Strategies to reduce vertical transmission of multi-drug resistant pathogens to neonates (NeoVT-AMR)

过去二十年来，在减少世界上最贫穷国家幼儿死亡率方面取得了重大进展，但新生儿死亡率仍然很高。细菌感染是全世界新生儿患病和死亡的最常见原因之一，但在低收入环境中问题尤其严重。对常用抗生素的耐药性越来越多地出现在影响幼儿的感染中，在一些国家，这导致婴儿出现严重感染，而当地可用的抗生素无法治疗。迫切需要廉价、有效、现成的战略来减少新生儿感染。婴儿通常在出生后不久就被寄生在皮肤上的细菌感染。因此，减少婴儿感染的一种方法可能是在分娩妇女的产道和新生儿的皮肤上使用防腐剂，以减少婴儿皮肤上发现的细菌数量。要弄清楚使用防腐剂是否可以减少婴儿感染的数量，需要在多个地点进行大型、复杂的试验，但目前尚不知道用于此类试验的最佳防腐剂方案。我们提出的研究旨在提供这些信息。我们计划比较两种不同的消毒剂，这是在医院常规使用的婴儿和产妇护理：氯己定（CHG）和辛替尼定（OCT）。我们将看看这两种杀菌剂在应用于母亲的产道和婴儿的皮肤时是如何减少细菌数量的。我们还将比较使用防腐剂的不同频率，以确定哪种计划效果最好。这项研究将招募到马拉维（世界上最贫穷的国家之一）一家政府医院就诊的妇女和婴儿，并将分配他们接受一种消毒方案。在使用杀菌剂后，将使用皮肤拭子测试产道（妇女）和皮肤（婴儿）中存在的细菌数量。这项研究将仔细收集关于抗菌剂是否会引起皮肤刺激或任何其他问题的数据，并将收集妇女在分娩时使用抗菌剂的可接受程度的数据。作为这项研究的一部分，我们收集的信息将有助于决定我们如何设计未来的大型研究，看看防腐剂是否能减少婴儿中发生的严重感染的数量。

Major progress has been made over the last two decades in reducing deaths in young children from the world's poorest countries, however death rates in newborn babies remain high. Bacterial infection is one of the commonest causes of illness and death in newborn babies across the world but is particularly problematic in low income settings. Resistance to commonly used antibiotics is increasingly seen in infections affecting young babies, and in some countries this is resulting in babies developing serious infections which cannot be treated with locally available antibiotics. Cheap, effective, readily available strategies to reduce neonatal infections are urgently required. Babies are often infected by bacteria that colonise their skin shortly after they are born. One method of reducing infection in young babies could therefore be to apply antiseptics to the birth canal of women in labour and to the skin of newborn babies to reduce the number of bacteria found on babies' skin. Finding out whether antiseptic use could reduce the number of babies developing infections will need a large, complex trial over multiple sites, but currently the best antiseptic regime to use for such a trial is not known. Our proposed study sets out to provide this information. We plan to compare two different antiseptics which are used routinely in hospitals in the care of babies and women in labour: chlorhexidine (CHG) and octenidine (OCT). We will look at how well these two antiseptics reduce the amount of bacterial present when they are applied to the birth canal of a mother and to the skin of a baby. We will also compare different frequencies of applying the antiseptics to determine which schedule works best.The study will enroll women and babies presenting to a government hospital in Malawi, one of the poorest countries in the world, and will allocate them to receive one of the antiseptic regimes. The number of bacteria present in the birth canal (women) and skin (babies) after antiseptic is applied will be tested using skin swabs. This study will carefully collect data on whether antiseptic causes skin irritation or any other problems, and will collect data from women about how acceptable it is to have antiseptic applied whilst they are in labour. The information we collect as part of this study will help decide how we design a future large study to see if antiseptics can reduce the number of serious infections occurring in young babies.