Common antiseptic is safe for premature newborns’ skin
27 Feb 2024
A pilot clinical trial has found that a commonly used antiseptic called chlorhexidine (CHG) is safe to apply on the skin of premature newborn babies. Researchers hope this could prevent bacterial infections and sepsis, which are a major cause of death for newborns in hospital.
Results from the NeoCHG pilot trial were published today in eClinicalMedicine. The findings lay the foundations for larger clinical trials to test whether whole-body application of antiseptics can reduce newborn deaths.
Many bacteria usually live harmlessly on the skin, but can cause sepsis if they get inside the body and infect the bloodstream. Worldwide, an estimated 3 million newborn babies develop sepsis every year, and 10-20% of those will die from it. Most cases occur in low- and middle-income countries (LMICs). Premature babies are particularly vulnerable to sepsis as bacteria can pass more easily through their under-developed skin barrier.
CHG is an antiseptic, often used to disinfect specific parts of the body before surgery. Whole-body application of CHG could help prevent deaths from sepsis by reducing bacteria on the skin. Because CHG has a temporary effect, more frequent application at higher concentrations might be more effective at removing bacteria. However, this could risk damaging the skin. There is some evidence that applying emollients such as sunflower oil can protect the skin barrier and may also help prevent infections.
NeoCHG aimed to find out which concentration of CHG, used at what frequency, with or without sunflower oil, would best balance the risks and benefits. The trial took place in two hospitals in South Africa and Bangladesh, involving 208 newborns aged 1-6 days old with a low birthweight.
Researchers tested three different concentrations of CHG (0.5%, 1% or 2%); different application schedules of either every working day or every other working day; and either alone or alongside sunflower oil. They applied CHG to the whole body using soaked cotton wool for 14 days or until the baby was discharged from hospital if this came sooner. A control group received neither CHG nor sunflower oil, which is the current standard of care.
Before applying the antiseptic, researchers checked the condition of the babies’ skin. They also took swab samples every few days to measure changes in the amount of bacteria present on the skin.
NeoCHG found that all the studied concentrations of CHG were safe to apply to the skin of premature newborn babies and did not cause any skin reactions or changes in body temperature. It was also safe to apply sunflower oil alongside.
However, the skin swabs revealed that potentially harmful bacteria and other microbes quickly reappeared on the skin after applying the antiseptic. Worryingly, many of these were resistant to commonly used antibiotics. This occurred regardless of the concentration of CHG used, how frequently it was applied, and whether it was accompanied by sunflower oil. However, as NeoCHG was a pilot trial with a relatively small sample size, its ability to detect small treatment effects was limited.
NeoCHG demonstrates that the tested approaches to whole-body CHG and sunflower oil application are safe and feasible in the context of two busy neonatal hospital units in LMICs. These preliminary results will be used to inform another, larger clinical trial testing whether antiseptics can reduce cases of sepsis and ultimately deaths in premature newborns.
NeoCHG was funded by the MRC Joint Applied Global Health award, the Global Antibiotic Research and Development Partnership (GARDP), MRC Clinical Trials Unit at UCL core funding from UKRI, and St George’s University of London. The MRC CTU at UCL ran the study in collaboration with the Centre for Neonatal and Paediatric Infection at St George’s University of London, the Department of Paediatrics and Child Health at Stellenbosch University/Tygerberg Hospital and the Child Health Research Foundation, Dhaka, Bangladesh.
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