The simple antiseptic that could save a million newborns

In 2016, 4.2 million children died before their first birthday, many due to easily avoidable causes. That number could be dramatically reduced, especially in developing countries, by a simple chemical commonly found in mouthwash.

Chlorhexidine, a broad-spectrum antiseptic used in everyday items (at a low concentration), can stop umbilical cord infections in newborn babies. According to the Chlorhexidine Working Group (CWG), when used on the first day of life, the antiseptic reduces neonatal mortality by 23%. And what’s more, it costs less than 50 cents.

"In many places there’s been a dramatic reduction in neonatal mortality related to infection"

Led by PATH, the international health organisation, the group are working in 25 countries – predominantly in sub-Saharan Africa and South Asia where there are high rates of neonatal mortality.

Brought to scale, models suggest that one million lives could be saved worldwide. However, studies in Zambia and Tanzania have cast some doubt on whether the intervention works in all contexts, and therefore whether this figure is actually realistic.

How does it work?

“Chlorhexidine itself has been around for a long, long time,” said Dr Patricia Coffey, who leads PATH’s Health Technologies for Women and Children group.

Manufactured as a gel or liquid, the “chlorhexidine digluconate” (CHX) chemical is placed on the tip, base, and all along the cord as soon as possible after birth: at least during the first 24 hours, when the risk of infection is at its highest. This is usually repeated once a day for a week.

“A lot of countries have cultural practices where things are put on the cord anyway, so in this way you can substitute in products we know are not harmful for something which may be,” said Coffey. “It supports and honours that tradition at the country level.”

Also, as opposed to being imported from the other side of the world, PATH work with local manufacturers in South Asia and Africa. “We have to work with manufacturers and producers to make sure we have these solutions which are sustainable and available in the market,” said Coffey. “They may not necessarily have huge markets where you get a lot of returns on your investment.”

"There are a lot of trade-offs in a health budget, so prioritising newborn health and then prioritising chlorhexidine – that’s a struggle"

The impact has been significant in Nepal, Pakistan and Bangladesh. “In many places there’s been a dramatic reduction in neonatal mortality related to infection,” she said.

The most notable example is in Nepal, where over 400,000 newborns have chlorhexidine applied to their umbilical cords each year, estimated to avert approximately 2,000 deaths annually. Introduced by the government from 2001, by June 2017 the chemical had been introduced in all 75 districts in the country.

Importantly, Nepal’s randomised control trial conducted from 2002-05 – showing that chlorhexidine reduced the risk of death by 34% for infants who received the first application within 24 hours of birth – provided a body of evidence to bring the intervention to scale, and to convince other countries to follow suit.

Becoming national policy

“As we’ve raised awareness, countries have been interested in moving forward with introducing it,” said Coffey, “so we’ve been working with them to identify what would be the best way to introduce it in parts of the country.” This includes carrying out analysis on the potential health impact and on pre-existing health policies to align with.

Despite how cheap the drug is, financing it can be problematic for governments with limited resources. “There are a lot of trade-offs in a health budget, so prioritising newborn health and then prioritising chlorhexidine – that’s a struggle since the budgets don’t seem to be able to expand very much year to year,” said Coffey.

"Trials in Tanzania and Zambia found no significant impact of chlorhexidine use on infant mortality"

Once funding is secured, the political structures of each country can have a large impact. “In countries where health systems are devolved, actual implementers or procurers of product are at a sub-national level, like a district,” said Mutsumi Metzler, a senior commercialisation officer in the Devices and Tools Program at PATH.

“In some countries, the coordination between national-level policy and the implementation is going well, but not in others,” she said. “There is a time lapse in those countries.”

In order to facilitate its widespread use in a country, chlorhexidine needs to be added to its Essential Medicines List (EML), which is the responsibility of each individual government. In 2013, the World Health Organisation added CHX to its Model List of Essential Medicines for Children, and formally recommended its use in postnatal care.

But it hasn't helped everywhere

In spite of these international recommendations, a trial in Tanzania and another in Zambia both found no significant impact of chlorhexidine use on infant mortality, directly contradicting the positive trials in South Asia.

Researchers have put forward a number of explanations for this. Where the birth happens could be key, as [53% of newborn babies](http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(16%2930223-6/fulltext) in the Tanzania study and 63% in the Zambia study were born in hospitals, whereas fewer than 20% in the south Asian studies were at health facilities. Meanwhile, only 7% of infants were of low birth weight in Zambia compared with nearly a third of those in the Nepal and Bangladesh studies. Also, the Zambia study gave information about newborn umbilical cord care to both the chlorhexidine and control groups, which may have influenced the results.

While neither African study recommended the WHO should necessarily change course, they cast doubt on whether chlorhexidine has the desired effects in less extreme contexts, and therefore whether the one million figure is a realistic one. The results certainly highlight the need to conduct more analysis to properly explain the differences, which should serve to inform future action.

By extension, there's a question as to whether all governments should spend the money. Unsurprisingly, Tanzania decided against it. “We clearly laid out the evidence for them and then respected their decision as to whether they wanted to move forward with the intervention,” said Coffey. In Nigeria, on the other hand, the Federal Ministry of Health trusted the Nepal results and launched a large-scale plan in 2016 to make the immediate application of chlorhexidine a national standard of care.

While it’s important to get to grips with these inconsistent results, the remarkably low costs of scaling chlorhexidine – saving one million lives has been forecasted cost $81 million internationally from 2015-30 – may well make it a risk worth taking for countries struggling to grapple with poor neonatal health.

(Picture credit: UN Photo/Kibae Park)

Jack Graham
jack.graham@apolitical.co