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

氯己定清洁减少住院低出生体重新生儿皮肤细菌定植的有效性和安全性：一项试点试验 (NeoCHG)

• 批准号: MR/T003928/1
• 负责人: Mike Sharland
• 金额: $ 30.07万
• 依托单位: St George's, University of London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FT003928%2F1
• 关键词: Efficacy; safety; chlorhexidine; cleansing; reducing

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.

这是一项试点研究，旨在找出将一种名为氯己定的防腐剂应用于入院的低出生体重新生儿皮肤的最佳方法。我们想这样做，因为这些婴儿的皮肤上有细菌，就像年龄较大的儿童和成人一样，但在非常小的婴儿中，这些细菌更容易进入血液，使他们严重不适。这项研究将确定防腐剂的最佳强度，以及它应该多久使用一次，以及它是否应该与皮肤软化剂（称为润肤剂）结合使用，这可以在未来的一项更大的研究中进行测试。这项未来的研究旨在减少这些新生儿的死亡，但目前我们不知道什么类型的皮肤清洁剂最有可能做到这一点。因此，在这项初步研究中，我们将看看不同的方法在多大程度上减少了皮肤上的细菌数量。我们也会每天检查新生儿的皮肤，以确保它是安全的。在新生儿死亡率高的地区，抗菌剂洗必泰在家中应用于新生儿脐带时，已被证明可降低因感染而死亡的风险。然而，目前还不确定将洗必泰应用于身体是否可以降低住院新生儿的感染和死亡风险，以及由于其他因素（如低出生体重）而导致的高感染风险。此外，皮肤软化剂，通常是油的形式，如向日葵籽油，已在一些研究中显示，以减少感染，但最近的审查是不确定的。结合皮肤软化剂和防腐剂的效果可能有额外的未发现的好处，但尚未得到充分的测试，因此本研究也将评估这种组合。试验将在2家医院进行，一家在孟加拉国，另一家在南非。洗必泰湿巾将从2日龄开始应用于新生儿身体的皮肤，此后每天（周一至周五）或每周三次（周一、周三和周五）。此外，每组一半的人还将接受皮肤软化剂。将从新生儿皮肤的各个区域采集拭子，我们将计算从这些拭子中生长的细菌数量。此外，我们将密切监测新生儿的皮肤是否有任何对氯己定反应的迹象。通过这种方式，该研究将提供有关不同方法在减少细菌计数同时保持安全性方面的平衡的信息。最佳的浓度和应用频率，有或没有皮肤软化剂，然后将选择在未来的更大的试验进行测试。更大规模的试验将能够测试将氯己定应用于住院低出生体重新生儿的皮肤是否会降低他们患严重感染的风险，以及这是否会提高他们的生存率。