Grant: Project Grant

Around the world, 15 million babies are born too early. Preterm delivery is the main cause of infant death and serious diseases. Steroids given to women at risk of preterm delivery decrease death and disease in babies who are born preterm, especially lung disease. However, research in animals suggests half the dose would mature babies' lungs adequately. This is important because there are concerns that the double doses that are used now may have risks for babies in the long term. We want to see if a single dose is not worse (non-inferior) than the standard two doses given 24 hours apart by injection. In women who are between 22-34 weeks of pregnancy, who have already received the first dose of steroids because they are at risk of early birth, we will randomly allocate (assign) women to receive either a second dose or a matching placebo. We will then follow mothers and infants through to discharge to see if they have any problems, including death or serious disease. We will follow the infants at 18-24 months of age after birth. We will analyze the results, keeping people in their originally assigned groups, and we will also analyze them according to the actual treatment received. To do this work, we have gathered a team of experts in obstetrics, neonatology, methodology and statistics, national organizations and parents. Our team had previously done other large studies which randomly allocate (assign) women to receive various doses of steroids or other treatments during pregnancy. We will convey our results using articles, websites and a video. If we find that one dose is similar to two doses of steroids in the short-term outcomes, fewer babies will be harmed in the long term and this will change practice around the world.