Steroids enhance the survival of premature babies in low-resource conditions, new research reveals

Precise dating of pregnancy and quality care in combination with steroids are key to survival

The results of a new clinical trial, published today in New England Journal of Medicine, show that dexamethasone – a glucocorticoid used to treat many conditions, including rheumatic problems and severe COVID-19 – can enhance the survival of premature babies if given to pregnant women at risk of preterm birth in low-resource settings.

The WHO ACTION-I trial is resolving the ongoing controversy about the effectiveness of antenatal steroids in improving premature infant survival in low-income countries. Dexamethasone and similar drugs have long been shown to be effective in saving the lives of preterm infants in high-income countries, where high-quality neonatal care is more affordable. This is the first time that a clinical trial has proven that the drugs are effective in low-income environments as well.

The effect is significant: for every 25 pregnant women treated with dexamethasone, the life of one premature infant was saved. When given to mothers at risk of preterm birth, dexamethasone crosses the placenta and accelerates lung development, making it less likely that premature babies have respiratory problems at birth.

“Dexamethasone is now a proven drug for rescuing babies born prematurely in low-income settings,” he says. Dr. Olufemi Oladapo, head of the maternal and perinatal health unit at WHO and HRP, and one of the study coordinators. “But it’s only effective if it’s provided by healthcare providers who can make timely and accurate decisions and provide a minimal package of high-quality care for pregnant women and their babies.”

Globally, premature infants are the leading cause of death in children under 5 years of age. It is estimated that 15 million babies are born prematurely each year, and one million die due to complications resulting from early birth. In low-income settings, half of children born at 32 or less than 32 weeks die from a lack of viable, cost-effective care.

The study notes that health care providers must have the means to select women who are more likely to benefit from the drug and to start treatment properly at the right time – ideally 48 hours before childbirth to give enough time to complete steroid injections to achieve maximum effect. Women who are in the 26th to 34th week of pregnancy are most likely to benefit from steroids, so health care providers must also have access to ultrasound to accurately determine pregnancy. In addition, babies need to get enough quality care when they are born.

“When a minimum neonatal care package is in place in low-income countries – including infection management, feeding support, thermal care and access to a CPAP respiratory support device, antenatal steroids like dexamethasone can help save premature babies’ lives,” he says. Dr. Rajiv Bahl, Head of the Newborn Health Unit at the WHO and one of the study coordinators.

A randomized trial, conducted from December 2017 to November 2019, recruited 2,852 women and their 3,070 babies from 29 hospitals at the secondary and tertiary levels in Bangladesh, India, Kenya, Nigeria and Pakistan. In addition to finding a significantly lower risk of neonatal death and stillbirth, the study also found that there was no increase in possible maternal bacterial infections during treatment of pregnant women with dexamethasone in low-resource environments.

Note to editors

The WHO includes dexamethasone in its list of essential drugs. The drug has also recently been shown to be effective in relieving symptoms caused by severe COVID-19. It is therefore crucial that states, health systems and pharmaceutical companies around the world ensure quality as well as effective supply chains and prices to prevent the accumulation or stockpiling of this widely used drug; including to help save premature babies.