Preventing Maternal and Neonatal Bacterial Infections in Developing Settings

在发展中环境中预防孕产妇和新生儿细菌感染

• 批准号: 7491701
• 负责人: Shabir AHMED Madhi
• 金额: $ 24.81万
• 依托单位: MEDICAL RESEARCH COUNCIL OF SOUTH AFRICA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7491701
• 关键词: Preventing; Maternal; Neonatal; Bacterial; Infections

The proposal aims at addressing the burden of disease, risk factorsfor and potential to intervene against neonatal and maternalperi-partum sepsis in a developingcountry setting with a high prevalence(29%)of maternal HIV infection. The study site is a secondary-tertiary hospital in Johannesburg, South Africa. The primary aim of this proposal is to complete a currently underwaydouble-blind randomizedplacebo controlled trial studying the efficacy of chlorhexidine (0.5% solution) intavaginal washes during labor in the mother and subsequentcleansing of the newborn with full-body chlorhexidine wipes, to prevent early -onset (within 72 hours of birth) neonatal sepsis and peri-partum (within 14 days of birth) sepsis in the mother. Based on an estimatedincidence rate of 30 cases of sepsis/1000 life births occuring within 72 hours of birth, we proposeto randomise 8 000 women during labor into one of two arms (chlorhexidine vs. autoclaved tap- water inetnmittent vaginal washes) to detect at least a 40% reduction in the incidence of neonatal sepsis, with 80% power and 95% confidence. The study-outcome measureof neonatalsepsiswill include culture confirmed disease and/or a clinical diagnosis of sepsis based on an algorithm that has been agreed upon by experts in the field. We also plan to measure in a subset of mother-infant pairs the prevalence of vaginal colonisation by bacteria in the mother during labor and the impact of the study-intervention on the incidence of colonisation of the newborn with vaginal bacterial flora. The study will evaluate the effect of the intervention on the incidence of the following specificoutcomes: Primary objectives: 1. Early (within 72 hours of birth) microbiologiocally confirmed and/ or clinically diagnosed neonatalsepsis. 2. Decrease in vertical transmission of colonization with Group B Streptococcus from the mother to the newborn. Secondary objectives: 1. Incidence of community-acquired neonatal sepsis/meningitis between72 hours and 28 days of life. 2. Incidence of peripartum culture-confirmedor clinically diagnosed maternal sepsis within 14 days fo birth. 3. Incidence of colonization of the newbornwith Klebsiela pneumoniaeand E . coli. 4. The burden of disease and risk factors for maternal peripartum infection and serious neonatal infections in SouthAfrica with emphasis on the impact of maternalHIV infection on these outcomeswill also be studied. Relevance: The findings from this study may contribute in sari to realising one of the Millenium goals of the United Nations; i.e. to halve childhood mortality by2015.The leading cause of neonatal deaths, which contribute to at least one-third of all infant deaths, in developingcountries are sepsis and birth asphyxia. Logistical and resource constraints in developing countries prohibit the implementation of strategies that have been successfully in developed countries to reduce neonatal sepsis, therefore a more practical and affordable solution is required for developing countries.

该提案旨在解决疾病，危险因素和潜力的负担，以针对新生儿和孕妇败血症进行干预，并在孕产妇HIV感染的高患病率（29％）的环境中。研究地点是南非约翰内斯堡的一家二级医院。该提案的主要目的是完成目前的双盲随机分组对照试验，研究母亲在劳动期间研究氯己胺（0.5％溶液）的疗效（0.5％溶液）在母亲的劳动过程中，并在早期（在出生后的72个小时内）（在142个小时内）（在142个小时内）（在142个小时内）对新生儿进行新生儿（随后）的疗效（sepsis sepse sepse sepse sepse sepse sepse andpers-part）（母亲。根据估计的含量为30例败血症/1000例生命出生，在分娩后的72小时内出现了生命的出生，我们建议在分娩过程中将8000名妇女随机分解为两个臂之一（氯己胺与自动锁定的tap-水无滴水的阴道洗涤剂）至少降低了40％的信心，并降低了40％的信心，并具有80％的neonatal sepsiss andiss sepsiss，andys sepsiss power，并降低。新生儿的研究结果包括基于该领域的专家同意的算法，包括培养已确认的疾病和/或败血症的临床诊断。我们还计划在母亲对成对的子集中测量母亲在劳动期间细菌在母亲中的阴道定植的流行，以及研究干预对新生儿与阴道细菌菌群定殖的发生率的影响。该研究将评估干预措施对以下特定因素的发生的影响：主要目标：1。早期（出生后72小时）微生物学确认和/或临床诊断为新生儿症。 2。与B组链球菌从母亲到新生儿的垂直传播减少。次要目标：1。社区获得的新生儿败血症/脑膜炎的发生率在72小时至28天之间。 2。周围培养 - 机构临床诊断为孕产妇败血症的发病率在14天内出生。 3。纽伯里亚（Klebsiela）肺炎的殖民发生率。大肠杆菌。 4。疾病的负担和孕产妇周围感染的危险因素和南部的严重新生儿感染，重点是孕产妇感染对这些结果的影响。相关性：这项研究的发现可能有助于萨里实现联合国千年目标之一；即，到2015年，儿童死亡率减半，新生儿死亡的主要原因，在所有婴儿死亡中至少有三分之一的死亡人数是败血症和窒息的出生窒息。发展中国家的后勤和资源限制禁止在发达国家成功实施减少新生儿败血症的战略，因此，发展中国家需要一个更实用，更实惠的解决方案。