This clinical trial is focused on studying a condition known as bronchopulmonary dysplasia (BPD), which affects the lungs of very premature babies. The trial is investigating a treatment called zelpultide alfa, also known by its code name AT-100. This treatment is a type of protein that is similar to a natural substance found in the lungs, called recombinant human surfactant protein-D. The study aims to find out if adding zelpultide alfa to the usual care can help protect the lungs and prevent lung injury in these high-risk infants.
The purpose of the study is to compare the effectiveness of zelpultide alfa combined with the standard care against the standard care plus a placebo, which is a treatment that looks like the real one but has no active ingredients. The trial will involve very premature babies who are at high risk of developing BPD. These babies will receive either the new treatment or the placebo, in addition to the usual care they would normally receive. The study will monitor the babies to see if the new treatment helps reduce the occurrence of severe BPD or death by the time they reach 36 weeks of age, which is a common milestone for assessing lung health in premature infants.
Throughout the study, researchers will also look at other factors, such as the number of days the babies can breathe without the help of a ventilator and the overall survival rate by the 36-week mark. The trial is designed to provide valuable information on whether zelpultide alfa can offer additional protection for the lungs of these vulnerable infants, potentially leading to better outcomes and fewer complications related to BPD.
Belgium 
France 
Germany 
Italy 
Poland 
Portugal 
Spain 