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临床试验/NCT04663620
NCT04663620已完成不适用

Design, Implementation and Assessment of a Comprehensive Community Neonatal Heath Package Utilising Medical and Social Interventions

University of Oxford1 个研究点 分布在 1 个国家目标入组 24,040 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24,040
试验地点
1
主要终点
1. Number of new locations the Saving Babies' Lives programme is replicated in, as assessed by implementation of the programme in a new location

研究概览

简要总结

The central hypothesis of this study is that a neonatal healthcare programme that has a significant impact on neonatal mortality and which spans the healthcare journey from village to referral hospital can be developed and implemented in a low-resource rural setting.

This study is a five-year cluster-randomised trial, covering a rural and isolated province in North-Eastern Cambodia. The intervention of this study is the Saving Babies' Lives programme, which is a comprehensive, contextual and iterative neonatal healthcare package. The Saving Babies' Lives programme comprises a training programme for primary care facilities, and participatory action research with community health workers (known in Cambodia as village health support group volunteers). The control is no intervention; standard government service continues. Qualitative and quantitative data collection supports improvements in the iterative programme, and evaluation of the study, with the intention of creating a scalable blueprint.

Wellcome Trust grant number 220211.

详细描述

Globally the proportion of childhood deaths that occur in the neonatal period is increasing. Since 1990 there has been a 47% reduction in deaths in children less than five years of age. However, this rate of reduction has not been seen in infants four weeks of age or younger (neonates). The reasons why the fall in neonatal mortality has not mirrored that seen in children mortality, is complex and one that is not well explored in the literature. One proposed explanation is that interventions that have been successfully employed to reduce childhood death do not reach the community and it is in the community where most neonates die. Another pervasive perceived barrier to providing neonatal care, particularly in remote and rural areas, is the misconception that neonatal care is difficult and expensive.

Many health problems are rooted in powerlessness. Health education that involves community involvement: dialogue and problem solving, rather than just message giving, is more empowering. Addressing social needs and empowering communities to make decisions about health care needs allows for the design of programmes that account for local practices and beliefs. Up to two-thirds of neonatal deaths could be prevented if neonates were given proper care during and immediately after birth, because the majority of neonatal deaths occur around the time of delivery. Training primary level health care workers to deal with emergency situations that occur around the time of delivery, has been shown to decrease maternal mortality and neonatal mortality It is reported that 79% of deliveries in Cambodia occur in healthcare facilities. The majority of these will occur at primary care facilities. Babies born in primary care facilities who require further care are transferred to the referral hospital. The majority of referral hospitals in Cambodia do not have the resources or skills to effectively deal with neonatal complications for babies born either in health centres or in their on-site maternity wards.

The central hypothesis of this study is that a neonatal healthcare programme that has a significant impact on neonatal mortality and which spans the healthcare journey from village to referral hospital can be developed and implemented in a low-resource rural setting.

This study is a five-year cluster-randomised trial, covering the whole of Preah Vihear province in North-Eastern Cambodia, which is a rural and isolated province. A cluster is defined as a primary care administrative group, as recognised by the provincial health department, and includes all primary care facilities, primary care workers, community health workers, villagers and villages in that geographical area. The study area is divided into 21 clusters. Clusters were pre-assigned to one of two arms: intervention and control. A pilot sequence has only four clusters, to incorporate a pilot phase into study design.

The intervention of this study is the Saving Babies' Lives programme which is a comprehensive, contextual and adaptive neonatal healthcare package. The Saving Babies' Lives Programme will be developed in partnership with the Kingdom of Cambodia Ministry of Health. The programme will be approved by the Ministry of Health and a memorandum of understanding signed with the provincial health director of Preah Vihear province. The control is no intervention; standard government service continues.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Saving Babies Lives Training Programme
  • Study Participants
  • The Saving Babies Lives Programme will be aimed at government health care staff working in the community (Village Health Support Group Workers, (VHSG)), at Health Center (nurses and midwives) and at the referral hospital (doctors and nurses)
  • Inclusion Criteria
  • Staff members chosen by the Provincial Health Director to attend the programme

排除标准

  • Not applicable
  • Village Health Support Group Workers (VHSG) Baby Health Meetings
  • Study Participants
  • Two Village Health Support Group Workers (VHSG) from villages served by each Health Center cluster
  • Adults (aged 18 years or older)
  • Inclusion Criteria
  • Work as a government health care staff working in the community (Village Health Support Group Workers , (VHSG))
  • Live in a village served by a chosen Health Center
  • Are able to commit to attend meetings regularly
  • Give consent to participate in the meetings
  • Exclusion Criteria
  • Refusal to participate
  • Be from a village where two members have already been chosen

研究组 & 干预措施

Saving Babies Lives Programme

Active Comparator

Comprehensive neonatal healthcare package

干预措施: Saving Babies Lives Programme (Behavioral)

No Saving Babies Lives Programme

Placebo Comparator

Control arm

干预措施: No Saving Babies Lives Programme (Behavioral)

结局指标

主要结局

1. Number of new locations the Saving Babies' Lives programme is replicated in, as assessed by implementation of the programme in a new location

时间窗: 5 years

'New location' is defined as consisting of at least one government-run primary care facility (and it's affiliated primary care workers and community health workers) in Cambodia that has not had the Saving Babies' Lives programme implemented before

次要结局

  • Change in perinatal mortality rate as assessed using a surveillance system in Preah Vihear province(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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