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

The WHO ACTION-I trial resolves an ongoing controversy about the efficacy of antenatal steroids for improving preterm newborn survival in low-income countries. Dexamethasone and similar drugs have long shown to be effective in saving preterm babies lives in high-income countries, where high-quality newborn care is more accessible. This is the first time a clinical trial has proven that the drugs are also effective in low-income settings.

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

“Dexamethasone is now a proven drug to save babies born too soon in low-income settings,” says Dr Olufemi Oladapo, head of maternal and perinatal health unit at WHO and HRP, and one of the coordinators of the study. “But it is only effective when administered by health-care providers who can make timely and accurate decisions, and provide a minimum package of high-quality care for both pregnant women and their babies.”

Globally, prematurity is the leading cause of death in children under the age of 5. Every year, an estimated 15 million babies are born too early, and 1 million die due to complications resulting from their early birth. In low-income settings, half of the babies born at or below 32 weeks die due to a lack of feasible, cost-effective care.

The study notes, healthcare providers must have the means to select the women most likely to benefit from the drug and to correctly initiate the treatment at the right time ideally 48 hours before giving birth to give enough time to complete steroid injections for maximal effect. Women who are in weeks 26-34 of their pregnancy are most likely to benefit from the steroid, so healthcare providers must also have access to ultrasound to accurately date their pregnancies. In addition, babies must receive sufficiently good-quality care when they are born.

“When a minimal package of care for newborn babies – including management of infection, feeding support, thermal care and access to a CPAP machine to support respiration – is in place in low-income countries, antenatal steroids such as dexamethasone can help to save preterm babies’ lives,” says Dr Rajiv Bahl, head of the newborn health unit at WHO and one of the study coordinators.

Conducted from December 2017–November 2019, the randomized trial recruited 2852 women and their 3070 babies from 29 secondary and tertiary level hospitals in Bangladesh, India, Kenya, Nigeria, and Pakistan. Beyond finding a significantly lower risk of neonatal death and stillbirth, the study also found there was no increase in possible maternal bacterial infections when treating pregnant women with dexamethasone in low-resource settings.

Note to editors

WHO includes dexamethasone in its Essential Medicines List. The drug has also recently been shown to be effective in helping to relieve the symptoms caused by severe COVID-19. It is therefore crucial that countries, health systems, and pharmaceutical companies across the world ensure quality, as well as effective supply chains and pricing to prevent hoarding or stock-outs of this drug, which has many uses; including for helping to save preterm babies lives.