The Budesonide In Babies (BiB) Study for Premature Infants
Randomized Controlled Trial of Budesonide + Surfactant versus Surfactant Alone in Extremely Preterm Infants ("The Budesonide in Babies (BiB) Trial")
This study enrolls infants who are very premature. The purpose of the study is to learn which medications can help very premature babies breathe more easily.
A medicine called surfactant is commonly used to treat the underdeveloped lungs of a premature baby. The surfactant coats the inside of the lungs and helps babies to breathe easier. The purpose of this study is to find out if using a steroid called budesonide mixed together with the surfactant will help reduce chronic lung disease called bronchopulmonary dysplasia (BPD) better than giving the surfactant alone. Both medicines are commonly used to treat premature babies. Babies enrolled will be randomly assigned (like the flip of a coin) to get surfactant alone or surfactant and budesonide together. The medicine will be given within 50 hours of birth. Information will be collected from the baby's medical record about their hospitalization, and at a 2 year follow-up visit. Study takes place at Oishei Children's Hospital in Buffalo, NY.
This is a Phase 3, randomized, masked, active-controlled, multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant, as compared to surfactant alone, will reduce the incidence of physiologic bronchopulmonary dysplasia (BPD) or death by 36 weeks' post-menstrual age in extremely preterm infants.
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Children (infants) who have just been born.
Infants born between 22 and 28 weeks gestation OR 401-1000 grams birth weight.
Infant's physician has decided to treat them with surfactant.
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