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拯救婴儿生命(SBL)- 一个降低柬埔寨农村地区新生儿死亡率的项目:一项基于阶梯式楔形的群组随机对照试验的研究方案。

Saving babies' lives (SBL) - a programme to reduce neonatal mortality in rural Cambodia: study protocol for a stepped-wedge cluster-randomised trial.

机构信息

Saving Babies' Lives Programme, Angkor Hospital for Children, Tep Vong (Achamean) Road & Oum Chhay Street, Svay Dangkum, Siem Reap, Cambodia.

Cambodia Oxford Medical Research Unit, Angkor Hospital for Children, Tep Vong (Achamean) Road & Oum Chhay Street, Svay Dangkum, Siem Reap, Cambodia.

出版信息

BMC Pediatr. 2021 Sep 7;21(1):390. doi: 10.1186/s12887-021-02833-7.

DOI:10.1186/s12887-021-02833-7
PMID:34493225
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8421466/
Abstract

BACKGROUND

Neonatal mortality remains unacceptably high. Many studies successful at reducing neonatal mortality have failed to realise similar gains at scale. Effective implementation and scale-up of interventions designed to tackle neonatal mortality is a global health priority. Multifaceted programmes targeting the continuum of neonatal care, with sustainability and scalability built into the design, can provide practical insights to solve this challenge. Cambodia has amongst the highest neonatal mortality rates in South-East Asia, with rural areas particularly affected. The primary objective of this study is the design, implementation, and assessment of the Saving Babies' Lives programme, a package of interventions designed to reduce neonatal mortality in rural Cambodia.

METHODS

This study is a five-year stepped-wedge cluster-randomised trial conducted in a rural Cambodian province with an estimated annual delivery rate of 6615. The study is designed to implement and evaluate the Saving Babies' Lives programme, which is the intervention. The Saving Babies' Lives programme is an iterative package of neonatal interventions spanning the continuum of care and integrating into the existing health system. The Saving Babies' Lives programme comprises two major components: participatory learning and action with community health workers, and capacity building of primary care facilities involving facility-based mentorship. Standard government service continues in control arms. Data collection covering the whole study area includes surveillance of all pregnancies, verbal and social autopsies, and quality of care surveys. Mixed methods data collection supports iteration of the complex intervention, and facilitates impact, outcome, process and economic evaluation.

DISCUSSION

Our study uses a robust study design to evaluate and develop a holistic, innovative, contextually relevant and sustainable programme that can be scaled-up to reduce neonatal mortality.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT04663620 . Registered on 11th December 2020, retrospectively registered.

摘要

背景

新生儿死亡率仍然高得令人无法接受。许多成功降低新生儿死亡率的研究未能在规模上取得类似的成果。有效实施和扩大旨在解决新生儿死亡率问题的干预措施是全球卫生的重点。针对新生儿护理连续体的多方面方案,在设计中纳入可持续性和可扩展性,可以为解决这一挑战提供实际的见解。柬埔寨的新生儿死亡率在东南亚地区处于较高水平,农村地区尤其受到影响。本研究的主要目标是设计、实施和评估 Saving Babies' Lives 方案,这是一套旨在降低柬埔寨农村地区新生儿死亡率的干预措施。

方法

这是一项在柬埔寨农村省份进行的为期五年的递进式楔形集群随机试验,估计每年的分娩率为 6615 例。本研究旨在实施和评估 Saving Babies' Lives 方案,该方案是干预措施。Saving Babies' Lives 方案是一个迭代的新生儿干预包,涵盖了护理连续体,并整合到现有的卫生系统中。Saving Babies' Lives 方案包括两个主要组成部分:社区卫生工作者的参与式学习和行动,以及初级保健设施的能力建设,包括基于设施的指导。在对照组中,标准政府服务继续进行。涵盖整个研究区域的数据收集包括对所有妊娠的监测、口头和社会尸检以及护理质量调查。混合方法数据收集支持复杂干预措施的迭代,并促进影响、结果、过程和经济评估。

讨论

我们的研究使用了一种稳健的研究设计来评估和开发一种全面、创新、具有背景相关性和可持续性的方案,可以扩大规模以降低新生儿死亡率。

试验注册

ClinicalTrials.gov:NCT04663620。于 2020 年 12 月 11 日注册,为回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957e/8422733/f4b0aec4a3a0/12887_2021_2833_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957e/8422733/4847b6aa23e5/12887_2021_2833_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957e/8422733/2e39d5a449bf/12887_2021_2833_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957e/8422733/f4b0aec4a3a0/12887_2021_2833_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957e/8422733/4847b6aa23e5/12887_2021_2833_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957e/8422733/2e39d5a449bf/12887_2021_2833_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/957e/8422733/f4b0aec4a3a0/12887_2021_2833_Fig3_HTML.jpg

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