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

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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.