Ghana Newborn Home Visits Neonatal Mortality Trial (Newhints)
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ClinicalTrials.gov Identifier: NCT00623337 |
Recruitment Status :
Completed
First Posted : February 26, 2008
Last Update Posted : August 24, 2017
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Tracking Information | ||||||||||||||||
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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 |
Neonatal mortality rate [ Time Frame: deaths within 28 days of birth ] | |||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
% mothers carrying out promoted newborn care practices [ Time Frame: within 28 days of birth ] | |||||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | |||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Original Other Pre-specified Outcome Measures | 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. |
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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:
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. |
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Study Type ICMJE | Interventional | |||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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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
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||
Estimated Enrollment ICMJE |
15000 | |||||||||||||||
Original Estimated Enrollment ICMJE |
18000 | |||||||||||||||
Actual Study Completion Date ICMJE | April 2010 | |||||||||||||||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | up to 12 Months (Child) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | 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 |
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Has Data Monitoring Committee | Yes | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
Current Responsible Party | London School of Hygiene and Tropical Medicine | |||||||||||||||
Original Responsible Party | Betty Kirkwood, LSHTM | |||||||||||||||
Current Study Sponsor ICMJE | London School of Hygiene and Tropical Medicine | |||||||||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |