epub 2013 Apr 9.; Kirkwood BR, Manu A, Tawiah-Agyemang C, ten Asbroek G, Gyan T, Weobong B, Lewandowski RE, Soremekun S, Danso S, Pitt C, Hanson K, Owusu-Agyei S, Hill Z. 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. Trials. 2010 May 17;11:58. doi: 10.1186/1745-6215-11-58.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: February 17, 2010)	15000
Original Estimated Enrollment ICMJE; (submitted: February 15, 2008)	18000
Actual Study Completion Date	April 2010
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: All live births in trial area Exclusion Criteria:
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 12 Months (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Ghana
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00623337
Other Study ID Numbers ICMJE	Newhints; WHO: C6-181-512,# 007; SNL: Sub-grant # 251; LSHTM: EPNPVE28 & EPNPVP18
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	London School of Hygiene and Tropical Medicine
Study Sponsor ICMJE	London School of Hygiene and Tropical Medicine
Collaborators ICMJE	Kintampo Health Research Centre, Ghana; Institute of Child Health
Investigators ICMJE	Principal Investigator: Betty R Kirkwood London School of Hygiene & Tropical Medicine (LSHTM) Principal Investigator: Zelee E Hill Institute of Child Health, London Principal Investigator: Alexander Manu Kintampo Health Research Centre (KHRC) Principal Investigator: Charlotte Tawiah KHRC Principal Investigator: Seth Owusu-Agyei KHRC
PRS Account	London School of Hygiene and Tropical Medicine
Verification Date	February 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP