Clinical trial shows steroid a preterm lifesaver

A landmark clinical trial supported by Burnet Institute and the World Health Organization (WHO) has demonstrated the effectiveness dexamethasone, a glucocorticoid, in helping to save the lives of preterm newborn babies in low-resource countries.

The WHO ACTION-I (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns) trial found that one preterm newborn baby’s life was saved for every 25 pregnant women treated with dexamethasone.

Globally, prematurity is the leading cause of death in children under the age of five years.

Every year, an estimated 15 million babies are born too early, and one million die due to complications resulting from their early birth.

In low-income settings, half of the babies born at or below 32 weeks (two months early) die due to a lack of feasible, cost-effective care.

Burnet Institute Principal Research Fellow, Associate Professor Joshua Vogel was an investigator on the WHO ACTION-I trial, conducted over two years in 29 hospitals in Bangladesh, India, Kenya, Nigeria and Pakistan.

The results, published in the New England Journal of Medicine, show that dexamethasone is effective in preventing death due to respiratory problems in preterm newborns, when used as part of quality-care package for women and their babies.

“In Australia, we are accustomed to giving steroids to women who will give birth before 34 weeks of pregnancy,” Associate Professor Vogel said.

“So when the baby is born they’re less likely to have respiratory problems and by extension, there’s reduced mortality.

“This is the first trial to demonstrate that this drug works when it’s used in low-resource countries, in hospitals that are adequately equipped to look after a mother and her preterm newborn.”

This standard of care might typically include access to ultrasound to provide a reliable estimate of a woman’s gestational age; informed decision-making by health care providers to select the right pregnant women for treatment; the ability to correctly administer treatment at the tight time; and access to oxygen should the newborn need it.

“Low-resource countries have large burdens of preterm birth and mortality due to preterm birth … and dexamethasone is readily available and affordable,” Associate Professor Vogel said.

“This trial would not have been possible without the collaborative effort of hundreds of researchers and clinicians, working together with WHO to improve preterm care”

“We now know how to use steroids appropriately and safely in these settings where, with the right support and appropriate standard of care, they will save lives.”

Dexamethasone has also recently been shown to be effective in helping to relieve the symptoms caused by severe COVID-19.

This work was co-led by HRP (the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction), within the Department of Sexual and Reproductive Health and Research, WHO; and WHO Department of Maternal, Newborn, Child and Adolescent Health.

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