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

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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.