Efficacy and safety of whole-body chlorhexidine gluconate (CHG) cleansing in reducing bacterial skin colonisation of hospitalised neonates: A pilot trial
Prof Mike Sharland is the CI, Dr Neal Russell and Dr Julia Bielicki are co-investigators
Funder
Medical Research Council
Sponsor
St George’s University London
Type of Study
Observational, RCT, Interventional, Phase I
Sites
Hospital neonatal units in South Africa and Bangladesh
Patients
Hospitalised low birth weight (1-2kg) babies between the ages of 1-6 days at enrolment
Summary
This is a pilot study to assess the best way of applying a routine preventive antiseptic to low birth weight newborn babies who are in hospital. The antiseptic aims to reduce the amount of potentially harmful bacteria on the skin of newborn babies. This might be useful for preventing infections which are picked up in hospital.
This study aims to find out the best concentration of antiseptic to use, as well as how often it should be put on the babies, and whether or not it should be combined with a skin softener. In this pilot study, we will see the amount of bacteria babies have on their skin, and look carefully at whether, and how often, skin reactions occur.
The antiseptic we will test in this study is called chlorhexidine. Chlorhexidine has been widely used across the world for many decades to reduce the risk of babies dying from infection. For example, it is put on the umbilical cord of newborn babies at home in areas with high rates of deaths from infections. However, we don’t know whether applying chlorhexidine to the whole body could reduce the risk of infection and death in newborn babies who are in hospital and have a high risk of infection because of other problems, including being premature or low birth weight.