Whole body application of CHG antiseptic is safe for hospitalised, premature newborns

17 Apr 2023

A commonly used antiseptic is safe to apply on the skin of premature newborns, according to results from the NeoCHG pilot trial presented today at the 2023 ECCMID conference in Copenhagen. The findings pave the way for larger clinical trials to test how well antiseptics can prevent newborn babies dying from bacterial infections.

Sepsis is a major cause of death in newborn babies – especially in low- and middle-income countries. Worldwide, there are an estimated 3 million cases per year with a 10-20% mortality rate. Many bacteria usually live harmlessly on the skin but can lead to sepsis if they get inside the body. Premature babies are particularly vulnerable to sepsis.

One way to reduce the number of bacteria on the skin, and possibly lower the risk of death from sepsis, is applying an antiseptic called chlorhexidine (CHG). Because CHG has a temporary effect, the team believed that applying it more frequently and at higher concentrations might be more effective at removing bacteria. However, this could risk damaging premature babies’ fragile skin.

There is some evidence that using sunflower oil to soothe and moisturise the skin can protect the skin barrier and may also help prevent infections.

NeoCHG is a pilot study which tested different ways of applying CHG to hospitalised newborn babies with a low birthweight. This trial wanted to find:

  • The best concentration of CHG to use
  • The best frequency of application
  • Whether it is beneficial to use chlorhexidine alongside sunflower oil.

NeoCHG took place at two hospitals in South Africa and Bangladesh. It included 208 newborns aged 1-6 days. Researchers randomly assigned the babies into groups and applied CHG to their skin in different ways. They 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 tested CHG alone or alongside sunflower oil.

The control group was given no CHG or sunflower oil, which is the current standard of care.

Researchers checked the condition of the babies’ skin before each application of CHG for 14 days or until they were discharged from hospital if this happened sooner. They also measured the bacteria present on the babies’ skin by taking swab samples every few days.

The team found that all the studied concentrations of CHG were safe and did not cause skin reactions or changes in body temperature. Applying sunflower oil with CHG was also safe.

Skin swabs showed that potentially harmful bacteria very quickly reappeared on the babies’ skin after applying the antiseptic. This occurred no matter the concentration of CHG used, how frequently it was applied, or whether sunflower oil was also used. However, as NeoCHG was a pilot trial with a relatively small sample size, its ability to detect small treatment effects was limited.

After showing that CHG is safe to use in this manner and that it was possible to recruit such young babies with parental consent, these preliminary results will be used to inform another, larger clinical trial. This will focus on whether skin antiseptics can reduce cases of sepsis and ultimately deaths in premature newborns.

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