Efficacy and safety of chlorhexidine cleansing in reducing bacterial skin colonisation of hospitalised low birthweight neonates:a pilot trial (NeoCHG)

这是一项初步研究，旨在找出将一种名为氯己定的杀菌剂应用于入院的低出生体重新生儿皮肤的最佳方法。我们想这么做是因为这些婴儿的皮肤上有细菌，就像年长的儿童和成年人一样，但在非常小的婴儿身上，这些细菌更容易进入血液，使他们严重不适。这项研究将计算出抗菌剂的最佳强度，以及它应该使用的频率，以及它是否应该与皮肤柔软剂（称为润肤剂）结合使用，这可以在未来的更大规模的研究中进行测试。这项未来的研究旨在减少这些新生儿的死亡率，但目前我们还不知道哪种类型的皮肤清洁最有可能做到这一点。所以在这个初步研究中，我们将看看不同的方法能在多大程度上减少皮肤上的细菌数量。我们也会每天检查新生儿的皮肤，确保它是安全的。已证明，在新生儿死亡率高的地区，在家中将氯己定用于新生儿的脐带，可降低因感染而死亡的风险。然而，目前仍不确定在体内使用氯己定是否能降低住院新生儿感染和死亡的风险，以及由于其他因素（如出生体重低）感染风险较高的新生儿。此外，在一些研究中，皮肤柔软剂（通常以油的形式存在，如葵花籽油）已被证明可以减少感染，尽管最近的一项综述尚无定论。结合皮肤柔软剂和杀菌剂的效果可能有额外的未被发现的好处，但尚未得到充分的测试，因此本研究也将评估这种组合。该试验将在两家医院进行，一家在孟加拉国，另一家在南非。新生儿从2天大开始，每天（周一至周五）或每周（周一、周三、周五）三次使用洗必定湿巾涂抹于身体皮肤。此外，每组一半的人也会得到皮肤柔软剂。我们将从新生儿皮肤的各个部位取拭子，我们将计算这些拭子上生长的细菌数量。此外，我们将密切监测新生儿的皮肤是否对氯己定有任何反应。通过这种方式，这项研究将提供关于不同方法在减少细菌数量和保持安全方面的平衡的信息。使用或不使用皮肤柔软剂的最佳浓度和使用频率将在未来的更大规模试验中进行测试。更大规模的试验将能够测试在住院的低出生体重新生儿皮肤上使用氯己定是否能降低他们患严重感染的风险，以及这是否能提高他们的存活率。

This is a pilot study to work out the best way to apply an antiseptic called chlorhexidine to the skin of low birth weight newborn babies who are admitted to hospital. We want to do this because these babies have bacteria living on their skin, just like older children and adults, but in very small babies these bacteria can more easily get into the blood and make them seriously unwell. This study will work out the best strength of the antiseptic, as well as how often it should be applied, and whether or not it should be combined with a skin softener (called emollient), that could be tested in a larger study in the future. This future study would aim to reduce deaths in these newborns, but at the moment we don't know what type of skin cleansing would have the best chance of doing this. So in this pilot study, we will look at how much the different methods reduce counts of bacteria on the skin. We will also look at the newborns skin every day to make sure it is safe. The antiseptic chlorhexidine has been shown to reduce the risk of dying from infection when it is applied to the umbilical cord in newborns at home in regions with high rates of newborn deaths. However it is still uncertain whether applying chlorhexidine to the body could reduce the risk of infection and death in newborns who are in hospital and also at high risk of infection due to other factors such as low birth weight. In addition, skin softeners, which are often in the form of oils such as sunflower oil, have been shown in some studies to reduce infections, although a recent review was inconclusive. The effect of combining both skin softeners and an antiseptic may have additional undiscovered benefits but has not been adequately tested, therefore this study will also assess this combination. The trial will be conducted in 2 hospitals, one in Bangladesh, and the other in South Africa. Chlorhexidine wipes will be applied to the skin of the body of newborn babies, starting at from 2 days of age and either daily (Monday-Friday) or three times a week (Monday, Wednesday and Friday) thereafter. In addition, half of each group will receive a skin softener as well. Swabs will be taken from various areas of the skin of the newborns, and we will count the number of bacteria growing from these swabs. In addition, we will monitor the skin of the newborns closely for any signs of reaction to the chlorhexidine. In this way, the study will provide information on the balance between how good the different methods are at reducing bacterial counts, whilst remaining safe. The best concentration and frequency of application, with or without skin softener, will then be chosen to be tested in the larger trial in the future. The larger trial would be able to test whether applying chlorhexidine to the skin of hospitalised low birth weight newborns reduces their risk of getting serious infections, and whether this improves their survival.