跳至主要内容
临床试验/NCT00623337
NCT00623337已完成3 期

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

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2009年1月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
15,000
试验地点
1
主要终点
Neonatal mortality rate

研究概览

简要总结

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.

详细描述

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:

  1. 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.
  1. Developing a sustainable supervisory and remuneration structure for the CBSVs;
  2. 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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Day 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All live births in trial area

排除标准

  • 未提供

研究组 & 干预措施

Newhints

Experimental

Home visits

干预措施: Home visits (Behavioral)

Control

No Intervention

Community based surveillance volunteers will continue with current duties eg urging attendance at immunisation clinics and child health weeks

结局指标

主要结局

Neonatal mortality rate

时间窗: deaths within 28 days of birth

次要结局

  • % mothers carrying out promoted newborn care practices(within 28 days of birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Ghana Newborn Home Visits Neonatal Mortality Trial | 临床试验