Randomized Controlled Trial of Budesonide + Surfactant

This is a randomized, masked, multicenter clinical trial with allocation to two treatment arms with early intratracheal administration of a combination of budesonide with surfactant (Intervention), as compared to surfactant alone (Control) to reduce the incidence of physiologic bronchopulmonary dysplasia (BPD) in extremely preterm infants. To be included, the infant must be liveborn, 22 0/7-28 6/7 weeks gestation or 401-1000 grams birth weight with clinical decision to give surfactant and early enrollment into the trial so that the first dose of study drug can be administered before or at 50 hour postnatal age. Several exclusion criteria include prior administration of surfactant, steroids, indomethacin, known congenital infection, serious chromosomal abnormalities or major malformations, a permanent neuromuscular condition affecting respiration or terminal illness.

You may be eligible for this study if you meet the following criteria:

• Conditions:
  newborn, preterm, bronchopulmonary dysplasia, pediatrics
• Age: - 99 Years
• Gender: All