Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to 1 of 3 treatment groups. The first group receives intravenous dexamethasone tapered over 42 days. The second group receives daily intravenous dexamethasone for 6 days, then intravenous methylprednisolone (MePRDL) tapered over the next 34 days, beginning on day 8. A placebo is given on "off" MePRDL days. The third group receives an intravenous placebo for 42 days, with a tapering schedule beginning day 35. All patients may receive 6 days of dexamethasone rescue therapy beginning day 15 and/or 30, as clinically indicated. Study drugs are suspended during rescue therapy.