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本文引用的文献

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Global, regional, and national progress towards Sustainable Development Goal 3.2 for neonatal and child health: all-cause and cause-specific mortality findings from the Global Burden of Disease Study 2019.全球、区域和国家在实现可持续发展目标 3.2 方面的进展：2019 年全球疾病负担研究中新生儿和儿童健康的全因和病因特异性死亡率结果。
Lancet. 2021 Sep 4;398(10303):870-905. doi: 10.1016/S0140-6736(21)01207-1. Epub 2021 Aug 17.
2
"Seconds save lives-clean your hands": the 5 May 2021 World Health Organization SAVE LIVES: Clean Your Hands campaign.“秒秒关乎生命——清洁双手”：2021年5月5日世界卫生组织“挽救生命：清洁双手”运动。
Antimicrob Resist Infect Control. 2021 Mar 17;10(1):55. doi: 10.1186/s13756-021-00926-7.
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Aetiology of invasive bacterial infection and antimicrobial resistance in neonates in sub-Saharan Africa: a systematic review and meta-analysis in line with the STROBE-NI reporting guidelines.撒哈拉以南非洲地区新生儿侵袭性细菌感染和抗菌药物耐药的病因学：一项基于 STROBE-NI 报告规范的系统评价和荟萃分析。
Lancet Infect Dis. 2019 Nov;19(11):1219-1234. doi: 10.1016/S1473-3099(19)30414-1. Epub 2019 Sep 12.
4
Hand Hygiene Compliance in the ICU: A Systematic Review.重症监护病房手卫生依从性：系统评价。
Crit Care Med. 2019 Sep;47(9):1251-1257. doi: 10.1097/CCM.0000000000003868.
5
BabyGel pilot: a pilot cluster randomised trial of the provision of alcohol handgel to postpartum mothers to prevent neonatal and young infant infection-related morbidity in the community.BabyGel试点项目：一项关于向产后母亲提供酒精洗手液以预防社区中新生儿和幼儿感染相关疾病的群组随机对照试验。
Pilot Feasibility Stud. 2019 Mar 26;5:49. doi: 10.1186/s40814-019-0432-7. eCollection 2019.
6
In search of a primary outcome for community-based newborn infection trials in Eastern Uganda: a nested cohort study within the BabyGel pilot trial.在乌干达东部开展的基于社区的新生儿感染试验中寻找主要结局指标：一项在BabyGel试点试验中的巢式队列研究
Pilot Feasibility Stud. 2019 Mar 13;5:43. doi: 10.1186/s40814-019-0428-3. eCollection 2019.
7
Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on child stunting and anaemia in rural Zimbabwe: a cluster-randomised trial.改善水、环境卫生和个人卫生以及改善补充喂养对津巴布韦农村儿童发育迟缓与贫血的独立和联合影响：一项群组随机试验。
Lancet Glob Health. 2019 Jan;7(1):e132-e147. doi: 10.1016/S2214-109X(18)30374-7.
8
Preventing neonatal sepsis in rural Uganda: a cross-over study comparing the tolerance and acceptability of three alcohol-based hand rub formulations.在乌干达农村预防新生儿败血症：三种醇基洗手液配方的耐受性和可接受性的交叉研究。
BMC Public Health. 2018 Nov 20;18(1):1279. doi: 10.1186/s12889-018-6201-3.
9
Population-based rates, timing, and causes of maternal deaths, stillbirths, and neonatal deaths in south Asia and sub-Saharan Africa: a multi-country prospective cohort study.南亚和撒哈拉以南非洲地区基于人群的孕产妇死亡、死产和新生儿死亡的发生率、时间和原因：一项多国前瞻性队列研究。
Lancet Glob Health. 2018 Dec;6(12):e1297-e1308. doi: 10.1016/S2214-109X(18)30385-1. Epub 2018 Oct 22.
10
Alcohol-based hand rub and incidence of healthcare associated infections in a rural regional referral and teaching hospital in Uganda ('WardGel' study).基于酒精的手部消毒剂与乌干达农村地区转诊和教学医院中与医护相关的感染发生率（“WardGel”研究）。
Antimicrob Resist Infect Control. 2017 Dec 28;6:129. doi: 10.1186/s13756-017-0287-8. eCollection 2017.

一项评价家用酒精基手部搓揉液预防乌干达婴儿败血症、腹泻和肺炎有效性的整群随机试验（BabyGel 试验）：研究方案。

A cluster randomised trial to evaluate the effectiveness of household alcohol-based hand rub for the prevention of sepsis, diarrhoea, and pneumonia in Ugandan infants (the BabyGel trial): a study protocol.

机构信息

Faculty of Health Sciences, Busitema University, Mbale, Uganda.

Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.

出版信息

Trials. 2023 Apr 17;24(1):279. doi: 10.1186/s13063-023-07312-1.

DOI:10.1186/s13063-023-07312-1
PMID:37069595
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10106319/
Abstract

BACKGROUND

Infections are one of the leading causes of death in the neonatal period. This trial aims to evaluate if the provision of alcohol-based hand rub (ABHR) to pregnant women for postnatal household use prevents severe infections (including sepsis, diarrhoea, pneumonia, or death) among infants during the first three postnatal months.

METHODS

Through a cluster-randomised trial in eastern Uganda, 72 clusters are randomised in a 2-arm design with rural villages as units of randomisation. We estimate to include a total of 5932 pregnant women at 34 weeks of gestation. All women and infants in the study are receiving standard antenatal and postnatal care. Women in the intervention group additionally receive six litres of ABHR and training on its use. Research midwives conduct follow-up visits at participants' homes on days 1, 7, 28, 42, and 90 after birth and telephone calls on days 14, 48, and 60 to assess the mother and infant for study outcomes. Primary analyses will be by intention to treat.

DISCUSSION

This study will provide evidence on the effectiveness of a locally available and low-cost intervention in preventing neonatal sepsis and early infant infections. If ABHR is found effective, it could be implemented by adding it to birthing kits.

TRIAL REGISTRATION

Pan African Clinical Trial Registry, PACTR202004705649428. Registered 1 April 2020, https://pactr.samrc.ac.za/ .

摘要

背景

感染是新生儿期死亡的主要原因之一。本试验旨在评估为产后家庭使用提供酒精基手部消毒剂（ABHR）是否能预防婴儿在出生后三个月内发生严重感染（包括败血症、腹泻、肺炎或死亡）。

方法

通过乌干达东部的一项整群随机试验，以农村村庄为随机单位，将 72 个群组随机分为 2 组。我们估计总共纳入 5932 名妊娠 34 周的孕妇。所有参与研究的妇女和婴儿都接受标准的产前和产后护理。干预组的妇女另外还会收到 6 升 ABHR 以及使用培训。研究助产士在产后第 1、7、28、42 和 90 天进行家庭随访，并在第 14、48 和 60 天通过电话对母亲和婴儿进行评估，以评估研究结果。主要分析将采用意向治疗。

讨论

本研究将提供有关在预防新生儿败血症和婴儿早期感染方面，一种当地可获得且低成本干预措施的有效性证据。如果 ABHR 被证明有效，可通过将其添加到分娩套件中进行实施。

试验注册

泛非临床试验注册处，PACTR202004705649428。于 2020 年 4 月 1 日注册，https://pactr.samrc.ac.za/。