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孟加拉国锡尔赫特地区,使用 4.0%洗必泰溶液对脐部进行清洁对新生儿死亡率和脐炎的影响:一项基于社区的整群随机试验设计。

Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial.

机构信息

Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

出版信息

BMC Pediatr. 2009 Oct 21;9:67. doi: 10.1186/1471-2431-9-67.

DOI:10.1186/1471-2431-9-67
PMID:19845951
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2770449/
Abstract

BACKGROUND

The World Health Organization recommends dry cord care for newborns but this recommendation may not be optimal in low resource settings where most births take place in an unclean environment and infections account for up to half of neonatal deaths. A previous trial in Nepal indicated that umbilical cord cleansing with 4.0% chlorhexidine could substantially reduce mortality and omphalitis risk, but policy changes await additional community-based data.

METHODS

The Projahnmo Chlorhexidine study was a three-year, cluster-randomized, community-based trial to assess the impact of three cord care regimens on neonatal mortality and omphalitis. Women were recruited mid-pregnancy, received a basic package of maternal and neonatal health promotion messages, and were followed to pregnancy outcome. Newborns were visited at home by local village-based workers whose areas were randomized to either 1) single- or 2) 7-day cord cleansing with 4.0% chlorhexidine, or 3) promotion of dry cord care as recommended by WHO. All mothers received basic messages regarding hand-washing, clean cord cutting, and avoidance of harmful home-base applications to the cord. Death within 28 days and omphalitis were the primary outcomes; these were monitored directly through home visits by community health workers on days 1, 3, 6, 9, 15, and 28 after birth.

DISCUSSION

Due to report in early 2010, the Projahnmo Chlorhexidine Study examines the impact of multiple or single chlorhexidine cleansing of the cord on neonatal mortality and omphalitis among newborns of rural Sylhet District, Bangladesh. The results of this trial will be interpreted in conjunction with a similarly designed trial previously conducted in Nepal, and will have implications for policy guidelines for optimal cord care of newborns in low resource settings in Asia.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT00434408).

摘要

背景

世界卫生组织建议对新生儿进行干燥脐带护理,但在资源匮乏的环境中,这种建议可能并不理想,因为大多数分娩都是在不卫生的环境中进行的,而感染占新生儿死亡的一半。尼泊尔之前的一项试验表明,用 4.0%洗必泰清洗脐带可以显著降低死亡率和脐炎风险,但政策改变还需要更多基于社区的数据。

方法

Projahnmo 洗必泰研究是一项为期三年、以社区为基础的、集群随机对照试验,旨在评估三种脐带护理方案对新生儿死亡率和脐炎的影响。孕妇在妊娠中期被招募,接受了基本的母婴健康促进信息包,并在妊娠结局时得到随访。由当地的村级工作人员对新生儿进行家访,这些工作人员所在的地区被随机分为三组:1)用 4.0%洗必泰进行单次或 7 天脐带清洗,2)推广世卫组织推荐的干燥脐带护理,3)仅进行基本的卫生教育。所有产妇都接受了基本的信息教育,包括洗手、清洁脐带切割和避免在家中使用有害的脐带护理用品。28 天内死亡和脐炎是主要结局;这些结局通过社区卫生工作者在出生后第 1、3、6、9、15 和 28 天的家访直接监测。

讨论

由于要在 2010 年初报告,Projahnmo 洗必泰研究检查了在孟加拉国锡尔赫特区农村,对新生儿进行多次或单次洗必泰脐带清洗对新生儿死亡率和脐炎的影响。该试验的结果将与之前在尼泊尔进行的一项类似设计的试验一起解释,并将对亚洲资源匮乏环境中新生儿最佳脐带护理的政策指南产生影响。

试验注册

ClinicalTrials.gov(NCT00434408)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40c4/2770449/1532a74fb4c8/1471-2431-9-67-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40c4/2770449/4f17ecb96b82/1471-2431-9-67-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40c4/2770449/ee428e065b45/1471-2431-9-67-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40c4/2770449/1532a74fb4c8/1471-2431-9-67-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40c4/2770449/4f17ecb96b82/1471-2431-9-67-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40c4/2770449/ee428e065b45/1471-2431-9-67-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40c4/2770449/1532a74fb4c8/1471-2431-9-67-3.jpg

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