Footprints:
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
The Footprints Study is evaluating a study drug that aims to prevent or reduce lifelong complications due to prematurity, primarily bronchopulmonary dysplasia (BPD), the most common cause of chronic lung disease (CLD) of prematurity. The study drug contains a growth factor called insulin-like growth factor 1, or IGF-1. Its significance to the health of preterm babies has been studied for the last few years, and initial findings show that low levels of IGF-1 in the blood may be connected to complications in preterm babies.
This global study has the potential to impact families in the future, and your baby’s participation may help bring forth a treatment option for other babies born prematurely.
The study will enroll extremely preterm babies born between the gestational ages of 23 and less than 28 weeks.
We know that any decision involving a baby’s health requires careful thought and consideration. So we’d like to share some information on the Footprints Study to help you decide whether to participate.
Learn more about BPD and complications of prematurity here: OHB-607 and BPD
Information for Parents
Babies born extremely premature often have problems with their lungs and breathing, immediately after birth and even after they go home from the hospital. Doctors continue to look for medicines to prevent lung and breathing problems, including bronchopulmonary dysplasia (BPD), a type of lung disease unique to babies born prematurely, but no approved treatment has yet been found.
Studies have shown the importance of IGF-1 in relation to prenatal lung development. The study drug contains a manufactured version of IGF-1, which is a naturally occurring protein. Agents such as IGF-1 that promote organ development and drive growth in extremely preterm babies have the potential to address multiple complications of prematurity. In this study, doctors will look at whether or not the increase in IGF-1 levels provided by the study drug reduces the incidence of chronic lung disease and other complications of extreme prematurity.
We have provided the video here to explain more about our trial.
We have also attached some of our educational materials here.
To learn more about the Footprints Study, we encourage you to talk to the participating study doctor.
