November 6, 2020
Dexamethasone, a Steroid, Saves Lives of Early Preterm Babies in Low-Resource Settings, New Study Finds
The results of a new clinical trial, published on October 23, 2020, in the New England Journal of Medicine, show that dexamethasone, a glucocorticoid, can improve survival of premature babies when given to pregnant women at risk of early preterm birth in low-resource settings.
The findings show that 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, improving the chances of survival.
Conducted in Bangladesh, India, Kenya, Nigeria, and Pakistan, the WHO Antenatal Corticosteroids for Improving Outcomes in Preterm Newborns (ACTION-I) Trial was a randomized controlled trial that included 2,852 women who were at risk of giving birth from the 26th week of their pregnancy through their 33rd week and their 3,070 babies.
“Steroids are key to preterm infant survival, but only when combined with accurate pregnancy dating and a minimum standard of care—a key issue that must be considered when using this lifesaving intervention,” says Abdullah Baqui, MBBS, DrPH ’90, MPH ’85, director of the International Center for Maternal and Newborn Health and a professor of International Health at the Johns Hopkins Bloomberg School of Public Health. Baqui served as the principal investigator of the Bangladesh site. He is also one of the study authors and a member of the study’s steering committee.
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 WHO ACTION-I Trial required accurate gestation age dating due to findings from an earlier study showing that the steroid could cause adverse effects if administered after the 37th week of pregnancy. Healthcare providers in the study were therefore equipped with ultrasounds to accurately date pregnancies. In addition, the study notes that preterm infants are most likely to benefit from the drug if it is administered at least 24 hours, and ideally 48 hours, before birth. The health facilities must also be able to administer sufficiently good quality care when babies are born.
Conducted from December 2017 through November 2019, the trial recruited pregnant women from 29 secondary and tertiary level hospitals in Bangladesh, India, Kenya, Nigeria, and Pakistan. In addition to finding a significantly lower risk of neonatal death and stillbirth among early preterm births, the study also found there was no increase in possible maternal bacterial infections when treating pregnant women with dexamethasone in low-resource settings. The WHO is leading the development of a new study to evaluate the drug’s effect in late premature pregnancies (34 – 36 weeks).
In addition to Baqui, Professor Mohammad Shahidullah and Professor Saleha Chowdhury of Bangabandhu Sheikh Mujib Medical University in Dhaka, Bangladesh, served as study site co-principal investigators. The site, located in Sylhet District, Bangladesh, is managed by the Projahnmo Study Group, a Johns Hopkins University research partnership with the Bangladesh Ministry of Health and Family Welfare and other Bangladeshi institutions including academia and NGOs. Established in 2001, research conducted on the site continues to influence key national and global health policies.
Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries was written by The WHO ACTION Trials Collaborators. Johns Hopkins authors include Baqui and Rasheda Khanam, MBBS, PhD, MPH, an assistant scientist of International Health at the Bloomberg School.